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Clinical Trials/NCT00758290
NCT00758290
Completed
Phase 3

Clinical Study to Evaluate Dental Plaque

Colgate Palmolive1 site in 1 country23 target enrollmentMay 2008

Overview

Phase
Phase 3
Intervention
Triclosan/Fluoride
Conditions
Gingival Diseases
Sponsor
Colgate Palmolive
Enrollment
23
Locations
1
Primary Endpoint
Dental Plaque Index
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
July 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Male or female volunteers at least 20 - 51 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 15 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

  • 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 or heavy dental tartar (calculus)
  • 5 or more decayed untreated dental sites at screening (cavities)
  • 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 affecting salivary function
  • 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

Arms & Interventions

A

Intervention: Triclosan/Fluoride

B

Intervention: Fluoride/triclosan

Outcomes

Primary Outcomes

Dental Plaque Index

Time Frame: 4 Day

Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque

Study Sites (1)

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