Clinical Performance of BIS-GMA Free Dental Resin Composite

NCT ID: NCT05480852

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2022-07-06

Brief Summary

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.

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.

Conditions

Therapeutics

Keywords

Bis-GMA free dental resin composite; Bis-GMA containing dental resin composite; Clinical performance; Modified US Public Health Service Clinical Criteria (USPHS)

Study Design

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

Study Groups

Bis-GMA Free dental resin composite

Restorative Materials

Group Type: EXPERIMENTAL

Bis-GMA Free dental resin composite

Intervention Type: OTHER

Restorative Material

Bis-GMA containing dental resin composite

Restorative Materials

Group Type: ACTIVE_COMPARATOR

Bis-GMA Free dental resin composite

Intervention Type: OTHER

Restorative Material

Interventions

Bis-GMA Free dental resin composite

Restorative Material

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Have been from 20 to 45 years of age.
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Sara Ahmed Reda Mohamed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara A Reda, Phd

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Minia University

Locations

Sara Ahmed Reda Mohamed

Minya, , Egypt

Countries

Egypt

References

Reda SA, Hussein YF, Riad M. The impact of Bis-GMA free and Bis-GMA containing resin composite as posterior restoration on marginal integrity: a randomized controlled clinical trial. BMC Oral Health. 2023 Dec 19;23(1):1022. doi: 10.1186/s12903-023-03759-5.

Reference Type: DERIVED

PMID: 38114979 (View on PubMed)

Other Identifiers

Faculty of Dentistry

Identifier Type: -

Identifier Source: org_study_id