Dental Caries of Root SurfaceSBGCNCT06131957
Root Caries Prevention Using Fluoride Varnish Fortified With SBGC
A study testing Fluoride varnish with SBGC and Fluoride varnish in people with Dental Caries of Root Surface and Root Caries, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dental Caries of Root Surface, Root Caries
- What is being tested?
- Fluoride varnish with SBGC and Fluoride varnish
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jan 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult > 60 years old
- good collaborative relationships
Who cannot join
- less than 8 natural teeth
- have severe medical conditions
- are in use of high fluoride toothpaste
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Clinical Research Center, the Prince Philips Dental Hospital
Hong Kong
About this study
Official title: Root Caries Prevention Using Fluoride Varnish Fortified With Strontium-doped Bioactive Glass Ceramic: a Randomized Double-blind Controlled Clinical Trial
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
- Dental Caries of Root Surface, Root Caries
- Being tested
- Fluoride varnish with SBGC, Fluoride varnish
- Keywords
- Strontium-doped Bioactive Glass Ceramic, Fluoride varnish, Older adults, Root caries, Dentine, Prevention
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called Duraphat
The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12, 24, 36 months
Secondary outcomes (2)
Arrested root caries
An active root caries lesion found at baseline changed into inactive at follow-ups, according to ICDAS II criteria.
Measured: Baseline, 12, 24, 36 months
Satisfaction of the use of varnish
Investigated by survey.
Measured: 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start15 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries of Root SurfaceStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized assigned to either experimental group or controlled group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine CM Leung, BDS,MDS,PhD, Principal investigator, Faculty of Dentistry, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131957
- Sponsor's protocol ID
- UW23-451
- Acronym
- SBGC
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Caries Prevention Using Fluoride Varnish Fortified With Strontium-doped Bioactive Glass Ceramic: a Randomized Double-blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06131957
- Acronym / sponsor ID
- SBGC / UW23-451
- Conditions
- Dental Caries of Root Surface, Root Caries
- Keywords
- Strontium-doped Bioactive Glass Ceramic, Fluoride varnish, Older adults, Root caries, Dentine, Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized assigned to either experimental group or controlled group.
| Arm | Type | Receives |
|---|---|---|
| Fluoride varnish with SBGC | Experimental | Combination Product: Fluoride varnish with SBGCThis group will receive applications of fluoride varnish (containing 5% NaF) with 7.5% SBGC every 3 months for 36 months. |
| Fluoride varnish without SBGC | Active comparator | Drug: Fluoride varnishThis group will receive 5% NaF varnish with SBGC every 3 months for 36 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult > 60 years old
- good collaborative relationships
Key exclusion criteria (3 listed)
- less than 8 natural teeth
- have severe medical conditions
- are in use of high fluoride toothpaste
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride varnish with SBGCThe Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) mixed with 7.5% SBGC (Dencare (Chongqing) Oral Care Co., Ltd). | Combination product | Fluoride varnish with SBGC |
| Fluoride varnishAlso: DuraphatThe Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) | Drug | Fluoride varnish without SBGC |
Primary outcome
New root caries lesions and restorations
Time frame: Baseline, 12, 24, 36 months
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.
2 secondary outcomes
Arrested root caries
Time frame: Baseline, 12, 24, 36 months
Satisfaction of the use of varnish
Time frame: 12, 24, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine CM Leung, BDS,MDS,PhD principal investigator
Faculty of Dentistry, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride varnish with SBGC and Fluoride varnish in people with Dental Caries of Root Surface and Root Caries, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New root caries lesions and restorations (time frame: Baseline, 12, 24, 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.