Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

Root Caries Clinical Trial

— SBGC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06131957
• Other study ID #: UW23-451
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 2027

Study information

• Verified date: September 2023
• Source: The University of Hong Kong
• Contact: Katherine CM Leung, BDS,MDS,PhD
• Phone: (+852) 28590307
• Email: kcmleung[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: December 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries of Root Surface
• Root Caries

Intervention

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).

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

Locations

Country	Name	City	State
Hong Kong	Clinical Research Center, the Prince Philips Dental Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Arrested root caries	An active root caries lesion found at baseline changed into inactive at follow-ups, according to ICDAS II criteria.	Baseline, 12, 24, 36 months
Secondary	Satisfaction of the use of varnish	Investigated by survey.	12, 24, 36 months