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Phase 3 N=103 Randomized Double-blind Treatment

Compare the Clinical Efficacy of Prototype Toothpastes.

Gingival Diseases

Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Dental Plaque — 2.273; 1.806; 2.041 Units on a scale — p=<0.05

Study Design & Population

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Dental Plaque
2.273; 1.806; 2.041 <0.05 sig
PRIMARY
Gingivitis Score
0.942; 0.722; 0.705 <0.05 sig
PRIMARY
Bleeding Index (EIBI)
0.325; 0.164; 0.141 <0.05 sig

Summary

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Eligibility Criteria

Inclusion Criteria

  • Male or female volunteers 18-65 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 16 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.
  • Dental Selection Criteria: Average full mouth GI score should be in the range of
  • - 2.0. heavy plaque formers should be avoided. Target a full mouth PI
  • (Quigley-Hein) to be in the range of 1.5-3.0
  • If of child bearing potential and on birth control (diaphragm, birth control pills,
  • Birth control implants, IUD (Intrauterine device), condoms)

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
  • 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 are currently 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.
  • History of allergy to common dentifrice ingredients
  • Presence of an orthodontic appliance which interferes with plaque scoring.
  • History of allergy to natural remedies, such as herbal ingredients
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  • Smoker
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00761930). 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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