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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03185104
Enrollment
196
Registered
2017-06-14
Start date
2013-11-01
Completion date
2017-12-31
Last updated
2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Dental Caries of Root Surface

Keywords

removable partial denture, silver diamine fluoride

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.

Interventions

DRUGSilver 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.

DRUGDistilled Water

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

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Caries increment36 monthsNew 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

MeasureTime frameDescription
Colonization of oral yeasts in oral rinse36 monthsThe 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.
Colonization of oral yeasts in dental plaque36 monthsThe 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 monthsThe prevalence S. mutans in stimulated whole saliva (SWS) and dental plaque is counted. Prevalence is expressed as percentage of the participants.
Colonization of S. mutans in saliva36 monthsThe count of S. mutans in SWS is recorded. The count of S. mutans in SWS is expressed as cfu/ml.
Prevalence of oral colonization of oral yeasts36 monthsThe prevalence of oral yeast in oral rinse and dental plaque is counted. Prevalence is expressed as percentage of the participants.
Prevalence of oral colonization of lactobacilli36 monthsThe prevalence of lactobacilli in SWS and dental plaque is counted. Prevalence is expressed as percentage of the participants.
Colonization of lactobacilli in saliva36 monthsThe count of lactobacilli in SWS is recorded. The count of lactobacilli in SWS is expressed as cfu/ml.
Colonization of lactobacilli in dental plaque36 monthsThe count of lactobacilli in dental plaque is recorded. The count of lactobacilli in dental plaque is expressed as cfu/g.
Colonization of S. mutans in dental plaque36 monthsThe count of S. mutans dental plaque is recorded. The count of S. mutans in dental plaque is expressed as cfu/g.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026