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

NCT ID: NCT04052802

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-30

Study Completion Date

2021-04-30

Brief Summary

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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

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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.

Conditions

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Demineralization, Tooth Demineralization, Fissure Non-Cavitated Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bioactive resin (Giomer)

This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures

Group Type EXPERIMENTAL

Fissure sealing

Intervention Type OTHER

The materials will be applied to the demineralized fissures as stated in manufacturer's instructions

Conventional resin

This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures

Group Type EXPERIMENTAL

Fissure sealing

Intervention Type OTHER

The materials will be applied to the demineralized fissures as stated in manufacturer's instructions

Interventions

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Fissure sealing

The materials will be applied to the demineralized fissures as stated in manufacturer's instructions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Khaled Mostafa

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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812014

Identifier Type: -

Identifier Source: org_study_id

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