How does the etching duration with phosphoric acid affect the behavior of tooth-colored composite fillings in anterior teeth? A clinical study
Summary description of the study
When providing a tooth with a composite filling, the tooth must be pre-treated. The pre-treatment ensures that the filling adheres well to the tooth. The standard pre-treatment of the tooth is done by applying a special gel for a short time. This gel contains phosphoric acid. Currently, it is unclear what the optimal exposure time of the phosphoric acid gel is. In this clinical study, we investigate how the duration of the exposure time of the phosphoric acid gel affects the susceptibility of the fillings to marginal discoloration. Furthermore, we examine how the anterior tooth fillings behave over time in this study.
(BASEC)
Intervention under investigation
In our study, participants are randomly assigned to groups. This is important to obtain reliable results from the study. Each group receives a different treatment. In our study, there are 2 groups:
- Group 1 (Experimental group): In this group, the phosphoric acid gel is applied simultaneously to the enamel (the outer layer of the tooth) and the dentin (the tooth substance located beneath the enamel). The exposure time of the gel is a total of 10 seconds on both the enamel and the dentin.
- Group 2 (Control group): In this group, the phosphoric acid gel is first applied to the enamel and only shortly thereafter to the dentin. The exposure time of the gel is 15-30 seconds on the enamel and 10-15 seconds on the dentin.
(BASEC)
Disease under investigation
Adults often have anterior teeth that require a composite filling. Such a composite filling may be necessary due to caries (a 'cavity' in the tooth), a defective filling that needs to be replaced, or due to a desired shape change of an anterior tooth. When a composite filling is needed, one typically receives a tooth-colored composite filling.
(BASEC)
18 years old or older Need for an anterior tooth filling Tooth with a healthy dental nerve (BASEC)
Exclusion criteria
Tooth unsuitable for a composite filling Tooth defect due to an accident, where the incisal edge was also damaged Allergy to components of composite fillings (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
UZB | University Center for Dental Medicine Basel Department of Periodontology, Endodontology, and Cariology University of Basel Mattenstrasse 40 CH-4058 Basel
(BASEC)
Contact
Contact Person Switzerland
Florin Eggmann
+41 61 267 26 80
florin.eggmann@clutterunibas.chUZB | University Center for Dental Medicine Basel Department of Periodontology, Endodontology, and Cariology University of Basel Mattenstrasse 40 CH-4058 Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
22.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Effect of Phosphoric Acid Etching Duration on the Performance of Direct Res-in-Based Composite Restorations in Permanent Anterior Teeth: A Randomized Controlled Single-Center Trial (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available