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Phase 3 N=23 Randomized Double-blind Treatment

Clinical Study to Evaluate Dental Plaque

Gingival Diseases

Enrolled (actual)
23
Serious AEs
Results posted
Nov 2008
Primary outcome: Primary: Dental Plaque Index — 2.48; 2.42 Units on a scale — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Triclosan/Fluoride (Drug); Fluoride/triclosan (Drug)
Age
Adult · 20+ yrs
Sex
All
Sponsor
Colgate Palmolive
Primary completion
Jul 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Dental Plaque Index
2.48; 2.42 0.05

Summary

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

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
  • 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 which interferes with plaque scoring
  • History of allergy to common toothpaste ingredients
  • History of allergy to arginine (amino acid)
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00758290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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