Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- The University of Hong Kong
- Enrollment
- 196
- Primary Endpoint
- Caries increment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Application of the SDF/placebo is conducted by a dentist who is not involved in the clinical data collection.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Silver Diamine Fluoride (Drug)
Distilled water
Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.
Intervention: Distilled Water (Drug)
Outcomes
Primary Outcomes
Caries increment
Time Frame: 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 Outcomes
- Colonization of S. mutans in saliva(36 months)
- Colonization of S. mutans in dental plaque(36 months)
- Colonization of oral yeasts in oral rinse(36 months)
- Prevalence of oral colonization of oral yeasts(36 months)
- Colonization of oral yeasts in dental plaque(36 months)
- Prevalence of oral colonization of Streptococcus mutans (S. mutans)(36 months)
- Colonization of lactobacilli in dental plaque(36 months)
- Prevalence of oral colonization of lactobacilli(36 months)
- Colonization of lactobacilli in saliva(36 months)