Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

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

Official Title
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Electromicrographic Activity as Well as Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

Conditions
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Clinical Study of Activa Bioactive Restorative, Dental Caries

Intervention / Treatment
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* Other: Activa Bioactive


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unilateral<br> | Other: Activa Bioactive<br>* 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.<br>|
| Experimental: bilateral<br> | Other: Activa Bioactive<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | after six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of restorative material | USPHS criteria | six months |