Compare Anti-inflammatory Dentifrices

NCT00762528 | Completed Phase 4 Results

• 1 other identifier: CRO-1107-INF-ECU-FP
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Plaque induced gingivitis

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (6)

• Gingival Index (GI)

  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

  29 days

• Prostaglandin E2 (PGE2)

  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.

  29 days

• Interleukin - 1 Beta (IL-ß)

  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.

  29 days

• Interleukin-6 (IL-6)

  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.

  29 days

• Nuclear Factor Kappa B Ligand (RANK-L)

  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.

  29 days

• 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.

  29 days

Secondary Outcomes (2)

• Dental Plaque Index (PI)

  29 days

• Bleeding on Probing (BOP)

  29 days

Study Arms (2)

Total Toothpaste

ACTIVE COMPARATOR

Triclosan/Copolymer/fluoride toothpaste

Drug: Triclosan/Copolymer/fluoride toothpaste

Fluoride toothpaste

PLACEBO COMPARATOR

sodium monofluorophosphate toothpaste

Drug: Sodium monofluorophosphate toothpaste

Interventions

Triclosan/Copolymer/fluoride toothpaste DRUG

Twice daily usage

Also known as: Toothpaste includes triclosan/fluoride/co-polymer (Total)

Total Toothpaste

Sodium monofluorophosphate toothpaste DRUG

Twice daily usage

Also known as: fluoride only toothpaste

Fluoride toothpaste

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

East Carolina University, Brody School of Medicine

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Triclosan

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: William DeVizio, DMD
• Organization: Colgate Palmolive Company

william_Devizio@colpal.com

732-878-7901

Study Officials

• Sara G Grossi, DDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: September 10, 2015
• Results First Posted: April 3, 2012

Record last verified: 2015-08

Locations

US (1)