Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries of Root Surface, Root Caries

Intervention / Treatment
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* Combination Product: Fluoride varnish with SBGC
* Drug: Fluoride varnish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized assigned to either experimental group or controlled group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoride varnish with SBGC<br>This group will receive applications of fluoride varnish (containing 5% NaF) with 7.5% SBGC every 3 months for 36 months. | Combination Product: Fluoride varnish with SBGC<br>* The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) mixed with 7.5% SBGC (Dencare (Chongqing) Oral Care Co., Ltd).<br>|
| Active Comparator: Fluoride varnish without SBGC<br>This group will receive 5% NaF varnish with SBGC every 3 months for 36 months. | Drug: Fluoride varnish<br>* The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)<br>* Other names: Duraphat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New root caries lesions and restorations | 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. | Baseline, 12, 24, 36 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Root caries, Dentine, Prevention, Strontium-doped Bioactive Glass Ceramic, Fluoride varnish, Older adults