Root Caries Prevention Using Fluoride Varnish Fortified With SBGC (SBGC)

February 19, 2024 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Katherine CM Leung, BDS,MDS,PhD
  • Phone Number: (+852) 28590307
  • Email: kcmleung@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Clinical Research Center, the Prince Philips Dental Hospital
        • Contact:
          • Catherine Mok
          • Phone Number: 28590222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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).
Active Comparator: Fluoride varnish without SBGC
This group will receive 5% NaF varnish with SBGC every 3 months for 36 months.
Drug: Fluoride varnish
The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)
Other Names:
  • Duraphat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12, 24, 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12, 24, 36 months
Satisfaction of the use of varnish
Time Frame: 12, 24, 36 months
Investigated by survey.
12, 24, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Katherine CM Leung, BDS,MDS,PhD, Faculty of Dentistry, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW23-451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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