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Compare the Clinical Efficacy of Prototype Toothpastes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00926029
First received: September 26, 2008
Last updated: February 16, 2012
Last verified: June 2011
History of Changes
  Purpose

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:

MedlinePlus related topics: Dietary Sodium
U.S. FDA Resources

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.

  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 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 ClinicalTrials.gov identifier: NCT00926029

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

No publications provided

Responsible Party: Colgate Palmolive
ClinicalTrials.gov 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
Fluorides
Triclosan
Hexachlorophene
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 23, 2013