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

March 24, 2026 updated by: Ivoclar Vivadent AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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).

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Canton of Bern
      • Herzogenbuchsee, Canton of Bern, Switzerland, 3360
        • Recruiting
        • N|DENT Zahnarztpraxis
        • Contact:
    • Canton of Lucerne
      • Willisau, Canton of Lucerne, Switzerland, 6130
        • Recruiting
        • Zahnarztpraxis Chrüzhof
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fast curing mode
Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).
Device: Fast curing mode
Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).
Other: Conventional curing mode
Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).
Device: Conventional curing mode
Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4-10 days after placement of the dental fillings

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivoclar Vivadent AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 1, 2025

First Submitted That Met QC Criteria

October 1, 2025

First Posted (Actual)

October 8, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTCS 369512033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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