Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02933463
Collaborator
(none)
32
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Embrace Wetbond
  • Other: Clinpro sealant
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars, Randomized Clinical Trial
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: embrace wetbond sealant

moisture tolerant resin based, have same properties of other sealant

Other: Embrace Wetbond
not require an additional bonding agent hydrophilic, fluoride releasing

Active Comparator: clinpro sealant

is a dental resin, with low viscosity , fluoride releasing with a unique patented color change.

Other: Clinpro sealant

Outcome Measures

Primary Outcome Measures

  1. Retention of sealant [6 months]

    device for measurement: will make a questionnaire for the patients , unit of measurement: binary ( yes/no)

Secondary Outcome Measures

  1. Retention and development of caries [6 months]

    device of measurement: simonsen's criteria, unit of measurement: scoring system from 0-4 by tactile and visual examination.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 9 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Mahmoud Hamdy, professor, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Noha Abdullah agina, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT02933463
Other Study ID Numbers:
  • Nagina
First Posted:
Oct 14, 2016
Last Update Posted:
Nov 1, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Noha Abdullah agina, Principal Investigator, Cairo University

Study Results

No Results Posted as of Nov 1, 2016