Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

NCT03185104 | Unknown DMC

• 1 other identifier: SDF RPD wearers
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries; Dental Caries of Root Surface

Keywords

removable partial denture; silver diamine fluoride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Prevalence of oral colonization of oral yeasts

  36 months

• Colonization of oral yeasts in oral rinse

  36 months

• Colonization of oral yeasts in dental plaque

  36 months

• Prevalence of oral colonization of Streptococcus mutans (S. mutans)

  36 months

• Colonization of S. mutans in saliva

  36 months

Study Arms (2)

Silver diamine fluoride

EXPERIMENTAL

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

Distilled water

PLACEBO COMPARATOR

Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.

Drug: Distilled Water

Interventions

Silver Diamine Fluoride DRUG

Silver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.

Also known as: Saforide

Silver diamine fluoride

Distilled Water DRUG

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

Distilled water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are wearing removable partial dentures constructed by staff or students at the Prince Philip Dental Hospital are recruited

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Dental Caries; Root Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Katherine CM Leung, BDS,MDS, PhD

  Faculty of Dentistry, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Application of the SDF/placebo is conducted by a dentist who is not involved in the clinical data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: June 14, 2017
• Study Start: November 1, 2013
• Primary Completion: June 30, 2017
• Study Completion: December 31, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06