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

Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year and in Vitro Investigation of the Surface Roughness

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

Study Overview

• Status: Completed
• Conditions: Dental Restoration Failure
• Intervention / Treatment: Other: treatment of class two cavities

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: treatment of class two cavities; restorations in class 2 cavities
Active Comparator: Nano-hybrid Composite restoration.; applied to the cavity use the conventional incremental technique according to manufacturer instruction	Other: treatment of class two cavities; restorations in class 2 cavities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of restorations of class two cavities	Measured used FDI criteria	from one week to one year

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Study Director: Maha Niazy, PHD, Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Nano hybrid composite; Bioactive Giomer restoration
• Other Study ID Numbers: NTaher

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No