Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin

Not Applicable

• Conditions: Demineralization, Fissure; Demineralization, Tooth; Non-Cavitated Caries
• Interventions: Other: Fissure sealing

• Registration Number: NCT04052802
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-09
• Last Update Submitted: 2019-08-09
• Study First Posted: 2019-08-12
• Last Update Posted: 2019-08-12
• Study Start: 2019-08-30
• Primary Completion: 2021-03-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioactive resin (Giomer)	Fissure sealing	This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures
Conventional resin	Fissure sealing	This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures

Primary Outcome Measures

Name	Time	Method
Retention	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 Outcome Measures

Name	Time	Method
Marginal integrity	18 months	The materials margins will be assessed for their marginal seal using FDI criteria using a WHO probe. Scoring will be made from 1-5 by FDI criteria then statistically analyzed
Caries progression	18 months	The demineralized fissures will be monitored for caries arrest or progression. The assessment will be made by ICDAS II criteria comparing the scores from baseline.