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Zirconomer-P Versus RMGI for Proximal Restorations in Primary Molars

NCT07788274 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-28

No results posted yet for this study

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.

Conditions

  • Dental Caries

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-03-30
Completion
2028-03-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788274 on ClinicalTrials.gov