Dental CariesPhase 4NCT01438866
Use of Fissure Sealants on Primary Molars
A Phase 4 study testing Fissure sealant and Fissure sealants and fluoride varnish in people with Dental Caries, run by Kuwait University at 1 site in Kuwait.
Trial summary
Sealants have been shown to be the most effective caries preventive measure in permanent dentition. Sealants of the primary molars soon after they erupt would reduce the total caries experience of the primary teeth of the children and could possibly also postpone the caries process in the permanent dentition. Read more about this study
- Who is it for?
- Ages 42 to 52 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fissure sealant and Fissure sealants and fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteKuwait
- Study dates
- Oct 2011to Apr 2013
- Phase
- Phase 4
- 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 42 to 52 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- positive written informed consent received from parents
Who cannot join
- if caries lesions in primary molars are so extensive that restorative treatment is needed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars
Sealants have been shown to be the most effective caries preventive measure in permanent dentition. Sealants of the primary molars soon after they erupt would reduce the total caries experience of the primary teeth of the children and could possibly also postpone the caries process in the permanent dentition.
The aim of this study is to measure the caries preventive effect of sealants in primary molars. The specific objectives are: 1) to compare the number of new caries experience teeth and surfaces among the intervention group of 4-years old pre-school children during the 1 year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish on the caries experience on the occlusal surfaces of the primary molars and on the total caries experience of all the primary and permanent teeth, 3) to test the feasibility of the sealant program in one kindergarten in Kuwait city.
- Conditions
- Dental Caries
- Being tested
- Fissure sealant, Fissure sealants and fluoride varnish
- Keywords
- Dental caries, Fissure sealant, Fluoride varnish, Primary molar
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fissure sealantOther
Also called Brand name: Clinpro™ Sealant, Produced by: 3M ESPE, www.3MESPE.com/PrventiveCare, Brand name: DuraShield® 5% Sodium Fluoride Varnish
Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.
Fissure sealants and fluoride varnishOther
Also called ClinproTM (3M ESPE), DuraShield® (Sultan Healthcare)
Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars
| Study group | Role | What they receive |
|---|---|---|
| Preventing occlusal caries | Experimental | Comparing preventing effect of fissure sealants vs. fluoride varnish Receives: Other: Fissure sealant; Other: Fissure sealants and fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthy occlusal tooth surfaces of primary molars
Outcome will be measured by a clinical examination (dental caries status/ICDAS) one year after the fissure sealants and fluoride varnish have been applied. When a child has intact occlusal surfaces on primary molars in the baseline examination, s/he will get a fissure sealant on the other side of the mouth and fluoride varnish on the other side.
Measured: up to 1 year
Secondary outcomes (1)
Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish
Outcome will be measured by a clinical examination (dental caries status/ICDAS)one year after the fissure sealants and fluoride varnish have been applied. The effectiveness of these two preventive treatment will be compared, i.e. how many occlusal surfaces of primary molars stayed caries free with the sealant application vs. fluoride varnish application.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuwait University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sisko Honkala, Kuwait University
- Investigators
- Sisko L Honkala, DDS, PhD, Principal investigator, Faculty of Dentistry, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438866
- Sponsor's protocol ID
- DD03/10
- Status last verified
- Oct 2012
- First submitted
- 18 Sep 2011
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars
- ClinicalTrials.gov ID
- NCT01438866
- Acronym / sponsor ID
- DD03/10
- Conditions
- Dental Caries
- Keywords
- Dental caries, Fissure sealant, Fluoride varnish, Primary molar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Kuwait UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Sep 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.
Sealants have been shown to be the most effective caries preventive measure in permanent dentition. Sealants of the primary molars soon after they erupt would reduce the total caries experience of the primary teeth of the children and could possibly also postpone the caries process in the permanent dentition.
The aim of this study is to measure the caries preventive effect of sealants in primary molars. The specific objectives are: 1) to compare the number of new caries experience teeth and surfaces among the intervention group of 4-years old pre-school children during the 1 year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish on the caries experience on the occlusal surfaces of the primary molars and on the total caries experience of all the primary and permanent teeth, 3) to test the feasibility of the sealant program in one kindergarten in Kuwait city.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preventing occlusal caries | Experimental | Other: Fissure sealant, Other: Fissure sealants and fluoride varnishComparing preventing effect of fissure sealants vs. fluoride varnish |
Who may qualify
- Ages
- 42 to 52 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- positive written informed consent received from parents
Key exclusion criteria (1 listed)
- if caries lesions in primary molars are so extensive that restorative treatment is needed
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 |
|---|---|---|
| Fissure sealantAlso: Brand name: Clinpro™ Sealant, Produced by: 3M ESPE, www.3MESPE.com/PrventiveCare, Brand name: DuraShield® 5% Sodium Fluoride VarnishPreventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish. | Other | Preventing occlusal caries |
| Fissure sealants and fluoride varnishAlso: ClinproTM (3M ESPE), DuraShield® (Sultan Healthcare)Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars | Other | Preventing occlusal caries |
Primary outcome
Number of healthy occlusal tooth surfaces of primary molars
Time frame: up to 1 year
Outcome will be measured by a clinical examination (dental caries status/ICDAS) one year after the fissure sealants and fluoride varnish have been applied. When a child has intact occlusal surfaces on primary molars in the baseline examination, s/he will get a fissure sealant on the other side of the mouth and fluoride varnish on the other side.
1 secondary outcome
Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish
Time frame: up to 1 year
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 18 Mar 2014.
- Related InfoLink provided by the sponsor.
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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.
Sisko L Honkala, DDS, PhD principal investigator
Faculty of Dentistry, Kuwait University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fissure sealant and Fissure sealants and fluoride varnish in people with Dental Caries, run by Kuwait University at 1 site in Kuwait.
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 1 inclusion and 1 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 18 Mar 2014. 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 Kuwait. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of healthy occlusal tooth surfaces of primary molars (time frame: up to 1 year). 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 18 Mar 2014.