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

Not Applicable

Completed

• Conditions: Dental Restoration Failure
• Interventions: Other: treatment of class two cavities

• Registration Number: NCT06603116
• Lead Sponsor: Faculty of Dental Medicine for Girls

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

Study Timeline

• Study Start: 2022-11-15
• Primary Completion: 2022-11-22
• Study Completion: 2024-03-25
• Status Verified: 2024-09
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioactive Giomer restoration.	treatment of class two cavities	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
Nano-hybrid Composite restoration.	treatment of class two cavities	applied to the cavity use the conventional incremental technique according to manufacturer instruction

Primary Outcome Measures

Name	Time	Method
evaluation of restorations of class two cavities	from one week to one year	Measured used FDI criteria

Trial Locations

Locations (1)

Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt; 🇪🇬 Cairo, Egypt