Compare the Clinical Efficacy of Prototype Toothpastes.

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00761930
First received: September 26, 2008
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761930

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

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov 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
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Fluorides
Triclosan
Anti-Infective Agents
Anti-Infective Agents, Local
Antimetabolites
Cariostatic Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014