Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-01

Study Completion Date

2017-12-31

Brief Summary

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This study measures and compares the effect of silver diamine fluoride (SDF) on caries increment in removable partial denture wearers. Half of the participants will SDF and while the other half will receive placebo.

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Detailed Description

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Removable partial dentures are commonly constructed to replace missing teeth. It is observed that removable partial denture wearers are susceptible to dental caries.

The mode of action of silver diamine fluoride on caries prevention is dual: fluoride ions interact synergistically with silver to react with hydroxyapatite to form fluorapatite, and silver is bactericidal by reacting with the thiol groups of the amino and nucleic acids that halt the metabolic and reproductive functions of the cariogenic bacteria.

Conditions

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Dental Caries Dental Caries of Root Surface

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Removable partial denture wearers are randomized assigned to either the fluoride group or the placebo group. The fluoride group receives semi-annually professionally applied 38% SDF solution to all exposed tooth and root surfaces while the placebo group receives distilled water using the same application method.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Application of the SDF/placebo is conducted by a dentist who is not involved in the clinical data collection.

Study Groups

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Silver diamine fluoride

38% silver diamine fluoride solution (Saforide, Toyo Seiyaku Kasei Co. Ltd., Osaka, Japan) is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.

Group Type EXPERIMENTAL

Silver Diamine Fluoride

Intervention Type DRUG

Silver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.

Distilled water

Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.

Group Type PLACEBO_COMPARATOR

Distilled Water

Intervention Type DRUG

Distilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.

Interventions

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Silver Diamine Fluoride

Silver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.

Intervention Type DRUG

Distilled Water

Distilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.

Intervention Type DRUG

Other Intervention Names

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Saforide

Eligibility Criteria

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Inclusion Criteria

* Patients who are wearing removable partial dentures constructed by staff or students at the Prince Philip Dental Hospital are recruited

Exclusion Criteria

* If they have less than 4 teeth in any dental arch, have advanced periodontal disease in 2 or more sextants, have received therapeutic radiation of the head and neck region, have concurrent systemic illness that alters salivary flow, or have participated in a clinical trial within 6 months before the commencement of participation in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No