Dental Caries in ChildrenNCT03480516
Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children
A study testing SDF and Fluoride varnish in people with Dental Caries in Children and Satisfaction, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Tooth decay is one of the most common chronic infectious disease found in children worldwide and if left untreated, is rapidly progress. Severe tooth decay in children is not only affect child's health and school performance, but also has impact on the family well-being. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Satisfaction, Cost Effectiveness
- What is being tested?
- SDF and Fluoride varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2017to 31 Jul 2019
- 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- School children aged 6- 7 years old.
- Have at least one or more active dentin caries lesions in primary canine/molar.
- Parents give consent.
Who cannot join
- Uncooperative child
- Allergic reaction to silver or materials containing adhesive.
- Received topical fluoride 3 months prior to enrollment.
- Primary carers are unable to response to questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Silver Diamine Fluoride (SDF) and Fluoride Varnish in Arresting and Preventing Dental Caries in Primary School Children: Randomized Controlled Clinical Trial
Tooth decay is one of the most common chronic infectious disease found in children worldwide and if left untreated, is rapidly progress. Severe tooth decay in children is not only affect child's health and school performance, but also has impact on the family well-being. Oral rehabilitation in children requires time, resources and effort of dental specialists, the child and parents. Caries is a destructive condition of organic and inorganic components of the tooth structures but reversible and most importantly, preventable. Topical fluoride therapy, delivered by dentists has been effectively used to speed up the repair process as well as to strengthen the surface of intact tooth structure. Topical fluoride is available in various preparations. Regular application of sodium fluoride varnish is every three months, by far, considered as effective method in preventing new caries, particularly in the high-risk children. It has the advantage of containing therapeutic concentration of fluoride and ability to flow over and stick to the tooth surface. Whereas silver ion and relatively higher fluoride concentration in Silver Diamine Fluoride (SDF) has been shown to be the most effective in harden the decay, stop the caries progress and eliminate pathogenic bacteria. It can be hypothesize that when use in combination in school children, both reagents might have synergistic effect on arresting existing caries as well as preventing new caries.
Read the detailed description
Fluoride varnish is a good choice to consider. For caries prevention in young children, It has high efficacy in caries prevention.
Fluoride varnish has a high F concentration and prolong contact time with enamel, So it can prevent new caries and remineralize initial enamel caries. Silver diamine fluoride solution is effective in arresting dentine caries. Silver diamine fluoride has high fluoride concentration and contain silver ion. when apply dentine caries or cavitated caries can increase hardness of dentine and arresting caries.
When use in combination, it might enhance, the Efficacy in Arresting and Preventing Dental Caries in children
- Being tested
- SDF, Fluoride varnish
- Keywords
- Silver Diamine Fluoride, Sodium Fluoride Varnish, Arrest caries, Caries prevention, Cost Effectiveness, Oral Health, Quality of Life
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFDevice
Also called Silver diamine fluoride
38% silver diamine fluoride solution
Fluoride varnishDevice
Also called Sodium fluoride varnish
5% sodium fluoride varnish
| Study group | Role | What they receive |
|---|---|---|
| SDF arm | Experimental | SDF arm is application of 38% silver diamine fluoride solution (SDF) on cavitated caries in primary molar, , cavities in anterior teeth will be applied only on additional consent obtained. Receives: Device: SDF |
| Fluoride varnish arm | Experimental | Fluoride varnish arm is application of 5% sodium fluoride varnish on all surface of every tooth. Receives: Device: Fluoride varnish |
| Combination arm | Experimental | Combination arm is application of 38% silver diamine fluoride solution(SDF) on cavitated caries in primary molar, , cavities in anterior teeth will be applied only on additional consent obtained and then apply of 5% sodium fluoride varnish on all surface of every tooth. Receives: Device: SDF; Device: Fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of arrested caries lesion changed from baseline
Number of arrested caries lesion changed from baseline. The arresting dentine caries lesion was evaluated at 18 months after first application. Evaluation criteria included the condition of the hardness and discoloration of carious lesion. The carious lesion was re-categorized as a binary outcome: Dental caries (active/inactive)
Measured: 18 months
Secondary outcomes (10)
Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 6 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Measured: 6 months
Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 12 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Measured: 12 months
Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 18 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Measured: 18 months
Parental satisfaction
parental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks.
Measured: 2 weeks
Parental satisfaction
parental satisfaction will be collected, by a seft-administered questionnaire, at 18 months
Measured: 18 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 6 months
Measured: 6 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 12 months
Measured: 12 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 18 months
Measured: 18 months
Cost Effectiveness
Cost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months
Measured: 18 months
Oral Health-Related Quality of life
Oral health related quality of life in children is being measured using the Child-Oral Impacts on Daily Performance Index (Child-OIDP) at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Sep 2017
- Primary completion30 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemporn Kitsahawong, Khon Kaen University
- Investigators
- Kemporn Kitsahawong, DDS., MSc., Principal investigator, Faculty of Dentistry, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480516
- Sponsor's protocol ID
- KKUHE602106
- Status last verified
- Sep 2018
- First submitted
- 11 Mar 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- 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 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Silver Diamine Fluoride (SDF) and Fluoride Varnish in Arresting and Preventing Dental Caries in Primary School Children: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03480516
- Acronym / sponsor ID
- KKUHE602106
- Keywords
- Silver Diamine Fluoride, Sodium Fluoride Varnish, Arrest caries, Caries prevention, Cost Effectiveness, Oral Health, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 29 Mar 2018 (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.
