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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorIvoclar Vivadent AG

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fast curing mode
  • Conventional curing mode

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators