NCT06131957

Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

Root Caries Prevention Using Fluoride Varnish Fortified With Strontium-doped Bioactive Glass Ceramic: a Randomized Double-blind Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Caries of Root Surface
• Root Caries

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Fluoride varnish with SBGC	The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) mixed with 7.5% SBGC (Dencare (Chongqing) Oral Care Co., Ltd).
DRUG	Fluoride varnish	The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)

Timeline

• Start date: 2024-01-15
• Primary completion: 2027-01-01
• Completion: 2027-12-01
• First posted: 2023-11-15
• Last updated: 2025-06-10

Locations

1 site across 1 country: Hong Kong