Dental CariesPhase 2NCT01829334
Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
A Phase 2 study testing ART dental sealant, Resin dental sealant and Sodium fluoride varnish in people with Dental Caries, run by The University of Hong Kong at 1 site in China.
Trial summary
The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- ART dental sealant, Resin dental sealant and Sodium fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 1 siteChina
- Study dates
- Jun 2006to May 2009
- Phase
- Phase 2
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- school children in good general health
- has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries
Who cannot join
- children with major systemic disease or on long-term medication
- children not cooperative and refuse dental treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.
The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.
Read more
The specific study objectives are:
- to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
- to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
- to compare the cost-effectiveness of the above four caries prevention methods.
- Conditions
- Dental Caries
- Being tested
- ART dental sealant, Resin dental sealant, Sodium fluoride varnish, Silver fluoride solution
- Keywords
- dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART dental sealantOther
ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
Resin dental sealantOther
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
Sodium fluoride varnishOther
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
Silver fluoride solutionOther
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
| Study group | Role | What they receive |
|---|---|---|
| Resin dental sealant | Active comparator | Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement Receives: Other: Resin dental sealant |
| ART dental sealant | Experimental | ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement Receives: Other: ART dental sealant |
| Sodium fluoride varnish | Experimental | Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months Receives: Other: Sodium fluoride varnish |
| Silver fluoride solution | Experimental | Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months Receives: Other: Silver fluoride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental caries
development of carious cavity after 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJun 2006
- Primary completionMay 2009
- Study completionMay 2009
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LO, Edward Chin Man, The University of Hong Kong
- Investigators
- Edward CM Lo, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829334
- Sponsor's protocol ID
- UW 06-203
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu BY, Xiao Y, Chu CH, Lo EC. Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial. BMC Oral Health. 2014 May 19;14:54. doi: 10.1186/1472-6831-14-54.
PubMed 24886444
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
- ClinicalTrials.gov ID
- NCT01829334
- Acronym / sponsor ID
- UW 06-203
- Conditions
- Dental Caries
- Keywords
- dental caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Apr 2013 (estimated)
- 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 aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.
The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.
The specific study objectives are:
- to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
- to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
- to compare the cost-effectiveness of the above four caries prevention methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resin dental sealant | Active comparator | Other: Resin dental sealantResin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement |
| ART dental sealant | Experimental | Other: ART dental sealantART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement |
| Sodium fluoride varnish | Experimental | Other: Sodium fluoride varnishTopical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months |
| Silver fluoride solution | Experimental | Other: Silver fluoride solutionTopical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- school children in good general health
- has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries
Key exclusion criteria (2 listed)
- children with major systemic disease or on long-term medication
- children not cooperative and refuse dental treatments
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 |
|---|---|---|
| ART dental sealantART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement | Other | ART dental sealant |
| Resin dental sealantResin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement | Other | Resin dental sealant |
| Sodium fluoride varnishTopical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months | Other | Sodium fluoride varnish |
| Silver fluoride solutionTopical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months | Other | Silver fluoride solution |
Primary outcome
dental caries
Time frame: 3 years
development of carious cavity after 3 years
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 11 Apr 2013.
- Derived from this study: PubMed 24886444Liu BY, Xiao Y, Chu CH, Lo EC. Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial. BMC Oral Health. 2014 May 19;14:54. doi: 10.1186/1472-6831-14-54.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Edward CM Lo principal investigator
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 Phase 2 study testing ART dental sealant, Resin dental sealant and Sodium fluoride varnish 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 2 inclusion and 2 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 11 Apr 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
dental caries (time frame: 3 years). 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 NCT01829334, 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 11 Apr 2013.