Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

Not Applicable

• Conditions: Dental Caries; Dental Caries of Root Surface
• Interventions: Drug: Silver Diamine Fluoride; Drug: Distilled Water

• Registration Number: NCT03185104
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-11-01
• Study First Submitted: 2017-04-24
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-09
• Last Update Submitted: 2017-06-09
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Primary Completion: 2017-06-30
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver diamine fluoride	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.
Distilled water	Distilled Water	Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.

Primary Outcome Measures

Name	Time	Method
Caries increment	36 months	New and recurrent caries lesions are recorded according to the International Caries Detection and Assessment System (ICDAS). Molars and premolars are considered to have 5 coronal surfaces, whereas canines and incisors are considered to have 4. The cleaned and dried teeth are recorded as sound, sealed, restored, crowned, or missing. Each coronal tooth surface is classified using a 7-point ordinal scale ranging from sound to extensive cavitation using a WHO probe. The same procedure is repeated for all root surfaces. Coronal and root surface caries increments are calculated by comparing the baseline and follow-up observations for each tooth surface.

Secondary Outcome Measures

Name	Time	Method
Colonization of S. mutans in saliva	36 months	The count of S. mutans in SWS is recorded. The count of S. mutans in SWS is expressed as cfu/ml.
Colonization of S. mutans in dental plaque	36 months	The count of S. mutans dental plaque is recorded. The count of S. mutans in dental plaque is expressed as cfu/g.
Colonization of oral yeasts in oral rinse	36 months	The count of oral yeasts in oral rinse is recorded. The count of oral yeast in oral rinse is expressed as colony-forming unit (cfu)/ml.
Prevalence of oral colonization of oral yeasts	36 months	The prevalence of oral yeast in oral rinse and dental plaque is counted. Prevalence is expressed as percentage of the participants.
Colonization of oral yeasts in dental plaque	36 months	The count of oral yeasts in dental plaque is recorded. The count of oral yeast in dental plaque is expressed as cfu/g.
Prevalence of oral colonization of Streptococcus mutans (S. mutans)	36 months	The prevalence S. mutans in stimulated whole saliva (SWS) and dental plaque is counted. Prevalence is expressed as percentage of the participants.
Colonization of lactobacilli in dental plaque	36 months	The count of lactobacilli in dental plaque is recorded. The count of lactobacilli in dental plaque is expressed as cfu/g.
Prevalence of oral colonization of lactobacilli	36 months	The prevalence of lactobacilli in SWS and dental plaque is counted. Prevalence is expressed as percentage of the participants.
Colonization of lactobacilli in saliva	36 months	The count of lactobacilli in SWS is recorded. The count of lactobacilli in SWS is expressed as cfu/ml.