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

Not Applicable

Not yet recruiting

• Conditions: Dental Caries; Insufficient Dental Filling

• Registration Number: NCT07212660
• Lead Sponsor: Ivoclar Vivadent AG

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).

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-01
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2026-11
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pain	4-10 days after placement of the dental fillings	The assessment of postoperative pain will be done by using the Wong-Baker Faces Pain rating Scale and includes questions about type and duration of pain, intensity of pain and the type of stimulus causing the pain. Values of 0 and 2 in the Wong-Baker Faces Pain Rating Scale are considered as no pain and values \>2 as pain.

Trial Locations

Locations (2)

N|DENT Zahnarztpraxis; 🇨🇭 Herzogenbuchsee, Canton of Bern, Switzerland

Zahnarztpraxis Chrüzhof; 🇨🇭 Willisau, Canton of Lucerne, Switzerland