Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04281433
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Clinical Study of Activa Bioactive Restorative; Dental Caries	Other: Activa Bioactive	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Electromicrographic Activity as Well as Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: unilateral	Other: 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.
Experimental: bilateral	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Electromyographic activity [baseline (immediate)]

   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

2. Electromyographic activity [one week]

   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

3. Electromyographic activity [after three months]

   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

4. Electromyographic activity [after six months]

   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

Secondary Outcome Measures

1. Survival rate of restorative material [six months]

   USPHS criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AlAzhar University, Faculty of Dentistry	Cairo		Egypt

Sponsors and Collaborators

• Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Ibrahim Ahmed, Principal Investigator, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT04281433
• Other Study ID Numbers: REC16-051
• First Posted: Feb 24, 2020
• Last Update Posted: Feb 24, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Feb 24, 2020