Zirconomer-P Versus RMGI for Proximal Restorations in Primary Molars

ConditionDental Caries

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age4-7

SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Generally cooperative children who can be managed by the operators.

Parent/legal guardian willing to sign the informed consent.

Acceptance of the required follow-up period.

Moderate to low caries risk according to the Cariogram application.

Disqualifiers

Allergy to any restorative material.

Patients undergoing orthodontic treatment with fixed appliances.

Patients with debilitating systemic diseases.

Children with special needs.

Trial design

Design model

Parallel

Treatments tested in this trial

Zirconia-fortified glass ionomer
Combination product
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.
Resin-modified glass ionomer
Combination product
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Zirconomer-PExperimental treatment 1 intervention

Group B: RMGIActive comparator 1 intervention

Trial outcomes

Primary outcomes

Biological Properties of Restorations According to the Revised FDI Criteria

Assessment of biological properties of the restorations, including caries at the restoration margin, dental hard tissue defects at the restoration margin, and postoperative hypersensitivity/pulp status using the revised Fédération Dentaire Internationale (FDI) criteria.

Time frame

Baseline, 3, 6, 12, and 18 months after restoration

Secondary outcomes

Functional Properties of Restorations According to the Revised FDI Criteria

Assessment of the functional properties of the restorations, including marginal adaptation, proximal contact point, form and contour, occlusion and occlusal wear, fracture of the restorative material, and retention, using the revised Fédération Dentaire Internationale (FDI) criteria.

Time frame

Baseline, 3, 6, 12, and 18 months after restoration

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: