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Recruiting NCT07212660

A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth

Trial Parameters

Condition Dental Caries
Sponsor Ivoclar Vivadent AG
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 4 Years
Max Age 9 Years
Start Date 2025-12-18
Completion 2026-11
Interventions
Fast curing modeConventional curing mode

Brief Summary

The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.

Eligibility Criteria

Inclusion Criteria: * Consent of a legal representative (usually parents) * 2 deciduous molars in the need of direct filling therapy class I and/or II in different quadrants (primary or secondary caries, filling loss) * Classification of caries: caries of all sizes in deciduous molars are included unless they can be treated with fissure sealing (ICDAS 3, 4, 5) * Sufficient language skills of legal representative and children * Teeth in the need of indirect pulp capping if necessary (Operator decision) Exclusion Criteria: * Cognitive impairment not age-appropriate * Sensitive tooth (pain at night, irritation-persistent pain, buccal swelling, percussion sensitivity) * Teeth with severely resorbed roots (anormal tooth mobility) * Direct pulp capping * Pulpotomy of an adjacent tooth in the same appointment * Noncompliant child * Allergies to material or anaesthetics used in the study * Sufficient isolation not possible

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