Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01799226

Enrollment

Registered

2013-02-26

Start date

2013-03-31

Completion date

2013-12-31

Last updated

2016-01-13

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

Conditions

Gingivitis

Brief summary

This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model developed by Löe et al. Half of the participants will use Colgate Total® (which contains triclosan), while the other half will use a toothpaste which does not contain triclosan as the control.

Detailed description

This will be a double-blind. Subjects will be randomly assigned to the test or control dentifrice arm. Enrolled subjects will also be randomly assigned to either right or left side mandibular stent. During the induction phase (i.e., day 0 to day 21), participants are instructed to refrain from all hygiene procedures in the stent area. During this time period, participants evenly distributed 2mL of their assigned dentifrice into their stent, allowing it to come into contact with the areas of experimental gingivitis for two minutes twice daily while traditional tooth brushing was performed in the non-stent areas. Clinical measures, saliva, gingival crevicular fluid and plaque samples will be collected at days 0, 14, 21, and 35 study visits. A randomization chart will be used to identify which two sites (teeth and tooth surface) will be used at the specific study visit for collection of gingival crevicular fluid(GCF) and plaque.

Interventions

OTHERToothpaste without triclosan

this intervention will use a toothpaste without triclosan

OTHERTriclosan

this intervention will use Colgate Total which contains triclosan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Race - all * Gender - female or male * Age - 18 to 40 years old * Dentition - minimum of 20 permanent teeth * Probing Pocket Depth of 1-4mm in all sites * Mean Clinical Attachment Levels of 2mm on all teeth * Bleeding Upon Probing of greater than 30% at Day -14 Study Visit * Consent Form - read, understood, and signed * Study Procedures - willing to follow all study procedures * At Day 0 Study Visit, all subjects must have a BOP of less than 10%. Subjects not meeting the BOP study criteria will be asked to return in 2 weeks for a second assessment visit. Subjects who do not meet the inclusion criteria * BOP less than 10% at the second assessment visit will be exited from the * study

Exclusion criteria

* Medical History - a history of alcoholism or drug abuse * Diseases of the immune system * Medical condition that may affect outcome (neurologic or psychiatric disorders, systemic infection * Medications - chronic medications known to affect the periodontal status (calcium antagonists anticonvulsives, immunosuppressives, anti-inflammatory medications, phenytoin, Depo-Provera contraceptive injection users * New oral contraceptives users within 3 months of baseline or are planning on starting oral contraceptives during the study * Hypersensitivity - previous known reaction to or oral allergy to any ingredient in the study toothpaste * Antibiotics - antibiotic therapy within 3 months of baseline visit * antibiotic therapy needed for infective endocarditis prophylaxis or total joint replacement * Use of antiseptics - homecare regime using products to control dental plaque formation within 30 days prior to baseline visit * Smoking - current smokers, smokers who quit smoking less than one year ago, or a pack-year history of more than or equal to 10 (pack-years will be calculated by multiplying the number of years smoked by the average number of cigarette packs smoked per day) * Continine - positive urine analysis results * Current Dental Treatment - orthodontic or periodontal treatment * Untreated Dental Treatment - untreated carious lesions * Defective restorations which could exacerbate during a period of oral hygiene abstinence * Pregnant or women breast-feeding

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35	Baseline to 35 Days	Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.

Secondary

Measure	Time frame	Description
Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35	Baseline to 35 Days	Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.

Other

Measure	Time frame	Description
Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.	Baseline to 35 Days	Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).
Plaque Samples Will be Collected for Bacterial Species Detection.	Baseline to 35 Days	Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.
Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.	Baseline to 35 Days	A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.

Countries

United States

Participant flow

Pre-assignment details

Initially 15 participants were sought for each arm, but when two were withdrawn from the control arm, two more participants were recruited and randomized, one to each arm. So total start on each arm was 16. The Disqualification noted below for one participant was because s/he no longer met inclusion criteria as of day 14.

Participants by arm

Arm	Count
Control Arm Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).	16
Test Arm Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).	16
Total	32

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Disqualified at Day 14	1	0
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Control Arm	Test Arm	Total
Age, Customized Age	27.07 years	26.06 years	26.57 years
Bleeding on probing ≤ 10%	0.065 Percent of sites bleeding on probing	0.063 Percent of sites bleeding on probing	0.064 Percent of sites bleeding on probing
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants	15 Participants	28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants	2 Participants	6 Participants
Race (NIH/OMB) White	9 Participants	11 Participants	20 Participants
Region of Enrollment United States	16 participants	16 participants	32 participants
Sex: Female, Male Female	14 Participants	9 Participants	23 Participants
Sex: Female, Male Male	2 Participants	7 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	4 / 16	8 / 16
serious Total, serious adverse events	0 / 16	0 / 16

Outcome results

Primary

Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35

Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.