Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

N/AActive Not RecruitingNCT06131957

The University of Hong Kong540 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

540

Conditions

Dental Caries of Root Surface Root Caries

Interventions

Fluoride varnish with SBGCCOMBINATION_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 varnishDRUG

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Research Center, the Prince Philips Dental Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 12, 24, 36 months

Secondary Outcomes

Arrested root caries

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

Time frame: Baseline, 12, 24, 36 months

Satisfaction of the use of varnish

Investigated by survey.

Time frame: 12, 24, 36 months

Data from ClinicalTrials.gov

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