Use of Fissure Sealants on Primary Molars
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01438866|
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : March 18, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Other: Fissure sealant Other: Fissure sealants and fluoride varnish||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars|
|Study Start Date :||October 2011|
|Primary Completion Date :||March 2013|
|Study Completion Date :||April 2013|
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
- 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.
- Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish [ 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. 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438866
|Kuwait, Hawally, Kuwait|
|Principal Investigator:||Sisko L Honkala, DDS, PhD||Faculty of Dentistry, Kuwait University|