Clinical Performance of BIS-GMA Free Dental Resin Composite

NCT05480852 | Completed

• 1 other identifier: Faculty of Dentistry
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bis-GMA Free dental resin composite

EXPERIMENTAL

Restorative Materials

Other: Bis-GMA Free dental resin composite

Bis-GMA containing dental resin composite

ACTIVE COMPARATOR

Restorative Materials

Other: Bis-GMA Free dental resin composite

Interventions

Bis-GMA Free dental resin composite OTHER

Restorative Material

Bis-GMA Free dental resin composite; Bis-GMA containing dental resin composite

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Sara Ahmed Reda Mohamed

Minya, 61511, Egypt

Location

Related Publications (1)

• 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.

  PMID: 38114979 DERIVED

Study Officials

• Sara A Reda, Phd

  Faculty of Dentistry, Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: May 20, 2021
• Primary Completion: June 15, 2022
• Study Completion: July 6, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

EG (1)