Clinical trial NCT03185104: Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
Official title: Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Dental Caries of Root Surface
Keywords: removable partial denture
silver diamine fluoride
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Caries increment
timeFrame: 36 months
Secondary outcomes:
measure: Prevalence of oral colonization of oral yeasts
timeFrame: 36 months
measure: Colonization of oral yeasts in oral rinse
timeFrame: 36 months
measure: Colonization of oral yeasts in dental plaque
timeFrame: 36 months
measure: Prevalence of oral colonization of Streptococcus mutans (S. mutans)
timeFrame: 36 months
measure: Colonization of S. mutans in saliva
timeFrame: 36 months
measure: Colonization of S. mutans in dental plaque
timeFrame: 36 months
measure: Prevalence of oral colonization of lactobacilli
timeFrame: 36 months
measure: Colonization of lactobacilli in saliva
timeFrame: 36 months
measure: Colonization of lactobacilli in dental plaque
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Dentistry, The University of Hong Kong
name: Katherine CM Leung, BDS,MDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: