Enamel Remineralization Potential of Dentifrices in Situ

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Dental Caries

Treatments: Drug: NaMFP; Drug: SnF; Drug: NaF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01128946

T3500690

Details and patient eligibility

About

This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.

Enrollment: 83 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
• No current active caries or periodontal disease that may compromise the study or health of the subject.
• All restorations in a good state of repair
• Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
• Willing to have their denture modified to accomodate enamel test specimens
• Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
• Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.

Exclusion criteria

• Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
• Current active caries or periodontal disease that may compromise the study or health of the subject.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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83 participants in 4 patient groups

Fluoride Toothpaste 1

Experimental group

Description:

Fluoride toothpaste containing sodium fluoride (NaF)

Treatment:

Drug: NaF

Fluoride Toothpaste 2

Experimental group

Description:

Fluoride toothpaste containing stannous fluoride (SnF) and NaF.

Treatment:

Drug: SnF

Drug: NaF

Fluoride Toothpaste 3

Experimental group

Description:

Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.

Treatment:

Drug: NaF

Drug: NaMFP

Reference Dentifrice

Active Comparator group

Description:

Low fluoride toothpaste containing NaF

Treatment:

Drug: NaF