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Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

Primary Purpose

Clinical Study of Activa Bioactive Restorative, Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Activa Bioactive
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Study of Activa Bioactive Restorative

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AlAzhar University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

unilateral

bilateral

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Survival rate of restorative material
USPHS criteria

Full Information

First Posted
February 11, 2020
Last Updated
February 21, 2020
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04281433
Brief Title
Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
Official Title
Electromicrographic Activity as Well as Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Study of Activa Bioactive Restorative, Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
unilateral
Arm Type
Experimental
Arm Title
bilateral
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Activa Bioactive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electromyographic activity
Description
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)
Title
Electromyographic activity
Description
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
Title
Electromyographic activity
Description
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
Title
Electromyographic activity
Description
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 Outcome Measure Information:
Title
Survival rate of restorative material
Description
USPHS criteria
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
AlAzhar University, Faculty of Dentistry
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

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