NCT05480852

Clinical Performance of BIS-GMA Free Dental Resin Composite

Completed NA Last updated 29 July 2022

What this trial tests

NA trial testing Bis-GMA Free dental resin composite in Therapeutics in 40 participants. Completed in 6 July 2022.

Timeline

20 May 2021

Primary endpoint
15 June 2022

6 July 2022

Quick facts

Lead sponsor	Minia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	20 May 2021
Primary completion	15 June 2022
Estimated completion	6 July 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Bis-GMA Free dental resin composite

Conditions studied

• Therapeutics — all drugs for Therapeutics →

Sponsor

Minia University

Who can join

Adults 20 to 45, any sex, with Therapeutics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The impact of Bis-GMA free and Bis-GMA containing resin composite as posterior restoration on marginal integrity: a randomized controlled clinical trial.
   Reda SA, Hussein YF, Riad M. · · 2023 · cited 8× · PMID 38114979 · DOI 10.1186/s12903-023-03759-5