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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Fast curing mode

    Device

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

  • Conventional curing mode

    Device

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Fast curing modeExperimental treatment 1 intervention
Group B: Conventional curing modeOther 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain

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.

Time frame
4-10 days after placement of the dental fillings

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.