A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth
A Multi-center, Randomized-controlled, 12-month, Split-mouth, Non-inferiority Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy With a Flowable Bulk Fill Composite in Class I and II Deciduous Teeth
Ivoclar Vivadent AG
70 participants
Dec 18, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Consent of a legal representative (usually parents)
- 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 Criteria8
- 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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Interventions
Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).
Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07212660