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NOT YET RECRUITING
NCT07788274
NA

Zirconomer-P Versus RMGI for Proximal Restorations in Primary Molars

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

Clinical trial comparing two tooth-colored restorative materials for treating cavities between the teeth of primary molars in children aged 4 to 7 years. The study will compare zirconia-fortified glass ionomer (Zirconomer-P) with resin-modified glass ionomer (RMGI) to evaluate their clinical performance, including the condition of the restoration, marginal adaptation, proximal contact, occlusion, wear, fracture, retention, and development of caries at the restoration margin. Children will be followed for up to 18 months after treatment

Official title: Clinical Evaluation of Zirconia Fortified Glass Ionomer Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

4 Years - 7 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09-30

Completion Date

2028-03-30

Last Updated

2026-08-26

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Zirconia-fortified glass ionomer

Zirconia-fortified glass ionomer (Zirconomer-P capsules) will be used to restore proximal carious cavities in primary molars. The material will be placed after selective removal of carious tissue and cavity preparation. Restorations will be clinically evaluated at baseline and at 3, 6, 12, and 18 months using the revised FDI criteria.

COMBINATION_PRODUCT

Resin-modified glass ionomer

Resin-modified glass ionomer (FX-Ultra) will be used as the restorative material for proximal carious cavities in primary molars. The material will be applied to the gingival seat and packed into the prepared cavity using a gold-plated applicator. Participants will be followed at baseline and at 3, 6, 12, and 18 months for clinical evaluation of the restoration.

Locations (1)

Faculty of Dentistry, Cairo University -Pediatric Dentistry Department Clinic

Cairo, Egypt