Status:
NOT_YET_RECRUITING
A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth
Lead Sponsor:
Ivoclar Vivadent AG
Conditions:
Dental Caries
Insufficient Dental Filling
Eligibility:
All Genders
4-9 years
Phase:
NA
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07212660
Start Date
December 1 2025
End Date
October 1 2027
Last Update
December 2 2025
Active Locations (2)
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1
N|DENT Zahnarztpraxis
Herzogenbuchsee, Canton of Bern, Switzerland, 3360
2
Zahnarztpraxis Chrüzhof
Willisau, Canton of Lucerne, Switzerland, 6130