Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluorides

Criteria

Inclusion Criteria:

1. Demonstrates understanding of the study.

2. Aged 18 to 85 years.

3. Understands and is willing, able and likely to comply with all study procedures and restrictions.

4. Has good general health (in the opinion of the investigator or medically qualified designee).

5. Currently living in the Indianapolis, Indiana area.

6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.

7. Have no current active caries or periodontal disease and all restorations in a good state of repair.

8. Have a salivary flow rate in the range of normal values.

Exclusion Criteria:

1. Pregnant or breast feeding women.

2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.

3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.

4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.

5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.

6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment.

7. Recent history (within the last year) of alcohol or other substance abuse.