NCT05930548

Evaluation of Low-shrinkage Giomer Versus Resin-Modified Glass Ionomer in Cervical Caries Lesions: A Clinical Trial

Completed NA Last updated 19 June 2025

What this trial tests

NA trial testing Low Shrinkage Giomer in Caries, Cervical in 56 participants. Completed in 30 January 2025.

Timeline

1 September 2023

Primary endpoint
30 November 2024

30 January 2025

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	56
Start date	1 September 2023
Primary completion	30 November 2024
Estimated completion	30 January 2025
Sites	1 location across Egypt

Drugs / interventions tested

• Low Shrinkage Giomer

Conditions studied

• Caries, Cervical — all drugs for Caries, Cervical →

Sponsor

Cairo University

Who can join

Adults 25 to 50, any sex, with Caries, Cervical. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Management of cervical lesions presents serious problems with any restorative material. The two most common reasons for restoration failure are secondary caries at the tooth-restoration interface and loss of retention. Class V lesions often exhibit a low retentive cavity configuration (C-factor); which is responsible for marginal gaps around the restorations. Cervical margins -lying in either dentin or cementum- show unfavorable bonding performance, besides being usually subgingival where moisture control is difficult. The subgingival margin is not clinically desirable due to difficulty in cleaning and increased biofilm accumulation. Therefore, the selection of the restorative material can be challenging.

Resin composites are known for their high mechanical properties, excellent esthetic properties, and ease of clinical application. However, when compared with glass ionomers, resin composite has no cariostatic effect on tooth structure. In addition, microleakage caused by polymerization shrinkage of resin composite leads to plaque accumulation and secondary caries. On the other hand, resin-modified glass ionomer has many advantages, yet still it has lower weakness and esthetic properties compared to resin composite.

Based on current literature, there is limited evidence comparing clinical performance of low-shrinkage giomer resin composite to resin-modified glass ionomer in the treatment of cervical caries lesions.

This study is conducted to evaluate the clinical performance of low-shrinkage giomer resin composite versus resin-modified glass ionomer in treatment of cervical caries lesions, using both Modified USPHS and Revised FDI criteria. This study will be designed to test the null hypothesis that the low-shrinkage giomer resin composite will have the same clinical performance as resin-modified glass ionomer in cervical restorations, using both Modified USPHS and Revised FDI criteria.

Publications & conference data

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

1. Clinical performance and cost-effectiveness of low-shrinkage giomer resin composite versus resin-modified glass ionomer in cervical carious lesions: a 12-month randomized controlled trial.
   El Ghamrawy M, Kamal D, Hamza H. · · 2025 · PMID 40770630 · DOI 10.1186/s12903-025-06594-y