Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Dental Caries

Treatments: Drug: Sodium fluoride / silica and carbopol, 1.5g; Drug: Sodium fluoride / silica and carbopol, 0.5g; Other: Fluoride free dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563172

T3158587

Details and patient eligibility

About

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).

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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65 participants in 5 patient groups

Experimental dentifrice 0.5g, 45 seconds brushing group

Experimental group

Description:

Participants brush twice a daily for 45 seconds with experimental dentifrice.

Treatment:

Drug: Sodium fluoride / silica and carbopol, 0.5g

Other: Fluoride free dentifrice

Experimental dentifrice 1.5g, 45 seconds brushing group

Experimental group

Description:

Participants brush twice a daily for 45 seconds with experimental dentifrice.

Treatment:

Other: Fluoride free dentifrice

Drug: Sodium fluoride / silica and carbopol, 1.5g

Drug: Sodium fluoride / silica and carbopol, 1.5g

Experimental dentifrice 0.5g, 2 minutes brushing group

Experimental group

Description:

Participants brush twice a daily for 2 minutes with experimental dentifrice.

Treatment:

Drug: Sodium fluoride / silica and carbopol, 0.5g

Other: Fluoride free dentifrice

Experimental dentifrice 1.5g, 2 minutes brushing group

Experimental group

Description:

Participants brush twice a daily for 2 minutes with experimental dentifrice.

Treatment:

Other: Fluoride free dentifrice

Drug: Sodium fluoride / silica and carbopol, 1.5g

Drug: Sodium fluoride / silica and carbopol, 1.5g

Contol group

Active Comparator group

Description:

Participants brush twice a daily for 2 minutes with controll dentifrice.

Treatment:

Other: Fluoride free dentifrice

Drug: Sodium fluoride / silica and carbopol, 1.5g

Drug: Sodium fluoride / silica and carbopol, 1.5g