Clinical trial NCT02933463: Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars
Official title: Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries
Keywords: children with high caries risk
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.

Detailed description: The aim of this study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace Wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.

PICO:

P: children aged 6-9 years old with high caries risk.

I: Embrace Wetbond.

C: Clinpro seal.

O:

Primary outcome: Retention of sealant; Device of measurement: questionnaire; unit: binary.

Secondary outcome: Retention and development of caries; Device of measurement: Modified simonsen's criteria; Unit: scoring system (0-4) tactile and visual examination.

Eligibility criteria: Inclusion Criteria:

* children aged 6-9 years
* children with high caries risk
* cooperative children
* fully erupted first permanent molars

Exclusion Criteria:

* children with hypoplastic teeth
* partially erupted
* uncooperative children
* children with carious molars.

Primary outcomes:
measure: Retention of sealant
timeFrame: 6 months
Secondary outcomes:
measure: Retention and development of caries
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mahmoud Hamdy, professor
role: STUDY_DIRECTOR
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