Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04281433

Enrollment

Registered

2020-02-24

Start date

2019-10-01

Completion date

2020-02-01

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Study of Activa Bioactive Restorative, Dental Caries

Brief summary

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

Interventions

OTHERActiva 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
Survival rate of restorative material	six months	USPHS criteria

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026