Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

Not Applicable

Recruiting

• Conditions: Dental Caries of Root Surface; Root Caries
• Interventions: Combination Product: Fluoride varnish with SBGC; Drug: Fluoride varnish

• Registration Number: NCT06131957
• Lead Sponsor: The University of Hong Kong

Brief Summary

The goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.

Detailed Description

This 36-month, double-blind, two-arm randomized controlled trial is aimed to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.

Participants will be divided in to two groups, The main question it aims to answer is: Is fluoride varnish with SBGC more effective than that without SBGC on prevention root caries in community-dwelling older adults? Participants will be divided into two groups, experimental group and controlled group after randomization. Subjects in the experimental group will receive fluoride varnish with SBGC quarterly, and subjects in the controlled group will receive fluoride varnish without SBGC quarterly.

It is hypothesized that community-dwelling older adults who receive quarterly fluoride varnish applications containing SBGC will develop fewer root caries.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-12
• Study First Posted: 2023-11-15
• Study Start: 2024-01-15
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2027-01
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Adult > 60 years old
• good collaborative relationships

Exclusion Criteria

• less than 8 natural teeth
• have severe medical conditions
• are in use of high fluoride toothpaste

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride varnish with SBGC	Fluoride varnish with SBGC	This group will receive applications of fluoride varnish (containing 5% NaF) with 7.5% SBGC every 3 months for 36 months.
Fluoride varnish without SBGC	Fluoride varnish	This group will receive 5% NaF varnish with SBGC every 3 months for 36 months.

Primary Outcome Measures

Name	Time	Method
New root caries lesions and restorations	Baseline, 12, 24, 36 months	All exposed root surfaces will be examined for new caries lesions based on the ICDAS criteria. Restorations due to root caries will also be recorded after confirmation with the subjects.

Secondary Outcome Measures

Name	Time	Method
Arrested root caries	Baseline, 12, 24, 36 months	An active root caries lesion found at baseline changed into inactive at follow-ups, according to ICDAS II criteria.
Satisfaction of the use of varnish	12, 24, 36 months	Investigated by survey.

Trial Locations

Locations (1)

Clinical Research Center, the Prince Philips Dental Hospital; 🇭🇰 Hong Kong, Hong Kong