General information
  • Disease category Other (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel
    (BASEC)
  • Contact Florin Eggmann florin.eggmann@unibas.ch (BASEC)
  • Data Source(s) BASEC: Import from 23.04.2025 ICTRP: N/A
  • Last update 23.04.2025 07:40
HumRes66788 | SNCTP000006373 | BASEC2025-00584

How does the etching duration with phosphoric acid affect the behavior of tooth-colored composite fillings in anterior teeth? A clinical study

  • Disease category Other (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel
    (BASEC)
  • Contact Florin Eggmann florin.eggmann@unibas.ch (BASEC)
  • Data Source(s) BASEC: Import from 23.04.2025 ICTRP: N/A
  • Last update 23.04.2025 07:40

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)

Criteria for participation in trial
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)

not available

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@unibas.ch

UZB | 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
not available

Disease under investigation
not available

Intervention under investigation
not available

Type of trial
not available

Trial design
not available

Inclusion/Exclusion criteria
not available

not available

Primary and secondary end points
not available

not available

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