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Use of Fissure Sealants on Primary Molars

The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01438866
Enrollment
148
Registered
2011-09-22
Start date
2011-10-31
Completion date
2013-04-30
Last updated
2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Dental caries, Fissure sealant, Fluoride varnish, Primary molar

Brief 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. 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.

Interventions

OTHERFissure sealant

Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.

OTHERFissure sealants and fluoride varnish

Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars

Sponsors

Kuwait University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
42 Months to 52 Months
Healthy volunteers
Yes

Inclusion criteria

* positive written informed consent received from parents

Exclusion criteria

* if caries lesions in primary molars are so extensive that restorative treatment is needed

Design outcomes

Primary

MeasureTime frameDescription
Number of healthy occlusal tooth surfaces of primary molarsup to 1 yearOutcome 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.

Secondary

MeasureTime frameDescription
Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnishup to 1 yearOutcome 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.

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026