Use of Fissure Sealants 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.
Other: Fissure sealant
Other: Fissure sealants and fluoride varnish
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars|
- Number of healthy occlusal tooth surfaces of primary molars [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]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.
- Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Preventing occlusal caries
Comparing preventing effect of fissure sealants vs. fluoride varnish
Other: Fissure sealant
Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.
Other Names:Other: Fissure sealants and fluoride varnish
Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438866
|Kuwait, Hawally, Kuwait|
|Principal Investigator:||Sisko L Honkala, DDS, PhD||Faculty of Dentistry, Kuwait University|