The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Oral Hygiene

Treatments: Drug: Sodium fluoride (1426 ppm) + zinc base B; Drug: Sodium fluoride (1426 ppm) + zinc base A; Drug: Sodium fluoride (250 ppm); Drug: Sodium fluoride (1426 ppm); Drug: Fluoride (0 ppm); Drug: Sodium fluoride (1150 ppm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195583

202194

RH02437 (Other Identifier)

Details and patient eligibility

About

This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
• Participants with maxillary dental arch suitable for the retention of the palatal appliance

Exclusion criteria

• Participants taking fluoride supplement
• Pregnant or breast-feeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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62 participants in 6 patient groups, including a placebo group

Sodium fluoride (1426 ppm)

Experimental group

Description:

Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base

Treatment:

Drug: Sodium fluoride (1426 ppm)

Sodium fluoride (1150 ppm)

Experimental group

Description:

Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base

Treatment:

Drug: Sodium fluoride (1150 ppm)

Sodium fluoride (250 ppm)

Experimental group

Description:

Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base

Treatment:

Drug: Sodium fluoride (250 ppm)

Sodium fluoride (1426 ppm) + zinc base A

Experimental group

Description:

Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base

Treatment:

Drug: Sodium fluoride (1426 ppm) + zinc base A

Sodium fluoride (1426 ppm) + zinc base B

Experimental group

Description:

Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base

Treatment:

Drug: Sodium fluoride (1426 ppm) + zinc base B

Fluoride (0 ppm)

Placebo Comparator group

Description:

Non-zinc, 0ppm fluoride in a silica gel base

Treatment:

Drug: Fluoride (0 ppm)