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NCT Number: NCT07212660

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

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.

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

N|DENT Zahnarztpraxis, Herzogenbuchsee, Canton of Bern, Switzerland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Postoperative pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Official study title

A Multi-center, Randomized-controlled, 12-month, Split-mouth, Non-inferiority Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy With a Flowable Bulk Fill Composite in Class I and II Deciduous Teeth

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 8, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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