A 2-year Clinical Impact of Bulk-fill Low-viscosity Resin Composite Liners in Class II Restorations.

Two-Years Clinical Performance of Bulk-Fill High Viscosity Ormocer Versus Methacrylate-Based Resin Composite Restorative Systems: The Effect of Bulk-Fill Low-viscosity Resin Composite Liners in Class II Restorations.

This randomized clinical trial evaluated the clinical performance of class II resin composite restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2 years. The null hypotheses in the study were as follows: (1) Different types of matrix structures (ormocer vs. methacrylate) have no effect on the marginal integrity of restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not affect the marginal or internal adaptation of restorations.

Study Overview

• Status: Completed
• Conditions: Dental Caries Class II
• Intervention / Treatment: Combination product: Xtra-fill; Combination product: x-base; Combination product: Admira fusion x-tra; Combination product: Admira fusion x-base

Detailed Description

The study was designed following the Consolidated Standards of Reporting Trials (CONSORT) statement. approvement by the local ethics committee of Mansoura University code register was taken code M 11120520. The patients were selected as they searched for treatment in the Conservative Dentistry Department outpatient clinic, in the Faculty of Dentistry, Mansoura University. A group of 30 patients 21 Females and 9 males was chosen from among 92 participants after careful consideration of the inclusion and exclusion criteria. The sample size estimate was made based on the clinical success rate of posterior class II composite restorations observed in a prior study (97.5% at 24 months). The sample size needed per group was 23 teeth using a significance level of 0.05, power of 80%, and equivalency limit of 15%. A total of 30 patients were chosen, for a total of 120 restorations (30 for each group) after taking potential dropouts into account. To ensure adherence of the participants to the study, all volunteers underwent complete dental treatment and periodic follow-ups. The volunteers were contacted by telephone, WhatsApp message, Facebook, and e-mail for the assessments. Four attempts, including visits to the schools, were made to contact a volunteer before he/she was considered a "loss." both participants and examiners were blind to the interventions. An inter-examiner and intra-examiner agreement of at least 90% was requested before the beginning of the evaluation. Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 12 months, 18 months, and 24 months using the World Dental Federation (FDI) criteria.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura
    • Mansoura., Mansoura, Egypt, 35511
      • Mansoura U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients having at least 4 posterior teeth with moderate occlusal-proximal carious lesions.
• Patients ranging in age from 18 to 30 years.
• patients with normal occlusion.

Exclusion Criteria:

General exclusion criteria:

• Patients having severe chronic periodontitis.
• Patients with orthodontic appliances.
• Abnormal occlusion, parafunctional habits.
• Allergy to any of the materials used in the study. Specific teeth exclusion criteria
• Teeth with irreversible pulpitis or non-vital.
• Fractured or cracked teeth.
• Previously restored teeth.
• Cavities with isthmus larger than intercuspal distance.
• Teeth with deep sub-gingival cavity margins.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xtra-fill; Bulk-fill high-viscosity methacrylate-based resin composites.	Combination product: Xtra-fill; the material was placed in bulk.
Active Comparator: X-base; Bulk-fill low-viscosity methacrylate-based resin composites.	Combination product: x-base; The x-base liner was placed and then veneered with Xtra-fill.
Active Comparator: Admira fusion x-tra; Bulk-fill high-viscosity ormocer-based resin composites.	Combination product: Admira fusion x-tra; bulk placement of the restoration Admira fusion -xtra.
Active Comparator: Admira fusion x-base; Bulk-fill low-viscosity ormocer-based resin composites.	Combination product: Admira fusion x-base; Admira fusion x-base liner was used and then veneered by Admira fusion x-tra.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical performance	FDI criteria	two years

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Sa Mahmoud, professor, Operative Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): June 17, 2023

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: September 9, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: M 11120520

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