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Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes - NCT00708305-46202(Clinical Trial 229649)



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City:  Indianapolis
State:  
IN
Zip Code: 46202
Conditions: Healthy Volunteers
Purpose: This study is to evaluate the amount of fluoride in plaque fluid after brushing iwth fluoride dentifrices
Study summary:
Criteria: Inclusion Criteria: 1. Age Age 18 through 65 years. 2. General Health Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination, specifically including diabetes or hypoglycemia. 3. Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 5. Oral 1. Currently living in the Indianapolis, Indiana area and not taking fluoride supplements. 2. Have a normal stimulated (= 0.8 ml/min) and unstimulated (= 0.2 ml/min) salivary flow rate. 3. Have a full complement of natural teeth with the exception of third molars and teeth extracted for orthodontic reasons. Subjects' natural teeth must have at least one surface free of restoration in each interproximal embrasure. 4. Produce at least 6mg of plaque at Screening Visit 2. Exclusion Criteria: 1. Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required. 2. Breast-feeding Women who are breast-feeding. 3. Medical History Current or relevant history of any serious, severe or unstable physical or psychiatric illness that would make the subject unlikely to fully complete the study or any that increases the risk to the subject. 4. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 5. Clinical Study/Experimental Medication Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit 1 at the start of the study with the exception of those participating in GSKCH study Z3170476. 6. Medication 1. Currently taking antibiotics or have taken antibiotics in the two weeks prior to any treatment visit or during the study. 2. Has a medical condition that would require prophylactic antibiotics prior to a dental cleaning. 7. Dental 1. Current active caries or moderate to severe periodontal disease that may compromise the health of the subjects or the study. 2. Current use of chlorhexidine mouthrinse. 8. Personnel An employee of the sponsor or the study site who is directly involved in the conduct of the study.
Study is available at: GSK Clinical Trials Call Centre
Indianapolis, IN 46202
United States

Primary Contact:
GSK Clinical Trials Call center
Phone: 877-379-3718
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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