Efficacy of Salivary Bacteria and Post Brushing
This study has been completed.
Sponsor:
Colgate Palmolive
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00981825
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
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Purpose
Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
| Condition | Intervention | Phase |
|---|---|---|
|
Salivary Bacteria Levels |
Drug: Fluoride Drug: Triclosan/Fluoride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Efficacy of Salivary Bacteria and Post Brushing |
Resource links provided by NLM:
Further study details as provided by Colgate Palmolive:
Primary Outcome Measures:
- CFU (Colony Forming Units) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Total number of salivary bacterial colony forming units (lower number = less colonies present)
| Enrollment: | 22 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
fluoride toothpaste control
|
Drug: Fluoride
Whole mouth brushing for 7 days
Other Name: fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
|
|
Active Comparator: B
triclosan/fluoride toothpaste
|
Drug: Triclosan/Fluoride
Brush whole mouth twice daily for 7 days
Other Name: triclosan/fluoride toothpaste (Colgate Total toothpaste)
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations
More Information
No publications provided
| Responsible Party: | William DeVizio/VP - Clinical Research, Colgate Palmolive |
| ClinicalTrials.gov Identifier: | NCT00981825 History of Changes |
| Other Study ID Numbers: | ER0-2007-SAL-01-GX |
| Study First Received: | September 26, 2008 |
| Results First Received: | September 26, 2008 |
| Last Updated: | June 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Fluorides Triclosan Hexachlorophene Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Fatty Acid Synthesis Inhibitors |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 18, 2013