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Phase 3 N=15 Randomized Double-blind Treatment

Train New Examiners Via Modified Gingival Margin Plaque

Dental Plaque

Enrolled (actual)
15
Serious AEs
Results posted
Nov 2008
Primary outcome: Primary: Mean Gingival Plaque Units — 13.38; 14.29 Units on a scale — p=0.05

Study Design & Population

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Gingival Plaque Units
13.38; 14.29 0.05

Summary

The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.

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 for 24-hrs.after initial appointment.
  • 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

  • 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).
  • 2 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 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.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00758563). 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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