Zirconomer-P Versus RMGI for Proximal Restorations in Primary Molars

NCT07788274 | Not Yet Recruiting

• 1 other identifier: CU-PED-ZIR-RMGI-2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary molars; Proximal caries; Zirconomer-P; Zirconia-fortified glass ionomer; Resin-modified glass ionomer; RMGI; Dental restorations; Primary teeth; Pediatric dentistry; FDI criteria

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Functional Properties of Restorations According to the Revised FDI Criteria

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

Study Arms (2)

Zirconomer-P

EXPERIMENTAL

Participants assigned to this arm will receive zirconia-fortified glass ionomer (Zirconomer-P capsules) for restoration of proximal cavities in primary molars.

Combination Product: Zirconia-fortified glass ionomer

RMGI

ACTIVE COMPARATOR

Participants assigned to this arm will receive resin-modified glass ionomer (FX-Ultra) for restoration of proximal cavities in primary molars.

Combination Product: Resin-modified glass ionomer

Interventions

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.

Also known as: Zirconomer-P

Zirconomer-P

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.

Also known as: FX-Ultra

RMGI

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Posterior primary molar with a proximal carious lesion and no signs or symptoms of pulpal involvement.
• Bitewing radiograph showing the lesion extending to the outer one-third of dentin.
• Carious lesion classified as International Caries Detection and Assessment System (ICDAS) 3 or ICDAS 4.

You may not qualify if:

• Allergy to any restorative material.
• Patients undergoing orthodontic treatment with fixed appliances.
• Patients with debilitating systemic diseases.
• Children with special needs.
• Teeth with previous restorations.
• Periapical radiolucencies.
• Sensitivity to axial or lateral percussion.
• Mobile teeth.
• External or internal resorption.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University -Pediatric Dentistry Department Clinic

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Radwa Mohamed Galal, BDS, MSc

CONTACT

+201111831265; radwa.radwan@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Main Researcher

Model Details: Two parallel groups will be compared in a randomized clinical trial. Eligible participants will be randomly assigned to receive either zirconia-fortified glass ionomer (Zirconomer-P capsules) or resin-modified glass ionomer (FX-Ultra) for the restoration of proximal cavities in primary molars. Clinical outcomes will be assessed at baseline and during follow-up visits over 18 months.

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

EG (1)