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Phase 3 N=22 Randomized Single-blind Treatment

Efficacy of Salivary Bacteria and Post Brushing

Salivary Bacteria Levels

Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcome: Primary: CFU (Colony Forming Units) — 7.18; 6.94 number of colony forming units — 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
Dec 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
CFU (Colony Forming Units)
7.18; 6.94 0.05

Summary

Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing

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.
  • 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 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 (NCT00981825). 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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