Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

NCT04281433 | Completed DMC

• 1 other identifier: REC16-051
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Clinical Study of Activa Bioactive Restorative; Dental Caries

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Survival rate of restorative material

  six months

Study Arms (2)

unilateral

EXPERIMENTAL

Other: Activa Bioactive

bilateral

EXPERIMENTAL

Other: Activa Bioactive

Interventions

Activa Bioactive OTHER

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.

bilateral; unilateral

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between the ages of 18-40 years and cooperative patient.
• Good oral hygiene.
• Normal occlusal relation with normal dentition.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

AlAzhar University, Faculty of Dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 24, 2020
• Study Start: October 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

EG (1)