Training and Calibration of Dental Examiners
This study has been completed.
Sponsor:
Colgate Palmolive
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00765167
First received: September 23, 2008
Last updated: October 2, 2008
Last verified: October 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Training and calibration of dental examiners
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Plaque |
Drug: Fluoride Drug: Triclosan Drug: Chlorhexidine gluconate |
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: | Training and Calibration of Dental Examiners |
Resource links provided by NLM:
Drug Information available for:
Chlorhexidine
Hexachlorophene
Sodium gluconate
Triclosan
Manganese gluconate
Fluorine
Fluoride
Chlorhexidine gluconate
Hibiclens
U.S. FDA Resources
Further study details as provided by Colgate Palmolive:
Primary Outcome Measures:
- Dental plaque [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | November 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 |
Drug: Fluoride
Brush half mouth twice daily for four days
|
| Active Comparator: B |
Drug: Triclosan
Brush half mouth daily for four days
Drug: Fluoride
Brush half mouth daily for four days
|
| Active Comparator: C |
Drug: Chlorhexidine gluconate
Mouth rinsing with 15 ml for 30 seconds twice a day for four days
|
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
- Minimum of 20 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.
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 or heavy dental tartar (calculus).
- 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 affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).
- 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.
- Allergy to chlorhexidine
- Use of tobacco products
- Subjects who must receive dental treatment during the study dates.
- Current use of Antibiotics for any purpose.
- Presence of an orthodontic appliance.
- History of allergy to common dentifrice ingredients.
- 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: | NCT00765167 History of Changes |
| Other Study ID Numbers: | ATO-2007-PLA-01-RR |
| Study First Received: | September 23, 2008 |
| Last Updated: | October 2, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dental Plaque Dental Deposits Tooth Diseases Stomatognathic Diseases Chlorhexidine Chlorhexidine gluconate Triclosan Fluorides Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Disinfectants Dermatologic Agents Cariostatic Agents Protective Agents Physiological Effects of Drugs Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 22, 2013