Dental CariesNCT01446107
Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
A study testing placement of fissure sealant, fluoride varnish and silver fluoride in people with Dental Caries, run by The University of Hong Kong at 1 site in China.
Trial summary
Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure… Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- placement of fissure sealant, fluoride varnish and silver fluoride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to Dec 2010
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- school children in good general health
- have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries
Who cannot join
- children with major systemic disease or taking long-term medications
- not cooperative or refuse dental treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.
- Conditions
- Dental Caries
- Being tested
- placement of fissure sealant, fluoride varnish, silver fluoride, placebo control
- Keywords
- tooth decay, fluoride, sealant, prevention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of fissure sealantOther
placement of resin-based fissure sealant at baseline without replacement
fluoride varnishOther
topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months
silver fluorideOther
topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year
placebo controlOther
application of water onto tooth surface every year
| Study group | Role | What they receive |
|---|---|---|
| fissure sealant | Experimental | single placement of resin fissure sealant on tooth surface Receives: Other: placement of fissure sealant |
| fluoride varnish | Experimental | application of a 5% sodium fluoride varnish every 6 months Receives: Other: fluoride varnish |
| SDF solution | Experimental | application of a 38% silver diamine fluoride solution onto tooth surface every year Receives: Other: silver fluoride |
| control | Placebo comparator | application of water onto tooth surface every year Receives: Other: placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental caries
tooth decay appearing as a cavity on tooth surface
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 posted5 Oct 2011 (estimated)
- Study startDec 2007
- Primary completionDec 2010
- Study completionDec 2010
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward CM Lo, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446107
- Sponsor's protocol ID
- UW06-402T/1427
- Status last verified
- Sep 2011
- First submitted
- 23 Sep 2011
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
PubMed 22736448
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
- ClinicalTrials.gov ID
- NCT01446107
- Acronym / sponsor ID
- UW06-402T/1427
- Conditions
- Dental Caries
- Keywords
- tooth decay, fluoride, sealant, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Oct 2011 (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.
Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fissure sealant | Experimental | Other: placement of fissure sealantsingle placement of resin fissure sealant on tooth surface |
| fluoride varnish | Experimental | Other: fluoride varnishapplication of a 5% sodium fluoride varnish every 6 months |
| SDF solution | Experimental | Other: silver fluorideapplication of a 38% silver diamine fluoride solution onto tooth surface every year |
| control | Placebo comparator | Other: placebo controlapplication of water onto tooth surface every year |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- school children in good general health
- have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries
Key exclusion criteria (2 listed)
- children with major systemic disease or taking long-term medications
- not cooperative or 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 |
|---|---|---|
| placement of fissure sealantplacement of resin-based fissure sealant at baseline without replacement | Other | fissure sealant |
| fluoride varnishtopical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months | Other | fluoride varnish |
| silver fluoridetopical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year | Other | SDF solution |
| placebo controlapplication of water onto tooth surface every year | Other | control |
Primary outcome
dental caries
Time frame: 3 years
tooth decay appearing as a cavity on tooth surface
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 3 May 2021.
- Derived from this study: PubMed 22736448Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
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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.
Edward CM Lo, PhD 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 study testing placement of fissure sealant, fluoride varnish and silver fluoride 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 3 May 2021. 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. 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?
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 NCT01446107, 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 3 May 2021.