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Clinical Study to Examine Brushing on Dental Implants

Clinical Study to Examine Brushing on Dental Implants

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00762619
Enrollment
105
Registered
2008-09-30
Start date
2007-04-30
Completion date
2008-08-31
Last updated
2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Diseases

Brief summary

The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants

Interventions

DRUGFluoride

Brush twice daily

Brush twice daily

Sponsors

Colgate Palmolive
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
Yes

Inclusion criteria

* Males and females in good oral and general health aged 18 to 76 years. * A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate willingness to comply with all study procedures and availability for duration of study. * Subjects will use the provided test articles and discontinue the use of other dentifrices and mouthrinses for the duration of the study. * A minimum of 20 natural teeth with facial and lingual scorable surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count. * Adequate oral hygiene and no signs of oral neglect. * Subjects will have at least one dental implant and a contralateral natural tooth. * At the first visit subjects will be examined by a dentist for periodontal health. * Selected subjects will have periodontal pockets less than 6mm. * Subjects with gingival index equal to or greater than 1.0 and plaque index equal to or greater than or 1. 5 on the implant tooth will be enrolled. Gingival and plaque indices will be measured during the first visit for the implant. Similarly, these clinical indices (Gingival and plaque index) will be determined for the contralateral natural tooth. (The adjacent teeth will serve as a backup for the studies if control tooth is lost during study). * Subjects who are habitual users of Colgate Total or other oral hygiene formulations with antimicrobial agents will complete a washout phase of 30 days with a commercial fluoride dentifrice prior to enrollment in the study. This washout dentifrice will be identified and obtained by the clinical investigator from an appropriate local source.

Exclusion criteria

* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. * Regular use of mouthwash with antimicrobial agents within the past month. * History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS. * History of hepatitis, rheumatic fever, pacemaker, or prosthetic heart valves, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures. * Subjects presenting significant medical conditions or need for long term drug therapy. * Subjects on antibiotic, anti inflammatory or anticoagulant therapy during the month preceding the baseline exam. * Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations) that would interfere with the study. * History of active severe periodontal disease with bleeding gums and loose teeth. * Widespread caries or chronic neglect. Subjects presenting with gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, and large fractured or temporary restorations (based on visual examinations). * Fixed or removable orthodontic appliance or removable partial dentures. * Participation in any clinical study including dental plaque/gingivitis clinical trial involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the month preceding the start of study. * Self reported pregnancy or lactation. * History or current use of objects to pierce the lips or tongue. * Subjects known to be an alcoholic, or a recovering alcoholic. * History or current use of recreational drugs or narcotics. * Determine smoking status of subjects and exclude current smokers. * Determine reason for placing implants in subject to exclude subjects whose implants were placed for trauma.

Design outcomes

Primary

MeasureTime frameDescription
Mombelli Plaque Index (mPI) for Natural Teeth3 monthsModified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Mombelli Plaque Index (mPI) for Dental Implants3 monthsModified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Löe-Silness Gingival Index Score (GI) - Natural Teeth3 monthsGingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Löe-Silness Gingival Index Score (GI)- Dental Implants3 monthsGingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth3 monthsSulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.
Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants3 monthsGingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.
A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).
A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth6 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).
A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant3 months14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).
C.Rectus (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
C.Rectus (DNA Probe Analysis) - Dental Implant3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
E.Corrodens (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
E.Corrodens (DNA Probe Analysis) - Dental Implant3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
E.Saburreum (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
E.Saburreum (DNA Probe Analysis)- Natural Teeth6 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).
E.Saburreum (DNA Probe Analysis) - Dental Implant3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
F.Nucleatum (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).
F.Nucleatum (DNA Probe Analysis) - Dental Implants3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).
Neissera sp. (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Neissera sp. (DNA Probe Analysis) Natural Teeth6 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Neissera sp. (DNA Probe Analysis) - Dental Implants3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Gingivalis (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
P.Gingivalis (DNA Probe Analysis) - Dental Implants3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
P.Intermedia (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Intermedia (DNA Probe Analysis) - Dental Implants3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
T.Forsythia (DNA Probe Analysis)- Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Melaninogenica (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Melaninogenica (DNA Probe Analysis) - Dental Implants3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Streptococci (DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).
Streptococci (DNA Probe Analysis) - Dental Implants3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).
T.Forsythia (DNA Probe Analysis)-Natural Teeth6 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
T.Forsythia (DNA Probe Analysis)- Dental Implants3 months14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Veillonella sp.(DNA Probe Analysis) - Natural Teeth3 months14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)
Veillonella sp.(DNA Probe Analysis) - Dental Implants3 months14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)

Countries

Israel, United States

Participant flow

Recruitment details

subjects were recruited by the PI at the clinical site

Pre-assignment details

subjects were screened for medical and oral health criteria and given the assigned study treatment to brush with for the next 6 months. Enrolled subjects all had 1 dental implant and 1 natural tooth identified and used for clinical data information.

