Root CariesNCT06514885
Silver Diamine Fluoride Application on Root Caries Fillings
A study testing SDF solution application and Tonic water in people with Root Caries, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to learn the influence of prior silver diamine fluoride (SDF) application on root caries fillings. The main questions to answer 1. Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application; 2. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Root Caries
- What is being tested?
- SDF solution application and Tonic water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2023to 1 Oct 2026
- 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
- Older adults (aged 60 or above)
- At least one untreated decayed dental root
Who cannot join
- No self-care ability for basic daily activities
- Teeth with severe decay (cannot be filled)
- Teeth indicated for extraction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Chloe Jiang, PhD, +852-28590507, cmjiang@hku.hk
About this study
Official title: Influence of Silver Diamine Fluoride Application on the Restorative Treatment for Root Caries
The goal of this clinical trial is to learn the influence of prior silver diamine fluoride (SDF) application on root caries fillings.
The main questions to answer
- Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application;
- Compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries.
Participants will be allocated into two group
- prior SDF application before receiving root caries fillings
- directly receiving root caries fillings without any SDF application
Read the detailed description
The aim of the proposed study is to investigate the influence of prior SDF application on the restorative treatment of root caries.
The objectives of the study are to
- Compare the success rate of restorations placed in root caries lesions that have prior SDF application and that of restorations placed without prior SDF application;
- Compare patient-based subjective evaluations on the two different approaches mentioned-above in treating root caries lesions.
Hypotheses to be tested:
- Prior SDF application increases the success rate of restorations placed in root caries;
- Patient-based subjective evaluations of the treatment outcomes are better when SDF is applied to the root caries lesions prior to restoring the lesions.
- Conditions
- Root Caries
- Being tested
- SDF solution application, Tonic water
- Keywords
- silver diamine fluoride, older adults, restorative treatment, root caries
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDF solution applicationOther
silver diamine fluoride (SDF) solution is highly effective in stopping and arresting the progress of decay in dental roots of older adults. The American Dental Association (ADA) has published a guideline based on the up-to-date evidence to support the use of SDF for managing tooth decay. As a non-invasive procedure, application of SDF is simple, quick, painless and non-aerosol generated.
Tonic waterOther
Tonic water will be used as a placebo to mimic the SDF solution.
| Study group | Role | What they receive |
|---|---|---|
| SDF group | Experimental | Participants of SDF group will be applied with SDF before placement of root caries restoration Receives: Other: SDF solution application |
| Control group | Placebo comparator | Participants of control group will be applied with placebo (tonic water) before placement of root caries restoration Receives: Other: Tonic water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
Compare the success rate of restorations placed in root caries lesions that have prior SDF application or that of restorations placed without prior SDF application
Measured: 24 months follow-up
Secondary outcomes (1)
Patient-based subjective evaluation
Compare patient-based subjective evaluations on the two different approaches in treating root caries lesions.
The Chinese version of General Oral Health Assessment Index (GOHAI) will be adopted as a tool to assess the oral health-related quality of life (OHRQoL) of the participants. It contains 12 questions covering three domains: physical function, pain and discomfort, and psychosocial function. The total GOHAI score is generated by adding up the score of each response to the 12 questions, and the total score ranges from 12 to 60. A higher score indicates a better perceived OHRQoL.
Measured: 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Oct 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Root CariesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-arm randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514885
- Sponsor's protocol ID
- UW23-005
- Status last verified
- Dec 2024
- First submitted
- 16 Jul 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li R, Lo EC, Liu BY, Wong MC, Chu CH. Randomized clinical trial on arresting dental root caries through silver diammine fluoride applications in community-dwelling elders. J Dent. 2016 Aug;51:15-20. doi: 10.1016/j.jdent.2016.05.005. Epub 2016 May 18.
