Active, not recruitingNCT06131957SBGCUpdated Apr 29, 2026

Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

An interventional study of Fluoride varnish with SBGC and Fluoride varnish in Dental Caries of Root Surface and Root Caries, sponsored by The University of Hong Kong. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 540
Allocation: Randomized
Ages: 60 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Dental Caries of Root Surface
Root Caries

Browse trials for

Root Caries 39

Keywords

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

In context

Root Caries

39 studies on the registry are indexed under Root Caries; 14 are open to participants now.

This study's planned enrollment of 540 is above the median of 62 across 35 interventional studies indexed under Root Caries.

Browse Root Caries studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 60 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adult > 60 years old
good collaborative relationships

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 540 participants (estimated)

Study arms

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
Active comparator
Fluoride varnish without SBGC
This group will receive 5% NaF varnish with SBGC every 3 months for 36 months.
Drug: Fluoride varnish

Interventions

Combination productFluoride 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).
DrugFluoride varnish
The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)
Also known as: Duraphat

What researchers measure

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

Study locations

1 site

Clinical Research Center, the Prince Philips Dental Hospital
Hong Kong, Hong Kong

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Jan 2027, 36 months after the start.

Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 8, 2023
First posted: Nov 15, 2023
StartActual: Jan 15, 2024
Primary completionEst.: Jan 2027
CompletionEst.: Dec 2027
Last update: Apr 29, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06131957
Lead sponsor: The University of Hong Kong
Responsible party: Sponsor
First posted: Nov 15, 2023
Start date: Jan 15, 2024
Primary completion: Jan 2027 (estimated)
Completion: Dec 2027 (estimated)
Last update: Apr 29, 2026

Study contacts

Katherine CM Leung, BDS,MDS,PhD

principal investigator · Faculty of Dentistry, The University of Hong Kong

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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