Participants by arm

ArmCount
A - Fluoride Control
Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
55
B - Postive Control
fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
50
Total105

Baseline characteristics

CharacteristicTotalA - Fluoride ControlB - Postive Control
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants2 Participants2 Participants
Age, Categorical
Between 18 and 65 years
101 Participants53 Participants48 Participants
Age Continuous54.95 years
STANDARD_DEVIATION 10.56
54.71 years
STANDARD_DEVIATION 9.6
55.22 years
STANDARD_DEVIATION 11.6
Region of Enrollment
Israel
105 participants55 participants50 participants
Sex: Female, Male
Female
53 Participants29 Participants24 Participants
Sex: Female, Male
Male
52 Participants26 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 550 / 50
serious
Total, serious adverse events
0 / 550 / 50

Outcome results

Primary

A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlA.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant5.664 Log cfu (colony forming units)Standard Error 0.1222
B - Postive ControlA.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant4.339 Log cfu (colony forming units)Standard Error 0.1908
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlA.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant5.814 Log cfu (colony forming units)Standard Error 0.1262
B - Postive ControlA.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant4.446 Log cfu (colony forming units)Standard Error 0.1589
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlA.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth6.269 Log cfu (Colony Forming Units)Standard Error 0.006
B - Postive ControlA.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth5.002 Log cfu (Colony Forming Units)Standard Error 0.1117
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlA.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth6.201 Log cfu (colony forming units)Standard Error 0.1117
B - Postive ControlA.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth4.669 Log cfu (colony forming units)Standard Error 0.1325
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlCapnocytophaga sp. (DNA Probe Analysis) - Dental Implant4.391 Log cfu (colony forming units)Standard Error 0.07532
B - Postive ControlCapnocytophaga sp. (DNA Probe Analysis) - Dental Implant4.243 Log cfu (colony forming units)Standard Error 0.08163
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlCapnocytophaga sp. (DNA Probe Analysis) - Dental Implant4.356 Log cfu (colony forming units)Standard Error 0.07716
B - Postive ControlCapnocytophaga sp. (DNA Probe Analysis) - Dental Implant4.268 Log cfu (colony forming units)Standard Error 0.08752
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlCapnocytophaga sp. (DNA Probe Analysis) - Natural Teeth4.676 Log cfu (colony forming units)Standard Error 0.05921
B - Postive ControlCapnocytophaga sp. (DNA Probe Analysis) - Natural Teeth4.526 Log cfu (colony forming units)Standard Error 0.06476
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
Primary

Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlCapnocytophaga sp. (DNA Probe Analysis) - Natural Teeth4.644 Log cfu (colony forming units)Standard Error 0.07209
B - Postive ControlCapnocytophaga sp. (DNA Probe Analysis) - Natural Teeth4.411 Log cfu (colony forming units)Standard Error 0.07971
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

C.Rectus (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlC.Rectus (DNA Probe Analysis) - Dental Implant4.318 Log cfu (colony forming units)Standard Error 0.1318
B - Postive ControlC.Rectus (DNA Probe Analysis) - Dental Implant2.758 Log cfu (colony forming units)Standard Error 0.2106
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

C.Rectus (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlC.Rectus (DNA Probe Analysis) - Dental Implant4.46 Log cfu (colony forming units)Standard Error 0.1226
B - Postive ControlC.Rectus (DNA Probe Analysis) - Dental Implant3.015 Log cfu (colony forming units)Standard Error 0.1843
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

C.Rectus (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlC.Rectus (DNA Probe Analysis) - Natural Teeth4.69 Log cfu (colony forming units)Standard Error 0.1269
B - Postive ControlC.Rectus (DNA Probe Analysis) - Natural Teeth3.322 Log cfu (colony forming units)Standard Error 0.1548
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

