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
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