Clinical Study to Evaluate Dental Plaque
Completed · Phase 3
Conditions studied: Gingival Diseases
In brief
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.
Key facts
- Study ID
- NCT00758290
- Run by
- Colgate Palmolive
- People needed
- 23
- Starts
- 2008-05-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2008-11-25
Who can join
Age: 20 and older, up to 51. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female volunteers at least 20 - 51 years of age
- Good general health
- Must sign informed consent form
- Minimum of 15 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
You may not qualify if…
- 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)
- 5 or more decayed untreated dental sites at screening (cavities)
- 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 are currently affecting salivary function
- 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
- 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 which interferes with plaque scoring
- History of allergy to common toothpaste ingredients
- History of allergy to arginine (amino acid)
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Where it is running
- Bluestone Center for Clinical Research, NYU College of Dentistry — New York, New York, United States
Full record on ClinicalTrials.gov
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