Tooth decay is one of the most common chronic infectious disease found in children worldwide and if left untreated, is rapidly progress. Severe tooth decay in children is not only affect child's health and school performance, but also has impact on the family well-being. Oral rehabilitation in children requires time, resources and effort of dental specialists, the child and parents. Caries is a destructive condition of organic and inorganic components of the tooth structures but reversible and most importantly, preventable. Topical fluoride therapy, delivered by dentists has been effectively used to speed up the repair process as well as to strengthen the surface of intact tooth structure. Topical fluoride is available in various preparations. Regular application of sodium fluoride varnish is every three months, by far, considered as effective method in preventing new caries, particularly in the high-risk children. It has the advantage of containing therapeutic concentration of fluoride and ability to flow over and stick to the tooth surface. Whereas silver ion and relatively higher fluoride concentration in Silver Diamine Fluoride (SDF) has been shown to be the most effective in harden the decay, stop the caries progress and eliminate pathogenic bacteria. It can be hypothesize that when use in combination in school children, both reagents might have synergistic effect on arresting existing caries as well as preventing new caries.
Detailed description
Fluoride varnish is a good choice to consider. For caries prevention in young children, It has high efficacy in caries prevention.
Fluoride varnish has a high F concentration and prolong contact time with enamel, So it can prevent new caries and remineralize initial enamel caries. Silver diamine fluoride solution is effective in arresting dentine caries. Silver diamine fluoride has high fluoride concentration and contain silver ion. when apply dentine caries or cavitated caries can increase hardness of dentine and arresting caries.
When use in combination, it might enhance, the Efficacy in Arresting and Preventing Dental Caries in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SDF arm | Experimental | Device: SDFSDF arm is application of 38% silver diamine fluoride solution (SDF) on cavitated caries in primary molar, , cavities in anterior teeth will be applied only on additional consent obtained. |
| Fluoride varnish arm | Experimental | Device: Fluoride varnishFluoride varnish arm is application of 5% sodium fluoride varnish on all surface of every tooth. |
| Combination arm | Experimental | Device: SDF, Device: Fluoride varnishCombination arm is application of 38% silver diamine fluoride solution(SDF) on cavitated caries in primary molar, , cavities in anterior teeth will be applied only on additional consent obtained and then apply of 5% sodium fluoride varnish on all surface of every tooth. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- School children aged 6- 7 years old.
- Have at least one or more active dentin caries lesions in primary canine/molar.
- Parents give consent.
Key exclusion criteria (4 listed)
- Uncooperative child
- Allergic reaction to silver or materials containing adhesive.
- Received topical fluoride 3 months prior to enrollment.
- Primary carers are unable to response to questionnaire.
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 |
|---|---|---|
| SDFAlso: Silver diamine fluoride38% silver diamine fluoride solution | Device | Combination arm, SDF arm |
| Fluoride varnishAlso: Sodium fluoride varnish5% sodium fluoride varnish | Device | Combination arm, Fluoride varnish arm |
Primary outcome
Number of arrested caries lesion changed from baseline
Time frame: 18 months
Number of arrested caries lesion changed from baseline. The arresting dentine caries lesion was evaluated at 18 months after first application. Evaluation criteria included the condition of the hardness and discoloration of carious lesion. The carious lesion was re-categorized as a binary outcome: Dental caries (active/inactive)
10 secondary outcomes
Increasing number of new caries lesion from baseline
Time frame: 6 months
Increasing number of new caries lesion from baseline
Time frame: 12 months
Increasing number of new caries lesion from baseline
Time frame: 18 months
Parental satisfaction
Time frame: 2 weeks
Parental satisfaction
Time frame: 18 months
Child satisfaction
Time frame: 6 months
Child satisfaction
Time frame: 12 months
Child satisfaction
Time frame: 18 months
Cost Effectiveness
Time frame: 18 months
Oral Health-Related Quality of life
Time frame: 12 months
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 6 Aug 2019.
- 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.
Kemporn Kitsahawong, DDS., MSc. principal investigator
Faculty of Dentistry, Khon Kaen University
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 and Fluoride varnish in people with Dental Caries in Children and Satisfaction, run by Khon Kaen University at 1 site in Thailand.
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 3 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 6 Aug 2019. 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 Thailand. 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?
Number of arrested caries lesion changed from baseline (time frame: 18 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 6 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.