Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

NCT ID: NCT04281433

Last Updated: 2020-02-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-02-01

Brief Summary

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electromyographic activity as well as clinical performance of bulk-Fill composite resins with Activa Bioactive Liner

Detailed Description

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Conditions

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Clinical Study of Activa Bioactive Restorative Dental 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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unilateral

Group Type EXPERIMENTAL

Activa Bioactive

Intervention Type OTHER

Before cavity preparation and restoration, masticatory muscles activity will be evaluated by using electromyography. An electromyography detects the electrical potential generated by muscle cells. A total of 40 posterior teeth will be selected for this study and grouped into 2 main groups (20 for each group)) according to presence of caries in one or both side in patient (unilateral or bilateral). Split mouth technique will be used. The affected teeth will be treated by removing the caries and restored tooth with bulk fill composite material, after restoring the affected teeth. Masticatory muscles activity will be evaluated by using electromyography to detect any changes in masticatory muscles activity before and after restoration.

bilateral

Group Type EXPERIMENTAL

Activa Bioactive

Intervention Type OTHER

Before cavity preparation and restoration, masticatory muscles activity will be evaluated by using electromyography. An electromyography detects the electrical potential generated by muscle cells. A total of 40 posterior teeth will be selected for this study and grouped into 2 main groups (20 for each group)) according to presence of caries in one or both side in patient (unilateral or bilateral). Split mouth technique will be used. The affected teeth will be treated by removing the caries and restored tooth with bulk fill composite material, after restoring the affected teeth. Masticatory muscles activity will be evaluated by using electromyography to detect any changes in masticatory muscles activity before and after restoration.

Interventions

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Activa Bioactive

Before cavity preparation and restoration, masticatory muscles activity will be evaluated by using electromyography. An electromyography detects the electrical potential generated by muscle cells. A total of 40 posterior teeth will be selected for this study and grouped into 2 main groups (20 for each group)) according to presence of caries in one or both side in patient (unilateral or bilateral). Split mouth technique will be used. The affected teeth will be treated by removing the caries and restored tooth with bulk fill composite material, after restoring the affected teeth. Masticatory muscles activity will be evaluated by using electromyography to detect any changes in masticatory muscles activity before and after restoration.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 18-40 years and cooperative patient.
* Good oral hygiene.
* Normal occlusal relation with normal dentition.

Exclusion Criteria

* Patient with severe medical problems.
* Tenderness with percussion or pre-operative pulpal pain.
* Mobile tooth and tooth with gingival recession.
* Pregnant or lactating females.
* Cracked teeth or teeth with deep periodontal pockets.
* Tooth with previous restoration.
* Allergy to resin materials.
* Defective restorations adjacent or opposing to tooth.
* Patient with bruxism
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ibrahim Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AlAzhar University, Faculty of Dentistry

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC16-051

Identifier Type: -

Identifier Source: org_study_id

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