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Clinical Trials/NCT04560985
NCT04560985
Unknown
Not Applicable

Clinical Evaluation of Retention for Hydrophilic and Hydrophobic Resin-Based Sealants in Uncooperative Children: A Randomized Controlled Clinical Trial

King Abdulaziz University0 sites42 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries
Sponsor
King Abdulaziz University
Enrollment
42
Primary Endpoint
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Last Updated
5 years ago

Overview

Brief Summary

To evaluate and compare the retention and cariostatic effect of hydrophilic and hydrophobic resin-based sealants for sealing pits and fissures of permanent molars in uncooperative children.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
January 1, 2024
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hussein A. Alharthy

Postgraduate student

King Abdulaziz University

Eligibility Criteria

Inclusion Criteria

  • Children with good health and without any systematic diseases history which may interfere with their oral hygiene.
  • Children ranging in age from 6 to 9 years.
  • Children with bilateral fully erupted mandibular first permanent molars with deep fissures having a score of 0 following the International Caries Detection and Assessment System II (ICDAS II).
  • Uncooperative children with "definitely negative" or "negative" behavioral ratings according to the Frankl behavior classification scale.
  • Informed consent to the child's participation in the study signed by one of his/her parents/guardian.
  • No children will be excluded on the basis of gender, race, social or economic status

Exclusion Criteria

  • Children with systemic diseases.
  • Children with oral habits affecting occlusion.
  • Children with any physical or mental disorders.
  • Children with cavitated, defected, missed or restored contralateral tooth.
  • Children with history of allergy to resin or latex.
  • Teeth with restorations, cavitated lesion, hypoplasia and any developmental defects.
  • Not approving to sign the consent.

Outcomes

Primary Outcomes

Sealant retention scoring using Color, Coverage and Caries (CCC) system

Time Frame: At 36 months

Secondary Outcomes

  • Caries scoring using Color, Coverage and Caries (CCC) system(At 36 months)

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