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Not Yet Recruiting NCT07788274

Zirconomer-P Versus RMGI for Proximal Restorations in Primary Molars

Conditions: Dental Caries

Sex: All
Ages: 4 Years – 7 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Cairo University

Location: Faculty of Dentistry, Cairo University -Pediatric Dentistry Department Clinic Cairo

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07788274). StuddyBuddy aggregates publicly available trial information.