NCT04281433 - Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

40

Conditions

Clinical Study of Activa Bioactive Restorative Dental Caries

Interventions

Activa BioactiveOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

AlAzhar University, Faculty of Dentistry

Cairo, Egypt

Outcomes

Primary Outcomes

Electromyographic activity

An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement

Time frame: baseline (immediate)

Electromyographic activity

An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement

Time frame: one week

Electromyographic activity

An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement

Time frame: after three months

Electromyographic activity

An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement

Time frame: after six months

Secondary Outcomes

Survival rate of restorative material

USPHS criteria

Time frame: six months