Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year

NCT ID: NCT06603116

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-03-25

Brief Summary

Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer

Detailed Description

• Patients will be selected according to the following inclusion and exclusion criteria from the outpatient Operative clinic, Faculty of Dental Medicine for Girls, Al-Azhar University.
• The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials and techniques. A written informed consent form will be signed from patients prior to study initiation.
• Co-operative patients of age range 20-30 years old with no gender prediction, The patients will be divided into two groups Group (1): Bioactive Giomer restoration. Group (2): Nano-hybrid Composite restoration. Restoration will be evaluated using FDI criteria (functional and biological properties) All the restorations will be clinically evaluated after 1 week (baseline),3 month, 6 months,12 months.

data collected and statistically analyzed

Conditions

Dental Restoration Failure

Study Design

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

Study Groups

Bioactive Giomer restoration.

material applied according to manufacturer instructions. BEAUTIFIL II LS 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

treatment of class two cavities

Intervention Type: OTHER

restorations in class 2 cavities

Nano-hybrid Composite restoration.

applied to the cavity use the conventional incremental technique according to manufacturer instruction

Group Type: ACTIVE_COMPARATOR

treatment of class two cavities

Intervention Type: OTHER

restorations in class 2 cavities

Interventions

treatment of class two cavities

restorations in class 2 cavities

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • Each patient should have at least two proximal carious lesions on both sides in the posterior teeth.

• Adjacent and opposing natural teeth should be present.
• Patient should be willing to return for follow-up examination and evaluation.

Exclusion Criteria

• • Patient with poor oral hygiene and motivation.

• Patient with unrealistic expectations.
• Patients with disabilities, systemic diseases or severe medically compromised, bruxism, clenching or temporomandibular joint disorders and patients with allergy to any components of the materials.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Faculty of Dental Medicine for Girls

OTHER_GOV

Sponsor Role: lead

Responsible Party

Noha Taher

Assistant lecturer at operative department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha Niazy, PHD

Role: STUDY_DIRECTOR

Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt

Locations

Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt

Cairo, , Egypt

Countries

Egypt

Other Identifiers

NTaher

Identifier Type: -

Identifier Source: org_study_id