Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries; Dental Caries of Root Surface
• Intervention / Treatment: Drug: Silver Diamine Fluoride; Drug: Distilled Water

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Saforide
Placebo Comparator: Distilled water; Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries increment	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.	36 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Katherine CM Leung, BDS,MDS, PhD, Faculty of Dentistry, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Anticipated): June 30, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: silver diamine fluoride; removable partial denture
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Root Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: SDF RPD wearers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No