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Compare the Clinical Efficacy of Prototype Toothpastes.

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ClinicalTrials.gov Identifier: NCT00761930
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : October 20, 2010
Last Update Posted : August 15, 2013
Sponsor:
Information provided by:
Colgate Palmolive

Study Description
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Brief Summary:
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Condition or disease Intervention/treatment Phase
Gingival Diseases Drug: Fluoride Drug: Triclosan and fluoride Drug: Herbal Ingredient and fluoride Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Compare the Clinical Efficacy of Prototype Toothpastes.
Study Start Date : March 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
Drug Information available for: Fluoride

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Dental Plaque [ Time Frame: 6 weeks ]
    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.

  2. Gingivitis Score [ Time Frame: 6 weeks ]

    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.


  3. Bleeding Index (EIBI) [ Time Frame: 6 weeks ]
    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.


Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: September 30, 2008    Key Record Dates
Results First Posted: October 20, 2010
Last Update Posted: August 15, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Triclosan
Listerine
Cariostatic Agents
 Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents