Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281433
• Other study ID #: REC16-051
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Study of Activa Bioactive Restorative
• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
Egypt	AlAzhar University, Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	Survival rate of restorative material	USPHS criteria	six months