C.Rectus (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlC.Rectus (DNA Probe Analysis) - Natural Teeth4.578 Log cfu (colony forming units)Standard Error 0.1403
B - Postive ControlC.Rectus (DNA Probe Analysis) - Natural Teeth2.798 Log cfu (colony forming units)Standard Error 0.172
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

E.Corrodens (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlE.Corrodens (DNA Probe Analysis) - Dental Implant6.21 Log cfu (colony forming units)Standard Error 0.148
B - Postive ControlE.Corrodens (DNA Probe Analysis) - Dental Implant5.639 Log cfu (colony forming units)Standard Error 0.162
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

E.Corrodens (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlE.Corrodens (DNA Probe Analysis) - Dental Implant6.242 Log cfu (colony forming units)Standard Error 0.1619
B - Postive ControlE.Corrodens (DNA Probe Analysis) - Dental Implant5.482 Log cfu (colony forming units)Standard Error 0.1791
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

E.Corrodens (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlE.Corrodens (DNA Probe Analysis) - Natural Teeth6.417 Log cfu (colony forming units)Standard Error 0.1808
B - Postive ControlE.Corrodens (DNA Probe Analysis) - Natural Teeth5.682 Log cfu (colony forming units)Standard Error 0.1937
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

E.Corrodens (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlE.Corrodens (DNA Probe Analysis) - Natural Teeth6.47 Log cfu (colony forming units)Standard Error 0.1477
B - Postive ControlE.Corrodens (DNA Probe Analysis) - Natural Teeth5.822 Log cfu (colony forming units)Standard Error 0.1583
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

E.Saburreum (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlE.Saburreum (DNA Probe Analysis) - Dental Implant5.012 Log cfu (colony forming units)Standard Error 0.1065
B - Postive ControlE.Saburreum (DNA Probe Analysis) - Dental Implant3.861 Log cfu (colony forming units)Standard Error 0.1222
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

E.Saburreum (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlE.Saburreum (DNA Probe Analysis) - Dental Implant4.733 Log cfu (colony forming units)Standard Error 0.1287
B - Postive ControlE.Saburreum (DNA Probe Analysis) - Dental Implant3.372 Log cfu (colony forming units)Standard Error 0.1728
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

E.Saburreum (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlE.Saburreum (DNA Probe Analysis) - Natural Teeth5.229 Log cfu (colony forming units)Standard Error 0.1199
B - Postive ControlE.Saburreum (DNA Probe Analysis) - Natural Teeth4.385 Log cfu (colony forming units)Standard Error 0.1328
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

E.Saburreum (DNA Probe Analysis)- Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlE.Saburreum (DNA Probe Analysis)- Natural Teeth5.079 Log cfu (colony forming units)Standard Error 0.1424
B - Postive ControlE.Saburreum (DNA Probe Analysis)- Natural Teeth3.571 Log cfu (colony forming units)Standard Error 0.1655
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

F.Nucleatum (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlF.Nucleatum (DNA Probe Analysis) - Dental Implants4.602 Log cfu (colony forming units)Standard Error 0.1348
B - Postive ControlF.Nucleatum (DNA Probe Analysis) - Dental Implants2.425 Log cfu (colony forming units)Standard Error 0.1474
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

F.Nucleatum (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlF.Nucleatum (DNA Probe Analysis) - Dental Implants4.89 Log cfu (colony forming units)Standard Error 0.1277
B - Postive ControlF.Nucleatum (DNA Probe Analysis) - Dental Implants3.637 Log cfu (colony forming units)Standard Error 0.1354
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

F.Nucleatum (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlF.Nucleatum (DNA Probe Analysis) - Natural Teeth5.337 Log cfu (colony forming units)Standard Error 0.1773
B - Postive ControlF.Nucleatum (DNA Probe Analysis) - Natural Teeth4.403 Log cfu (colony forming units)Standard Error 0.123
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

F.Nucleatum (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlF.Nucleatum (DNA Probe Analysis) - Natural Teeth5.243 Log cfu (colony forming units)Standard Error 0.1265
B - Postive ControlF.Nucleatum (DNA Probe Analysis) - Natural Teeth3.405 Log cfu (colony forming units)Standard Error 0.1327
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth

Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlGingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth0.877 Units on a scaleStandard Deviation 0.88
B - Postive ControlGingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth0.53 Units on a scaleStandard Deviation 0.76
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth

Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlGingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth0.77 Units on a scaleStandard Deviation 0.8
B - Postive ControlGingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth0.51 Units on a scaleStandard Deviation 0.67
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants

Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlGingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants0.81 Units on a scaleStandard Deviation 0.9
B - Postive ControlGingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants0.45 Units on a scaleStandard Deviation 0.69
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants

Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlGingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants0.65 Units on a scaleStandard Deviation 0.78
B - Postive ControlGingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants0.48 Units on a scaleStandard Deviation 0.68
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Löe-Silness Gingival Index Score (GI)- Dental Implants

Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlLöe-Silness Gingival Index Score (GI)- Dental Implants1.24 units on a scaleStandard Deviation 0.81
B - Postive ControlLöe-Silness Gingival Index Score (GI)- Dental Implants0.99 units on a scaleStandard Deviation 0.73
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Löe-Silness Gingival Index Score (GI)- Dental Implants

Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlLöe-Silness Gingival Index Score (GI)- Dental Implants1.27 units on a scaleStandard Deviation 0.67
B - Postive ControlLöe-Silness Gingival Index Score (GI)- Dental Implants1.12 units on a scaleStandard Deviation 0.63
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Löe-Silness Gingival Index Score (GI) - Natural Teeth

Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlLöe-Silness Gingival Index Score (GI) - Natural Teeth1.29 units on a scaleStandard Deviation 0.79
B - Postive ControlLöe-Silness Gingival Index Score (GI) - Natural Teeth1.01 units on a scaleStandard Deviation 0.8
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Löe-Silness Gingival Index Score (GI) - Natural Teeth

Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlLöe-Silness Gingival Index Score (GI) - Natural Teeth1.3 units on a scaleStandard Deviation 0.73
B - Postive ControlLöe-Silness Gingival Index Score (GI) - Natural Teeth1.17 units on a scaleStandard Deviation 0.61
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Mombelli Plaque Index (mPI) for Dental Implants

Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlMombelli Plaque Index (mPI) for Dental Implants1.71 units on a scaleStandard Deviation 0.56
B - Postive ControlMombelli Plaque Index (mPI) for Dental Implants1.45 units on a scaleStandard Deviation 0.53
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Mombelli Plaque Index (mPI) for Dental Implants

Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlMombelli Plaque Index (mPI) for Dental Implants1.62 units on a scaleStandard Deviation 0.63
B - Postive ControlMombelli Plaque Index (mPI) for Dental Implants1.35 units on a scaleStandard Deviation 0.48
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Mombelli Plaque Index (mPI) for Natural Teeth

Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlMombelli Plaque Index (mPI) for Natural Teeth1.96 units on a scaleStandard Deviation 0.63
B - Postive ControlMombelli Plaque Index (mPI) for Natural Teeth1.82 units on a scaleStandard Deviation 0.62
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Mombelli Plaque Index (mPI) for Natural Teeth

Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
A - Fluoride ControlMombelli Plaque Index (mPI) for Natural Teeth2.05 units on a scaleStandard Deviation 0.59
B - Postive ControlMombelli Plaque Index (mPI) for Natural Teeth1.73 units on a scaleStandard Deviation 0.68
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Neissera sp. (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlNeissera sp. (DNA Probe Analysis) - Dental Implants4.585 Log cfu (colony forming units)Standard Error 0.1546
B - Postive ControlNeissera sp. (DNA Probe Analysis) - Dental Implants4.415 Log cfu (colony forming units)Standard Error 0.2199
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Neissera sp. (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlNeissera sp. (DNA Probe Analysis) - Dental Implants4.405 Log cfu (colony forming units)Standard Error 0.1151
B - Postive ControlNeissera sp. (DNA Probe Analysis) - Dental Implants3.955 Log cfu (colony forming units)Standard Error 0.1193
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Neissera sp. (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlNeissera sp. (DNA Probe Analysis) - Natural Teeth4.638 Log cfu (colony forming units)Standard Error 0.1203
B - Postive ControlNeissera sp. (DNA Probe Analysis) - Natural Teeth4.508 Log cfu (colony forming units)Standard Error 0.1336
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Neissera sp. (DNA Probe Analysis) Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlNeissera sp. (DNA Probe Analysis) Natural Teeth4.702 Log cfu (colony forming units)Standard Error 0.1301
B - Postive ControlNeissera sp. (DNA Probe Analysis) Natural Teeth4.658 Log cfu (colony forming units)Standard Error 0.1604
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Gingivalis (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Gingivalis (DNA Probe Analysis) - Dental Implants5.784 Log cfu (colony forming units)Standard Error 0.1533
B - Postive ControlP.Gingivalis (DNA Probe Analysis) - Dental Implants4.926 Log cfu (colony forming units)Standard Error 0.1789
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Gingivalis (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Gingivalis (DNA Probe Analysis) - Dental Implants5.562 Log cfu (colony forming units)Standard Error 0.1995
B - Postive ControlP.Gingivalis (DNA Probe Analysis) - Dental Implants4.642 Log cfu (colony forming units)Standard Error 0.2578
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Gingivalis (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Gingivalis (DNA Probe Analysis) - Natural Teeth6.166 Log cfu (colony forming units)Standard Error 0.1438
B - Postive ControlP.Gingivalis (DNA Probe Analysis) - Natural Teeth5.183 Log cfu (colony forming units)Standard Error 0.1705
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Gingivalis (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Gingivalis (DNA Probe Analysis) - Natural Teeth6.071 Log cfu (colony forming units)Standard Error 0.1675
B - Postive ControlP.Gingivalis (DNA Probe Analysis) - Natural Teeth4.951 Log cfu (colony forming units)Standard Error 0.2125
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Intermedia (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Intermedia (DNA Probe Analysis) - Dental Implants4.544 Log cfu (colony forming units)Standard Error 0.1555
B - Postive ControlP.Intermedia (DNA Probe Analysis) - Dental Implants3.853 Log cfu (colony forming units)Standard Error 0.2115
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Intermedia (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Intermedia (DNA Probe Analysis) - Dental Implants4.329 Log cfu (colony forming units)Standard Error 0.1617
B - Postive ControlP.Intermedia (DNA Probe Analysis) - Dental Implants3.803 Log cfu (colony forming units)Standard Error 0.3178
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Intermedia (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Intermedia (DNA Probe Analysis) - Natural Teeth5.091 Log cfu (colony forming units)Standard Error 0.1526
B - Postive ControlP.Intermedia (DNA Probe Analysis) - Natural Teeth3.853 Log cfu (colony forming units)Standard Error 0.1824
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Intermedia (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Intermedia (DNA Probe Analysis) - Natural Teeth5.007 Log cfu (colony forming units)Standard Error 0.1499
B - Postive ControlP.Intermedia (DNA Probe Analysis) - Natural Teeth3.803 Log cfu (colony forming units)Standard Error 0.1875
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Melaninogenica (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Melaninogenica (DNA Probe Analysis) - Dental Implants4.406 Log cfu (colony forming units)Standard Error 0.0982
B - Postive ControlP.Melaninogenica (DNA Probe Analysis) - Dental Implants3.363 Log cfu (colony forming units)Standard Error 0.11309
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Melaninogenica (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Melaninogenica (DNA Probe Analysis) - Dental Implants4.387 Log cfu (colony forming units)Standard Error 0.1131
B - Postive ControlP.Melaninogenica (DNA Probe Analysis) - Dental Implants3.155 Log cfu (colony forming units)Standard Error 0.1303
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Melaninogenica (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Melaninogenica (DNA Probe Analysis) - Natural Teeth5.062 Log cfu (colony forming units)Standard Error 0.1141
B - Postive ControlP.Melaninogenica (DNA Probe Analysis) - Natural Teeth3.691 Log cfu (colony forming units)Standard Error 0.1252
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

