Clinical Evaluation of Bioactive Injectable Resin Composite in Posterior Restorations

NCT ID: NCT05499494

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2024-03-31

Brief Summary

The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities

Detailed Description

Statement of the problem:

Marginal defects of composite fillings are often thought to be caused by poor adaptation of the restorative material to the cavity wall. To avoid these defects, particularly in posterior teeth, the use of flowable composites has been advocated because of their ability to 'wet' and adapt well to cavity margins and walls. However, flowable composites have a lower filler content and usually weaker mechanical properties than conventional composites.

The continued development of resin composites has led to formulations designed to further simplify the filling procedure, provide better mechanical properties, reduce the effect of polymerization shrinkage stresses and improve aesthetics. Recently, a new type of highly filled flowable composite has been developed. It is characterized by its high viscosity and is claimed to have improved mechanical properties not dissimilar from conventional composite restorative materials. This composite contains nano-sized filler particles, and due to its consistency, the material has been referred to as an 'injectable composite'.

Rationale for carrying out the trial:

The rationale of this study is to evaluate the mechanical performance of injectable composite resin against nanohybrid composites, because of its easy handling, time-saving, better margin adaptation, and the gain of extra mechanical properties at the same time.

Conditions

Dental Restoration Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

injectable composite

The material will be applied according to manufacturer instructions. BEAUTIFIL Flow Plus X will be applied directly into the cavity and create the shape desired in layers not exceeding 2 mm, and light cured for 20 seconds.

Group Type: EXPERIMENTAL

Beautifil Flow Plus X F00 injectable composite

Intervention Type: OTHER

bioactive injectable composite

Nanohybrid resin composite

The nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions.

Group Type: ACTIVE_COMPARATOR

Tetric N ceram resin composite

Intervention Type: OTHER

Nano hybrid resin composite

Interventions

Beautifil Flow Plus X F00 injectable composite

bioactive injectable composite

Intervention Type: OTHER

Tetric N ceram resin composite

Nano hybrid resin composite

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants:

1. Age range 20-50 years.

2. Males Or females .

3. Co-operative patients approving to participate in the trial.

• Teeth:

1. class I or II carious lesions premolars and molars.

2. Vital upper or lower teeth with no signs of irreversible pulpitis and pulpal necrosis.

3. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria

• Participants:

1. Patients with general systemic illness.

2. Allergic history against any component of used material.

3. Disabilities.

4. Pregnancy

5. Xerostomia.

6. Lack of compliance.

7. Evidence of parafunctional habits.

8. Temporomandibular joint disorders.

• Teeth:

1. Periapical pathology or signs of pulpal pathology.

2. Endodontically treated teeth.

3. Tooth hypersensitivity.

4. Possible prosthodontic restoration of teeth.

5. Heavy occlusion and occlusal contacts or history of bruxism.

6. Severe periodontal affection.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hazem Mohamed El Deriny

Assistant lecturer at operative dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mai Mamdouh, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of dentistry, Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Hazem Elderiny, M.SC

Role: CONTACT

hazem.elderiny@dentistry.cu.edu.eg

+201007775636

Yomna Khallaf, PhD

Role: CONTACT

Yomna.sayed@dentistry.cu.edu.eg

+201006781076

Facility Contacts

Mai Mamdouh, PhD

Role: primary

mai_mamdouh@dentistry.cu.edu.eg

+201066444572

Other Identifiers

Injectable resin composite

Identifier Type: -

Identifier Source: org_study_id