Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluorides; Listerine; Sodium Fluoride

Criteria

Inclusion Criteria:

General and Dental Health

• Good general and dental health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination

• Have no current active caries or periodontal disease that may compromise the study or the health of the subjects

• Residency: Currently living in the Indianapolis, Indiana area

Dentures:

• Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 mm x 7 mm)

• Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods

• All restorations in a good state of repair

• Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute)

Exclusion Criteria:

• Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use during the study treatment periods

• Study Scale Use: Subjects unable to measure product weights accurately using the assigned study scale as determined by the study staff (as demonstrated on or before Visit 4)

• A member of the site study staff who is directly working on the project or living in that staff's household

• Any employee of any toothpaste manufacturer or their spouse or family member