P.Melaninogenica (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlP.Melaninogenica (DNA Probe Analysis) - Natural Teeth5.066 Log cfu (colony forming units)Standard Error 0.1067
B - Postive ControlP.Melaninogenica (DNA Probe Analysis) - Natural Teeth3.935 Log cfu (colony forming units)Standard Error 0.1171
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlSolobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants5.767 Log cfu (colony forming units)Standard Error 0.0346
B - Postive ControlSolobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants4.701 Log cfu (colony forming units)Standard Error 0.02777
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlSolobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants5.046 Log cfu (colony forming units)Standard Error 0.3545
B - Postive ControlSolobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants3.899 Log cfu (colony forming units)Standard Error 0.4863
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlSolobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth6.511 Log cfu (colony forming units)Standard Error 0.1553
B - Postive ControlSolobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth5.237 Log cfu (colony forming units)Standard Error 0.1608
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlSolobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth6.081 Log cfu (colony forming units)Standard Error 0.2425
B - Postive ControlSolobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth4.487 Log cfu (colony forming units)Standard Error 0.2476
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Streptococci (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlStreptococci (DNA Probe Analysis) - Dental Implants4.665 Log cfu (colony forming units)Standard Error 0.1431
B - Postive ControlStreptococci (DNA Probe Analysis) - Dental Implants2.404 Log cfu (colony forming units)Standard Error 0.1503
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Streptococci (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlStreptococci (DNA Probe Analysis) - Dental Implants5 Log cfu (colony forming units)Standard Error 0.1317
B - Postive ControlStreptococci (DNA Probe Analysis) - Dental Implants3.263 Log cfu (colony forming units)Standard Error 0.1383
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Streptococci (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlStreptococci (DNA Probe Analysis) - Natural Teeth5.995 Log cfu (colony forming units)Standard Error 0.1175
B - Postive ControlStreptococci (DNA Probe Analysis) - Natural Teeth4.495 Log cfu (colony forming units)Standard Error 0.1234
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Streptococci (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlStreptococci (DNA Probe Analysis) - Natural Teeth5.867 Log cfu (colony forming units)Standard Error 0.1195
B - Postive ControlStreptococci (DNA Probe Analysis) - Natural Teeth4.109 Log cfu (colony forming units)Standard Error 0.1255
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

T.Forsythia (DNA Probe Analysis)- Dental Implants

14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlT.Forsythia (DNA Probe Analysis)- Dental Implants6.08 Log cfu (colony forming units)Standard Error 0.1691
B - Postive ControlT.Forsythia (DNA Probe Analysis)- Dental Implants4.633 Log cfu (colony forming units)Standard Error 0.2153
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

T.Forsythia (DNA Probe Analysis)- Dental Implants

14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlT.Forsythia (DNA Probe Analysis)- Dental Implants6.19 Log cfu (colony forming units)Standard Error 0.1637
B - Postive ControlT.Forsythia (DNA Probe Analysis)- Dental Implants4.628 Log cfu (colony forming units)Standard Error 0.1831
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

T.Forsythia (DNA Probe Analysis)- Natural Teeth

14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlT.Forsythia (DNA Probe Analysis)- Natural Teeth6.408 Log cfu (colony forming units)Standard Error 0.1348
B - Postive ControlT.Forsythia (DNA Probe Analysis)- Natural Teeth5.143 Log cfu (colony forming units)Standard Error 0.1474
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

T.Forsythia (DNA Probe Analysis)-Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlT.Forsythia (DNA Probe Analysis)-Natural Teeth6.286 Log cfu (colony forming units)Standard Error 0.1628
B - Postive ControlT.Forsythia (DNA Probe Analysis)-Natural Teeth4.926 Log cfu (colony forming units)Standard Error 0.182
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Veillonella sp.(DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlVeillonella sp.(DNA Probe Analysis) - Dental Implants5.472 Log cfu (colony forming units)Standard Error 0.1408
B - Postive ControlVeillonella sp.(DNA Probe Analysis) - Dental Implants4.485 Log cfu (colony forming units)Standard Error 0.1494
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Veillonella sp.(DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlVeillonella sp.(DNA Probe Analysis) - Dental Implants5.364 Log cfu (colony forming units)Standard Error 0.1425
B - Postive ControlVeillonella sp.(DNA Probe Analysis) - Dental Implants4.186 Log cfu (colony forming units)Standard Error 0.1511
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Veillonella sp.(DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlVeillonella sp.(DNA Probe Analysis) - Natural Teeth5.82 Log cfu (colony forming units)Standard Error 0.1185
B - Postive ControlVeillonella sp.(DNA Probe Analysis) - Natural Teeth4.927 Log cfu (colony forming units)Standard Error 0.1245
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary

Veillonella sp.(DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - Fluoride ControlVeillonella sp.(DNA Probe Analysis) - Natural Teeth5.746 Log cfu (colony forming units)Standard Error 0.1282
B - Postive ControlVeillonella sp.(DNA Probe Analysis) - Natural Teeth4.563 Log cfu (colony forming units)Standard Error 0.1346
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026