Evaluate Clinical Research From Commerical Oral Care Products
This study has been completed.
Information provided by:
First received: September 23, 2008
Last updated: February 24, 2010
Last verified: November 2008
The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.
Drug: Chlorhexidine Gluconate
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Evaluate Clinical Research From Commerical Oral Care Products
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2008 (Final data collection date for primary outcome measure)
Placebo Comparator: A
Brush twice daily
Other Name: monofluorophosphate
Active Comparator: B
Half mouth toothbrushing twice daily for 4 days
- sodium fluoride
Active Comparator: C
Drug: Chlorhexidine Gluconate
Mouth rinsing twice a day for 4 days
Other Name: Chlorhexidine Gluconate oral rinse
The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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) requiring more than one visit of cleaning sessions
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759187
|Boston University School of Dental Medicine
|Boston, Massachusetts, United States, 02118 |
||Thomas Van Dyke, DDS
No publications provided
||William DeVizio/VP - Clinical Research, Colgate Palmolive
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 23, 2008
|Results First Received:
||October 16, 2008
||February 24, 2010
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Anti-Infective Agents, Local
Physiological Effects of Drugs
Fatty Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents