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Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762515
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : December 14, 2010
Last Update Posted : December 28, 2010
Information provided by:
Colgate Palmolive

Brief Summary:
The objective is to compare two commerical oral products for the treatment of gingivitis.

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Fluoride Drug: Triclosan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Study Start Date : February 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: A
commercially available Fluoride only toothpaste
Drug: Fluoride
Brush teeth two times daily for 6 weeks

Active Comparator: B
Commercially available triclosan/copolymer/fluoride toothpaste
Drug: Triclosan
Brush two times daily for 6 weeks

Drug: Fluoride
Brush two times daily for 6 weeks

Primary Outcome Measures :
  1. Control Established Plaque in Adults [ Time Frame: 6 weeks ]
    Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.

Secondary Outcome Measures :
  1. Control Gingivitis in Adults [ Time Frame: 6 weeks ]
    Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male or female volunteers 18-65 years of age
  2. Good general health
  3. Must sign informed consent form
  4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
  5. No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
  6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

Exclusion Criteria:

  1. Subjects unable or unwilling to sign the informed consent form.
  2. Medical condition which requires pre-medication prior to dental visits/procedures
  3. Moderate or advanced periodontal disease
  4. History of allergy to iodine
  5. History of thyroid disease
  6. History of diabetes
  7. 2 or more decayed untreated dental sites at screening.
  8. Other disease of the hard or soft oral tissues.
  9. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  10. Use of medications that are currently affect salivary flow.
  11. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  12. Pregnant or nursing women.
  13. Participation in any other clinical study within 1 week prior to enrollment into this study.
  14. Use of tobacco products
  15. Subjects who must receive dental treatment during the study dates.
  16. Current use of Antibiotics for any purpose.
  17. Presence of an orthodontic appliance.
  18. History of allergy to common dentifrice ingredients
  19. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  20. Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
  21. Smoker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00762515

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United States, Kentucky
University of Louisville, School of Dentistry
Louisville, Kentucky, United States, 40292
Sponsors and Collaborators
Colgate Palmolive
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Principal Investigator: Denis Kinane, BDS
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Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive Identifier: NCT00762515    
Other Study ID Numbers: CRO-2007-GIN-03-RR
First Posted: September 30, 2008    Key Record Dates
Results First Posted: December 14, 2010
Last Update Posted: December 28, 2010
Last Verified: December 2010
Additional relevant MeSH terms:
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Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents