Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

The University of Hong Kong (HKU)

Status: Active, not recruiting

Conditions: Dental Caries of Root Surface; Root Caries

Treatments: Drug: Fluoride varnish; Combination Product: Fluoride varnish with SBGC

Study type: Interventional

Funder types: Other

Identifiers

NCT06131957

UW23-451

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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540 participants in 2 patient groups

Fluoride varnish with SBGC

Experimental group

Description:

This group will receive applications of fluoride varnish (containing 5% NaF) with 7.5% SBGC every 3 months for 36 months.

Treatment:

Combination Product: Fluoride varnish with SBGC

Fluoride varnish without SBGC

Active Comparator group

Description:

This group will receive 5% NaF varnish with SBGC every 3 months for 36 months.

Treatment:

Drug: Fluoride varnish