Phase 3
N=22
Efficacy of Salivary Bacteria and Post Brushing
Salivary Bacteria Levels
Bottom Line
View on ClinicalTrials.gov: NCT00981825 ↗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
| Outcome | Result | p-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)
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.