Compare the Clinical Efficacy of Prototype Toothpastes

This study has been completed.
Information provided by (Responsible Party):
Colgate Palmolive Identifier:
First received: September 26, 2008
Last updated: February 16, 2012
Last verified: June 2011

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

Condition Intervention Phase
Dental Plaque
Drug: Fluoride
Drug: Triclosan, fluoride
Other: Metal salt
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:
  • Plaque Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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)

  • Gingivitis Index [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    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)

Enrollment: 98
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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 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).
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Colgate Palmolive Identifier: NCT00926029     History of Changes
Other Study ID Numbers: CRO-2007-GIN-06-RR
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: February 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth 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