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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 October 23, 2014
Anti-Infective Agents, Local
Fatty Acid Synthesis Inhibitors
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs