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

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.

Dental interventions in young children are challenging due to limited compliance and anxiety. Moisture control during the placement of resin composite fillings is particularly difficult, as children need to remain calm. Reducing treatment time benefits both children and dentists.

The planned clinical investigation aims to evaluate the clinical performance and safety of posterior restorations on primary teeth using a flowable composite with a fast curing mode (5 seconds, 2000 mW/cm²) compared to a conventional curing mode (10 seconds, 1200 mW/cm²).

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