Status:
COMPLETED
Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Dental Caries
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF) containing toothpastes in prevention of dental caries. Change from baseline fluoride data at various time po...
Detailed Description
Topical fluorides in a wide variety of delivery systems have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that fluoride has its anti-caries effect ...
Eligibility Criteria
Inclusion
- Age:Age 18 through 65 years.
- 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.
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- 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.
- Oral: a) Currently living in the Indianapolis, Indiana area and not taking fluoride supplements. b) Have a normal stimulated (= 0.8 ml/min) and unstimulated (= 0.2 ml/min) salivary flow rate. c) Have a full complement of natural teeth with the exception of third molars and teeth extracted for orthodontic reasons. Participants natural teeth must have at least one surface free of restoration in each interproximal embrasure. d) Produce at least 6mg of plaque at Screening Visit 2.
Exclusion
- 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.
- Breast-feeding:Women who are breast-feeding.
- 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.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- 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.
- Medication: a) Currently taking antibiotics or have taken antibiotics in the two weeks prior to any treatment visit or during the study. b) Has a medical condition that would require prophylactic antibiotics prior to a dental cleaning.
- Dental: a) Current active caries or moderate to severe periodontal disease that may compromise the health of the participants or the study. b) Current use of chlorhexidine mouthrinse.
- Personnel: An employee of the sponsor or the study site who is directly involved in the conduct of the study.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00708305
Start Date
June 1 2008
End Date
October 1 2008
Last Update
January 1 2015
Active Locations (1)
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1
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202