Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by GlaxoSmithKline.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00708305
First received: July 1, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

This study is to evaluate the amount of fluoride in plaque fluid after brushing iwth fluoride dentifrices


Condition Intervention Phase
Healthy Volunteers
Drug: fluoride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Area under the fluoride concentration in plaque fluid by time curve between zero and four hours following single use.

Secondary Outcome Measures:
  • Between-treatment comparisons with respect to area under the fluoride concentration in plaque fluid by time curve between zero and four hours. Change in fluoride concentration in plaque fluid from baseline.

Estimated Enrollment: 53
Study Start Date: June 2008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708305

Locations
United States, Indiana
GSK Clinical Trials Call Centre Recruiting
Indianapolis, Indiana, United States, 46202
Contact: GSK Clinical Trials Call center     877-379-3718        
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, DDS GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00708305     History of Changes
Other Study ID Numbers: T3508570
Study First Received: July 1, 2008
Last Updated: July 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
fluoride
plaque fluid
toothpaste

Additional relevant MeSH terms:
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013