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

NCT ID: NCT07212660

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-10-31

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.

Detailed 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).

Conditions

Dental Caries; Insufficient Dental Filling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fast curing mode

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

Group Type: EXPERIMENTAL

Fast curing mode

Intervention Type: DEVICE

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

Conventional curing mode

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

Group Type: OTHER

Conventional curing mode

Intervention Type: DEVICE

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

Interventions

Fast curing mode

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

Intervention Type: DEVICE

Conventional curing mode

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

N|DENT Zahnarztpraxis

Herzogenbuchsee, Canton of Bern, Switzerland

Zahnarztpraxis Chrüzhof

Willisau, Canton of Lucerne, Switzerland

Countries

Switzerland

Facility Contacts

Klaus Neuhaus, Prof. Dr. med. dent.

Role: primary

klaus.neuhaus@unibe.ch

044 62 961 99 90

Eirini Stratigaki, Dr. med. dent.

Role: primary

estratigaki@icloud.com

044 41 970 37 55

Other Identifiers

OTCS 369512033

Identifier Type: -

Identifier Source: org_study_id