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

Ivoclar Vivadent

Status: Not yet enrolling

Conditions: Dental Caries; Insufficient Dental Filling

Treatments: Device: Conventional curing mode; Device: Fast curing mode

Study type: Interventional

Funder types: Industry

Identifiers

NCT07212660

OTCS 369512033

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Fast curing mode

Experimental group

Description:

Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).

Treatment:

Device: Fast curing mode

Conventional curing mode

Other group

Description:

Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).

Treatment:

Device: Conventional curing mode