Clinical Study on Reduced Exposure Times for Primary Tooth Fillings
Summary description of the study
In cases of treatable caries or defective dental fillings, a new composite filling (tooth-colored plastic filling material) is usually placed to achieve a naturally looking and fully functional dental restoration. The filling is cured by exposing the material to light after it has been placed in the cavity, causing the previously soft material to harden. In our research project, we investigate whether a reduced exposure duration (5 seconds) with increased light intensity (2000 mW/cm²) leads to the same clinical outcomes as the standard exposure (10 seconds, 1200 mW/cm²). The 5-second exposure mode has been successfully used for fillings in adults for years.
(BASEC)
Intervention under investigation
In our study, all participants will receive two dental fillings. One filling will be cured using the 5-second exposure mode (test group), and the other filling will be cured using the 10-second exposure mode (control group). The exposure duration for primary teeth is usually 10 seconds. In this study, we want to investigate whether fillings placed with the medical product Tetric plus Flow in primary teeth and cured for 5 seconds are effective and safe. For this purpose, aesthetic, functional, and biological parameters will be collected over an observation period of 1 year.
(BASEC)
Disease under investigation
treatable caries or defective dental filling
(BASEC)
-Age 4-9 years -Consent form from the legal guardian -2 primary molars requiring direct filling therapy (BASEC)
Exclusion criteria
-Sensitive teeth -Non-cooperative child -Allergies to materials used in the study (BASEC)
Trial sites
Other
(BASEC)
Herzogenbuchsee, Willisau
(BASEC)
Sponsor
Ivoclar Vivadent AG
(BASEC)
Contact
Contact Person Switzerland
Patrizia Elkuch-Hoch
+423 235 3780
patrizia.elkuch-hoch@clutterivoclar.comIvoclar Vivadent AG
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
23.10.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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 (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available