Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

NCT06131957 | Active Not Recruiting

• 1 other identifier: UW23-451
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries of Root Surface; Root Caries

Keywords

Strontium-doped Bioactive Glass Ceramic; Fluoride varnish; Older adults; Root caries; Dentine; Prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12, 24, 36 months

Secondary Outcomes (2)

• Arrested root caries

  Baseline, 12, 24, 36 months

• Satisfaction of the use of varnish

  12, 24, 36 months

Study Arms (2)

Fluoride varnish with SBGC

EXPERIMENTAL

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

Fluoride varnish without SBGC

ACTIVE COMPARATOR

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

Drug: Fluoride varnish

Interventions

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 with SBGC

Fluoride varnish DRUG

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

Also known as: Duraphat

Fluoride varnish without SBGC

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult \> 60 years old
• good collaborative relationships

You may not qualify if:

• less than 8 natural teeth
• have severe medical conditions
• are in use of high fluoride toothpaste

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Clinical Research Center, the Prince Philips Dental Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Root Caries

Interventions

sodium fluoride topical preparation

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Katherine CM Leung, BDS,MDS,PhD

  Faculty of Dentistry, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized assigned to either experimental group or controlled group.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 15, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)