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Active, Not Recruiting

NCT Number: NCT06131957

Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dental Caries of Root Surface Dental Caries Root Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center, the Prince Philips Dental Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride varnish with SBGC

Combination Product

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

Fluoride varnish

Drug

The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)

Other names: Duraphat

Primary outcomes

  1. New root caries lesions and restorations

    Time frame: 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 outcomes

  1. Arrested root caries

    Time frame: Baseline, 12, 24, 36 months

    An active root caries lesion found at baseline changed into inactive at follow-ups, according to ICDAS II criteria.

  2. Satisfaction of the use of varnish

    Time frame: 12, 24, 36 months

    Investigated by survey.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Acronym: SBGC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 15, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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