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Completed

NCT Number: NCT04281433

Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

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

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Key information

Conditions

Clinical Study of Activa Bioactive Restorative Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AlAzhar University, Faculty of Dentistry

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Electromyographic activity

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Survival rate of restorative material

    Time frame: six months

    USPHS criteria

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 24, 2020
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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