Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03185104
• Other study ID #: SDF RPD wearers
• Status: Active, not recruiting
• Phase: N/A
• First received: April 24, 2017
• Last updated: June 9, 2017
• Start date: November 1, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: December 31, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries of Root Surface
• Root Caries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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