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Clinical Trials/NCT04052802
NCT04052802
Unknown
N/A

The Efficacy Of A Bioactive Resin Material Used As A Fissure Sealant As Compared To A Conventional Resin Regarding Its Retention, Marginal Integrity And Prevention Of Lesion Progression. A Randomized Clinical Study

Cairo University0 sites20 target enrollmentAugust 30, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Demineralization, Tooth
Sponsor
Cairo University
Enrollment
20
Primary Endpoint
Retention
Last Updated
6 years ago

Overview

Brief Summary

The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.

Detailed Description

Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers. The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.

Registry
clinicaltrials.gov
Start Date
August 30, 2019
End Date
April 30, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Khaled Mostafa

Researcher

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients with good oral hygiene
  • Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible

Exclusion Criteria

  • Medical Problems or Pregnancy
  • Lack of patient's approval and compliance
  • Presence of abnormal oral, medical, or mental condition
  • Known allergy of resin-based materials
  • Previous placements of sealants or restorations
  • Bruxism or mal-occlusion

Outcomes

Primary Outcomes

Retention

Time Frame: 18 months

The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.

Secondary Outcomes

  • Marginal integrity(18 months)
  • Caries progression(18 months)

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