Compare Anti-inflammatory Dentifrices

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00762528

Enrollment

Registered

2008-09-30

Start date

2009-02-28

Completion date

2010-02-28

Last updated

2015-09-10

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

Conditions

Gingivitis

Brief summary

Plaque induced gingivitis

Interventions

DRUGTriclosan/Copolymer/fluoride toothpaste

Twice daily usage

DRUGSodium monofluorophosphate toothpaste

Twice daily usage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects must be adult males or females 18 to 60 years old * Subjects must be able and willing to follow study procedures and instructions * Subjects must have read, understood and signed an informed consent form * Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination * Subjects must present with at least 20 teeth in the functional dentition, excluding third molars * Each subject must have at least four teeth with probing depths of 4-5 mm and at least 30% of sites bleeding to gentle probing

Exclusion criteria

* Subjects who have chronically used (i.e., two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment * Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity * Subjects with periodontitis as indicated by periodontal pocketing 6 mm at screening * Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis * Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment * Subjects with orthodontic appliances or removable partial dentures * Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment * Subjects who currently smoke or who report using tobacco products within one year of screening. * Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment * Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis * Female subjects who report being pregnant or lactating, or female subjects who are of childbearing potential and who report not using hormonal or barrier methods of birth control (oral or parenteral contraceptives, diaphragm plus spermicide, condoms) * Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination. * Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis * Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator * Medical condition which precludes not eating/drinking for approximately 8 hours.

Design outcomes

Primary

Measure	Time frame	Description
8-iso-prostaglandinF2α (8-iso-PGF2α)	29 days	Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Interleukin-6 (IL-6)	29 days	Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Nuclear Factor Kappa B Ligand (RANK-L)	29 days	Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Gingival Index (GI)	29 days	Gingival Index(GI)recorded on scale of 0-3 detailed below: 0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed
Prostaglandin E2 (PGE2)	29 days	Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Interleukin - 1 Beta (IL-ß)	29 days	Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

Secondary

Measure	Time frame	Description
Bleeding on Probing (BOP)	29 days	Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.
Dental Plaque Index (PI)	29 days	measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.

Countries

United States

Participant flow

Recruitment details

subject recruitment will be completed by the PI at the clinical site.

Pre-assignment details

Subjects are screened for plaque, bleeding and gingivitis scores before being assigned to any Study Treatment. Study Treatment randomization is balanced across the two treatment groups and is accomplished by stratification of subjects by gender (male & female) and baseline gingivitis (GI) scores.

Participants by arm

Arm	Count
Total Toothpaste Triclosan/Copolymer/fluoride toothpaste	24
Fluoride Toothpaste sodium monofluorophosphate toothpaste	25
Total	49

Baseline characteristics

Characteristic	Fluoride Toothpaste	Total Toothpaste	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	25 Participants	24 Participants	49 Participants
Age, Continuous	29.2 years STANDARD_DEVIATION 9.6	27.5 years STANDARD_DEVIATION 10.7	28.4 years STANDARD_DEVIATION 10.1
Region of Enrollment United States	25 participants	24 participants	49 participants
Sex: Female, Male Female	12 Participants	12 Participants	24 Participants
Sex: Female, Male Male	13 Participants	12 Participants	25 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 24	6 / 25
serious Total, serious adverse events	0 / 24	0 / 25

Outcome results

Primary

8-iso-prostaglandinF2α (8-iso-PGF2α)

Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

Time frame: 29 days

Arm	Measure	Value (LOG_MEAN)	Dispersion
Total Toothpaste	8-iso-prostaglandinF2α (8-iso-PGF2α)	14.2 pg/µl	Standard Deviation 3.8
Fluoride Toothpaste	8-iso-prostaglandinF2α (8-iso-PGF2α)	15.2 pg/µl	Standard Deviation 1.6