MedPath

Evaluating Commercial Anti-Plaque Products and Oral Rinse

Phase 2
Completed
Conditions
Dental Plaque
Interventions
Registration Number
NCT01014143
Lead Sponsor
Colgate Palmolive
Brief Summary

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Detailed Description

This clinical research study was to train new examiners for short term plaque clinical methodologies.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
Inclusion Criteria
  • Male or female volunteers at least 18 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
  • 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).
  • 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 are currently affect salivary function.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Allergy to chlorhexidine.
  • 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 pre-medication for dental treatment or for any other purpose.
  • Presence of an orthodontic appliance that interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Fluoride toothpasteFluorideNegative control
Triclosan/Fluoride toothpasteFluoride, triclosanpositive control toothpaste
Chlorhexidine Oral RinseChlorhexidine digluconatePositive Control mouthrinse
Primary Outcome Measures
NameTimeMethod
Plaque IndexFour days

Plaque 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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New Institutional Service Company

🇺🇸

Northfield, New Jersey, United States

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