Compare the Clinical Efficacy of Prototype Toothpastes.

This study has been completed.
Information provided by:
Colgate Palmolive Identifier:
First received: September 26, 2008
Last updated: August 8, 2013
Last verified: August 2013

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Condition Intervention Phase
Gingival Diseases
Drug: Fluoride
Drug: Triclosan and fluoride
Drug: Herbal Ingredient and fluoride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Compare the Clinical Efficacy of Prototype Toothpastes.

Resource links provided by NLM:

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Dental Plaque [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Quigley Hein Method: 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. Plaque score= sum of all scores divided by the number of sites (teeth) scored.

  • Gingivitis Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Gingivitis score (GI)= 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 scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.

  • Bleeding Index (EIBI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.

Enrollment: 103
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
commercially available Fluoride toothpaste
Drug: Fluoride
Brush twice daily
Other Name: Colgate Great Regular Flavor toothpaste
Active Comparator: B
fluoride/triclosan/copolymer toothpaste
Drug: Triclosan and fluoride
Brush twice daily
Other Name: Colgate Total toothpaste
Experimental: C
fluoride/herbal toothpaste
Drug: Herbal Ingredient and fluoride
Brush twice daily


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or female volunteers 18-65 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
  • 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.
  • Dental Selection Criteria: Average full mouth GI score should be in the range of
  • - 2.0. heavy plaque formers should be avoided. Target a full mouth PI
  • (Quigley-Hein) to be in the range of 1.5-3.0
  • If of child bearing potential and on birth control (diaphragm, birth control pills,
  • Birth control implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Moderate or advanced periodontal disease
  • 2 or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that are currently affect salivary flow.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 1 week prior to enrollment into this
  • study.
  • Use of tobacco products
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for any purpose.
  • History of allergy to common dentifrice ingredients
  • Presence of an orthodontic appliance which interferes with plaque scoring.
  • History of allergy to natural remedies, such as herbal ingredients
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  • Smoker
  Contacts and Locations
Please refer to this study by its identifier: NCT00761930

United States, New York
Eastman Dental Center - University of Rochester
Rochester, New York, United States, 14642-8315
Sponsors and Collaborators
Colgate Palmolive
Principal Investigator: Yanfang Ren, DDS
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive Identifier: NCT00761930     History of Changes
Other Study ID Numbers: CRO-2007-GIN-04-RR
Study First Received: September 26, 2008
Results First Received: August 19, 2010
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents processed this record on April 16, 2014