Clinical Performance of BIS-GMA Free Dental Resin Composite

Clinical Performance of BIS-GMA Free Dental Resin Composite as Posterior Restoration: a Randomized Clinical Trial

Resin composites were introduced for restoring defective teeth commercially in the mid- 1960s as an alternative to acrylic resin and silicate cements. As one of the most significant contributions to dentistry, dental resin composites usually have three components as organic resin matrix, photo initiator system, and coupling agent treated inorganic fillers.

At present, the most commonly used organic resin matrix for dental resin composites are based on di-methacrrylates such as 2.2- bis [p-(2- hydroxy-3- methacryloxypropoxy) penylene] propane (Bis-GMA), ethoxylated bisGMA, 1,6-bis(2-methacryloyoxy-ethoxycarbonyl-amino)-2,4,4tri-methyl-hexane (UDMA) and triethyleneglycoldimethacrylate (TEGDMA).

The application of Bis-GMA has been doubted since it was reported to have estrogenic activity in a cell culture assay.Though later studies have showed that Bis-GMA does not hydrolyse into the estrogenic substance BPA, BPA has still been detected to be release out of several commercial Bis-GMA-based dental restorative materials. Although there is a lack of studies analysing the association between BPA exposure from dental materials and its adverse effects on human health, there is a need to develop newer BPA-free resin composites to minimize human exposure to this compound. Accordingly, the objective of this study was to evaluate the performance of BIS- GMA- free composite as a photopolymerizable posterior dental composite restoration.

Study Overview

• Status: Completed
• Conditions: Therapeutics
• Intervention / Treatment: Other: Bis-GMA Free dental resin composite

Detailed Description

Hypothesis: The null hypothesis is that there is no difference in using the new BIS- GMA- free composite.

Aim of the study: This clinical trial was conducted to compare the clinical performance of the new BIS- GMA- free composite versus BIS-GMA- containing composite in the management of carious lesion in adult patients over 9 months. The two types of composites will be evaluated using USPHS criteria for:

• Retention (R).
• Contact (C).
• Color match (CM).
• Marginal adaptation (MA).
• Marginal discoloration (MD).
• Anatomic form (AF).
• Secondary caries (SC).
• Surface texture (ST).
• Gingival inflammation (GI).
• Post-operative sensitivity (POS).
• Patient complaints (PC).
• Patient satisfaction (PS).
• The evaluation done by three calibrated operators.

The study was conducted in Operative Dentistry Department, Faculty of Dentistry, Menia University.

The researcher was bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining, and performing the procedures to them.

- Intervention:

BIS- GMA- free composite material:

Tooth preparation and restoration was carried out using magnifying loops. All cavities were restored using composite resin. cavities, including the dentin, were acid etched for 30 s, rinsed thoroughly for 15 s, bonded with universal adhesive and light cured for 10 s prior to placing the filling material.

Restorations were light cured for 20 s, check the occlusion, finished with diamond burs and polished with Kenda hybrid composite pre- and super-polishers (Kenda, Vaduz, Liechtenstein).

- Comparator:

BIS- GMA- containing composite material:

The same methodology of the intervention BIS-GMA- free composite material If the patient showed any complications during our clinical trial toward either the intervention (BIS- GMA- free composite) or the comparator (BIS-GMA containing composite material), the trial will be stopped at once and all the needed management against any complications will be done.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61511
    • Sara Ahmed Reda Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have been from 20 to 45 years of age.
• Have at least two molars supported permanent dentition free of any clinically significant occlusal interference who required class I or class II restoration and fulfilled the inclusion criteria, will informed about the study and will give a patient information leaflet (PIL) describing their potential involvement.
• The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
• The patient will be reimbursed for attending for the clinical evaluation(s) of their restorations.
• Be a regular dental attender who agree to return for assessments.

Exclusion Criteria:

• There was a history of any adverse reaction to clinical materials of the type to be used in the study.
• There was evidence of occlusal parafunction and/or pathological tooth wear.
• patients whose history revealed parafunctional habits or use of medications that potentially could cause hyposalivation.
• They are pregnant or have medical and/or dental histories which could possibly complicate their attendance for the assessment of the restorations and/ or influence the behavior and performance of the restorations in the clinical service.
• They were irregular dental attenders.

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: Bis-GMA Free dental resin composite; Restorative Materials	Other: Bis-GMA Free dental resin composite; Restorative Material
Active Comparator: Bis-GMA containing dental resin composite; Restorative Materials	Other: Bis-GMA Free dental resin composite; Restorative Material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the performance of BIS- GMA- free composite as a photopolymerizable posterior dental composite restoration versus BIS-GMA containing composite.	This clinical trial conducted to compare the clinical performance of the new BIS- GMA- free composite versus BIS-GMA- containing composite in the management of carious lesion in adult patients over 9 months. The two types of composites will be evaluated using USPHS criteria	9 months

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Sara A Reda, Phd, Faculty of Dentistry, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Bis-GMA free dental resin composite; Bis-GMA containing dental resin composite; Clinical performance; Modified US Public Health Service Clinical Criteria (USPHS)
• Other Study ID Numbers: Faculty of Dentistry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No