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Phase 3 N=25 Randomized Double-blind Treatment

Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

Gingival Diseases

Enrolled (actual)
25
Serious AEs
Results posted
Aug 2009
Primary outcome: Primary: Plaque Index — 2.45; 2.22; 2.54; 2.56 Units on a scale — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Fluoride (Drug); Triclosan/Fluoride toothpaste (Drug); antibacterial plant extract (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Colgate Palmolive
Primary completion
Jan 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Plaque Index
2.45; 2.22; 2.54; 2.56 0.05

Summary

Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment

Eligibility Criteria

Inclusion Criteria

  • Male or female volunteers 18-65 years of age.
  • Good general health.
  • Must sign informed consent form.
  • Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
  • 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

  • Medical condition which requires pre-medication prior to dental procedures/visits.
  • Medical condition which precludes eating/drinking for 12 hrs.
  • History of allergy to common dentifrice ingredients.
  • Subjects unable or unwilling to sign the informed consent form.
  • Moderate or advanced periodontal disease.
  • Two 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 can currently affect salivary flow.
  • Current use of antibiotics.
  • 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 30 days 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.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00966953). 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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