PubMed 27208876Zhang W, McGrath C, Lo EC, Li JY. Silver diamine fluoride and education to prevent and arrest root caries among community-dwelling elders. Caries Res. 2013;47(4):284-90. doi: 10.1159/000346620. Epub 2013 Feb 5.
PubMed 23392087Lo EC, Luo Y, Tan HP, Dyson JE, Corbet EF. ART and conventional root restorations in elders after 12 months. J Dent Res. 2006 Oct;85(10):929-32. doi: 10.1177/154405910608501011.
PubMed 16998134
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Silver Diamine Fluoride Application on the Restorative Treatment for Root Caries
- ClinicalTrials.gov ID
- NCT06514885
- Acronym / sponsor ID
- UW23-005
- Conditions
- Root Caries
- Keywords
- silver diamine fluoride, older adults, restorative treatment, root caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 23 Jul 2024 (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 clinical trial is to learn the influence of prior silver diamine fluoride (SDF) application on root caries fillings.
The main questions to answer
- Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application;
- Compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries.
Participants will be allocated into two group
- prior SDF application before receiving root caries fillings
- directly receiving root caries fillings without any SDF application
Detailed description
The aim of the proposed study is to investigate the influence of prior SDF application on the restorative treatment of root caries.
The objectives of the study are to
- Compare the success rate of restorations placed in root caries lesions that have prior SDF application and that of restorations placed without prior SDF application;
- Compare patient-based subjective evaluations on the two different approaches mentioned-above in treating root caries lesions.
Hypotheses to be tested:
- Prior SDF application increases the success rate of restorations placed in root caries;
- Patient-based subjective evaluations of the treatment outcomes are better when SDF is applied to the root caries lesions prior to restoring the lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- two-arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| SDF group | Experimental | Other: SDF solution applicationParticipants of SDF group will be applied with SDF before placement of root caries restoration |
| Control group | Placebo comparator | Other: Tonic waterParticipants of control group will be applied with placebo (tonic water) before placement of root caries restoration |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older adults (aged 60 or above)
- At least one untreated decayed dental root
Key exclusion criteria (3 listed)
- No self-care ability for basic daily activities
- Teeth with severe decay (cannot be filled)
- Teeth indicated for extraction
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 |
|---|---|---|
| SDF solution applicationsilver diamine fluoride (SDF) solution is highly effective in stopping and arresting the progress of decay in dental roots of older adults. The American Dental Association (ADA) has published a guideline based on the up-to-date evidence to support the use of SDF for managing tooth decay. As a non-invasive procedure, application of SDF is simple, quick, painless and non-aerosol generated. | Other | SDF group |
| Tonic waterTonic water will be used as a placebo to mimic the SDF solution. | Other | Control group |
Primary outcome
Clinical outcome
Time frame: 24 months follow-up
Compare the success rate of restorations placed in root caries lesions that have prior SDF application or that of restorations placed without prior SDF application
1 secondary outcome
Patient-based subjective evaluation
Time frame: 24 months follow-up
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 9 Dec 2024.
- Background: PubMed 27208876Li R, Lo EC, Liu BY, Wong MC, Chu CH. Randomized clinical trial on arresting dental root caries through silver diammine fluoride applications in community-dwelling elders. J Dent. 2016 Aug;51:15-20. doi: 10.1016/j.jdent.2016.05.005. Epub 2016 May 18.
- Background: PubMed 23392087Zhang W, McGrath C, Lo EC, Li JY. Silver diamine fluoride and education to prevent and arrest root caries among community-dwelling elders. Caries Res. 2013;47(4):284-90. doi: 10.1159/000346620. Epub 2013 Feb 5.
- Background: PubMed 16998134Lo EC, Luo Y, Tan HP, Dyson JE, Corbet EF. ART and conventional root restorations in elders after 12 months. J Dent Res. 2006 Oct;85(10):929-32. doi: 10.1177/154405910608501011.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDF solution application and Tonic water in people with 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 24 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514885, which also lists 3 linked publications.
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 9 Dec 2024.