Phase 3
N=25
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Gingival Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00966953 ↗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
| Outcome | Result | p-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).
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.