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Compare Anti-inflammatory Dentifrices

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ClinicalTrials.gov Identifier: NCT00762528
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 3, 2012
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 30, 2008
Results First Submitted Date  ICMJE March 5, 2012
Results First Posted Date  ICMJE April 3, 2012
Last Update Posted Date September 10, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
  • Gingival Index (GI) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
  • Interleukin-6 (IL-6) [ Time Frame: 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) [ Time Frame: 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.
  • 8-iso-prostaglandinF2α (8-iso-PGF2α) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Gingival disease [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
  • Dental Plaque Index (PI) [ Time Frame: 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.
  • Bleeding on Probing (BOP) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Dental plaque [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare Anti-inflammatory Dentifrices
Official Title  ICMJE Compare Anti-inflammatory Dentifrices
Brief Summary Plaque induced gingivitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gingivitis
Intervention  ICMJE
  • Drug: Triclosan/Copolymer/fluoride toothpaste
    Twice daily usage
    Other Name: Toothpaste includes triclosan/fluoride/co-polymer (Total)
  • Drug: Sodium monofluorophosphate toothpaste
    Twice daily usage
    Other Name: fluoride only toothpaste
Study Arms  ICMJE
  • Active Comparator: Total Toothpaste
    Triclosan/Copolymer/fluoride toothpaste
    Intervention: Drug: Triclosan/Copolymer/fluoride toothpaste
  • Placebo Comparator: Fluoride toothpaste
    sodium monofluorophosphate toothpaste
    Intervention: Drug: Sodium monofluorophosphate toothpaste
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2010)
49
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2008)
48
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762528
Other Study ID Numbers  ICMJE CRO-1107-INF-ECU-FP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Colgate Palmolive
Study Sponsor  ICMJE Colgate Palmolive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sara G Grossi, DDS
PRS Account Colgate Palmolive
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP