Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06131957

Collaborator

(none)

540

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries of Root Surface Root Caries	Combination Product: Fluoride varnish with SBGC Drug: Fluoride varnish	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are randomized assigned to either experimental group or controlled group.Participants are randomized assigned to either experimental group or controlled group.

Masking:

Double (Participant, Investigator)

Masking Description:

The subjects and the clinical team including the dentist and the dental surgery assistant will all be blinded to the subjects' assignment of the intervention.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.