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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Oral Hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sodium fluoride (1426 ppm)

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

Group Type EXPERIMENTAL

Sodium fluoride (1426 ppm)

Intervention Type DRUG

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

Sodium fluoride (1150 ppm)

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

Group Type EXPERIMENTAL

Sodium fluoride (1150 ppm)

Intervention Type DRUG

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

Sodium fluoride (250 ppm)

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

Group Type EXPERIMENTAL

Sodium fluoride (250 ppm)

Intervention Type DRUG

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

Sodium fluoride (1426 ppm) + zinc base A

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

Group Type EXPERIMENTAL

Sodium fluoride (1426 ppm) + zinc base A

Intervention Type DRUG

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

Sodium fluoride (1426 ppm) + zinc base B

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

Group Type EXPERIMENTAL

Sodium fluoride (1426 ppm) + zinc base B

Intervention Type DRUG

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

Fluoride (0 ppm)

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

Group Type PLACEBO_COMPARATOR

Fluoride (0 ppm)

Intervention Type DRUG

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

Interventions

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Sodium fluoride (1426 ppm)

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

Intervention Type DRUG

Sodium fluoride (1150 ppm)

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

Intervention Type DRUG

Sodium fluoride (250 ppm)

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

Intervention Type DRUG

Sodium fluoride (1426 ppm) + zinc base A

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

Intervention Type DRUG

Sodium fluoride (1426 ppm) + zinc base B

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

Intervention Type DRUG

Fluoride (0 ppm)

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

Intervention Type DRUG

Eligibility Criteria

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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