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Compare the Clinical Efficacy of Prototype Toothpastes

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ClinicalTrials.gov Identifier: NCT00926029
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : June 23, 2009
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Fluoride Drug: Triclosan, fluoride Other: Metal salt Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 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 : January 2008
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoride
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Fluoride control -A
Winterfresh Gel
Drug: Fluoride
Brush twice daily
Other Name: Colgate Winterfresh Gel
Active Comparator: Triclosan/Fluoride - B
Positive control (Total toothpaste)
Drug: Triclosan, fluoride
Brush twice daily
Other Name: Colgate Total toothpaste
Experimental: Triclosan/fluoride/metal salt- C
test toothpaste
Other: Metal salt
Brush twice daily
Other Name: New toothpaste formula being evaluated.

Primary Outcome Measures :
  1. Plaque Index [ Time Frame: 6 weeks ]
    Plaque Index score 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)

  2. Gingivitis Index [ Time Frame: 6 Weeks ]
    Gingivitis score- 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 20 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.

Exclusion Criteria:

  • Subject 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.
  • 5 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 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.
  • Presence of an orthodontic appliance.
  • History of allergy to common dentifrice ingredients.
  • History of allergy to zinc.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

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): NCT00926029

United States, New Jersey
Concordia Clinical Research
Cedar Knolls, New Jersey, United States, 07927
Sponsors and Collaborators
Colgate Palmolive
Principal Investigator: Salim A Nathoo, DDS

Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00926029     History of Changes
Other Study ID Numbers: CRO-2007-GIN-06-RR
First Posted: June 23, 2009    Key Record Dates
Results First Posted: June 23, 2009
Last Update Posted: February 17, 2012
Last Verified: June 2011

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Sodium Fluoride
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