Dental CariesNCT05655286
Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries
A study testing 38% SDF treatment, not to rinse for at least 30 minutes after SDF treatment and rinse mouth immediately after SDF treatment in people with Dental Caries, run by The University of Hong Kong at 1 site in China.
Trial summary
To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- 38% SDF treatment, not to rinse for at least 30 minutes after SDF treatment and rinse mouth immediately after SDF treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-5 year old children attending the first to the third year of kindergarten;
- free from any systemic conditions and generally healthy;
- parents sign informed consent;
- having at least 1 tooth with cavitated dentine carious lesion
Who cannot join
- are uncooperative to accept oral examination or treatment;
- have a significant systematic disease or long-term medications;
- have abnormal dentition.
- Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children
To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children
Read the detailed description
Methods: The randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows.
Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.
Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups.
Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.
- Conditions
- Dental Caries
- Being tested
- 38% SDF treatment, not to rinse for at least 30 minutes after SDF treatment, rinse mouth immediately after SDF treatment
- Keywords
- dental caries, preschool children, silver diamine fluoride
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
38% SDF treatmentDrug
Children with active caries will receive 38% silver diamine fluoride treatment
not to rinse for at least 30 minutes after SDF treatmentBehavioural
After receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes.
rinse mouth immediately after SDF treatmentBehavioural
After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.
| Study group | Role | What they receive |
|---|---|---|
| Group A- immediately rinse mouth | Experimental | Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children. Receives: Drug: 38% SDF treatment; Behavioral: rinse mouth immediately after SDF treatment |
| Group B- not to rinse for at least 30 minutes | Experimental | Children are instructed not to eat and drink for at least 30 minutes. Receives: Drug: 38% SDF treatment; Behavioral: not to rinse for at least 30 minutes after SDF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries status
The proportion of the soft (active) carious tooth lesion surfaces that harden (arrested) at 12 months of follow-up will be measured
Measured: at 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Jan 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Hung Chu, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655286
- Sponsor's protocol ID
- HKU20221001
- Status last verified
- May 2024
- First submitted
- 30 Nov 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun IG, Duangthip D, Lo ECM, Chu CH. The Caries-Arrest Effectiveness of Silver Diamine Fluoride Treatment with Different Post-Treatment Instructions in Preschool Children: A Study Protocol for a Randomized Controlled Trial. Dent J (Basel). 2023 Jun 5;11(6):145. doi: 10.3390/dj11060145.
PubMed 37366668
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children
- ClinicalTrials.gov ID
- NCT05655286
- Acronym / sponsor ID
- HKU20221001
- Conditions
- Dental Caries
- Keywords
- dental caries, preschool children, silver diamine fluoride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 19 Dec 2022 (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.
To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children
Detailed description
Methods: The randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows.
Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.
Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups.
Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A- immediately rinse mouth | Experimental | Drug: 38% SDF treatment, Behavioral: rinse mouth immediately after SDF treatmentChildren are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children. |
| Group B- not to rinse for at least 30 minutes | Experimental | Drug: 38% SDF treatment, Behavioral: not to rinse for at least 30 minutes after SDF treatmentChildren are instructed not to eat and drink for at least 30 minutes. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3-5 year old children attending the first to the third year of kindergarten;
- free from any systemic conditions and generally healthy;
- parents sign informed consent;
- having at least 1 tooth with cavitated dentine carious lesion
Key exclusion criteria (4 listed)
- are uncooperative to accept oral examination or treatment;
- have a significant systematic disease or long-term medications;
- have abnormal dentition.
- Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.
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 |
|---|---|---|
| 38% SDF treatmentChildren with active caries will receive 38% silver diamine fluoride treatment | Drug | Group A- immediately rinse mouth, Group B- not to rinse for at least 30 minutes |
| not to rinse for at least 30 minutes after SDF treatmentAfter receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes. | Behavioural | Group B- not to rinse for at least 30 minutes |
| rinse mouth immediately after SDF treatmentAfter receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately. | Behavioural | Group A- immediately rinse mouth |
Primary outcome
Caries status
Time frame: at 12-month follow-up
The proportion of the soft (active) carious tooth lesion surfaces that harden (arrested) at 12 months of follow-up will be measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 37366668Sun IG, Duangthip D, Lo ECM, Chu CH. The Caries-Arrest Effectiveness of Silver Diamine Fluoride Treatment with Different Post-Treatment Instructions in Preschool Children: A Study Protocol for a Randomized Controlled Trial. Dent J (Basel). 2023 Jun 5;11(6):145. doi: 10.3390/dj11060145.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 38% SDF treatment, not to rinse for at least 30 minutes after SDF treatment and rinse mouth immediately after SDF treatment in people with Dental Caries, run by The University of Hong Kong at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 May 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Caries status (time frame: at 12-month 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 NCT05655286, which also lists 1 linked publication.
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 22 May 2024.