A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direc… (NCT07212660) | Clinical Trial Compass
RecruitingNot Applicable
A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth
Switzerland70 participantsStarted 2025-12-18
Plain-language 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.
Who can participate
Age range4 Years – 9 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Postoperative pain
Timeframe: 4-10 days after placement of the dental fillings