Effect of Phosphoric Acid Etching Duration on Direct Resin-Based Composite Restorations in Permanent Anterior Teeth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorin Eggmann
About this trial
The goal of this clinical trial is to learn if reducing the phosphoric acid etching (PAE) time affects the performance of direct resin-based composite (RBC) restorations in permanent anterior teeth. It will also learn about the safety of using a shortened PAE protocol. The main questions it aims to answer are:
Does a shorter PAE time lead to more or less marginal staining in restored teeth?
What sensitivity or other clinical issues do participants experience after restoration using different PAE times?
Researchers will compare a reduced PAE protocol to a standard PAE protocol to see how each affects the outcome of Class III and IV anterior restorations.
Participants will:
Receive one or two direct RBC restorations using either a shortened or standard PAE protocol
Visit the clinic for follow-ups at baseline, and at 1, 2, 3, and 5 years after restoration
Have sensitivity and restoration quality evaluated using clinical exams, photographs, and questionnaires
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Permanent dental restoration
Procedure/SurgeryIn both study arms, permanent dental restorations are made with resin-based composite in permanent anterior teeth. Both study arms will use identical materials for the resin-based composite restoration (Tetric Plus Flow and Tetric Plus Fill) and universal adhesive (Adhese Universal), with the only difference being the duration of the phosphoric acid etching step. All other aspects of the restorative procedure, such as isolation of the operative field, application techniques, and final polishing, will remain consistent across both arms.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Standard PAE Protocol GroupActive comparator 1 intervention
Group B: Reduced PAE Duration Protocol GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of Marginal Staining in Direct Resin-Based Composite Restorations of Anterior Teeth
The primary outcome measure is the frequency of marginal staining in direct resin-based composite restorations placed in anterior permanent teeth, assessed at baseline and at 1, 2, 3, and 5 years post-restoration. Marginal staining will be evaluated using the Category A2 guideline from the FDI criteria. This outcome aims to determine if the duration of phosphoric acid etching affects the incidence of marginal staining over time.
Time frame
Baseline, 1, 2, 3, and 5 years post-restoration placementSecondary outcomes
1
Postoperative Sensitivity/Pulpal Status
Postoperative sensitivity will be assessed according to the FDI category B3 criterium.
Time frame
7-10 days post-restoration placement2
Fracture of material/retention
Fracture of material/retention will be assessed according to the FDI criterium F1.
Time frame
Baseline, 1, 2, 3, and 5 years post-restoration placement3
Marginal adaptation
Marginal adaptation will be assessed according to the FDI criterium F2.
Time frame
Baseline, 1, 2, 3, and 5 years post-restoration placement4
Proximal contact point
Proximal contact point will be assessed according to the FDI criterium F3.
Time frame
Baseline, 1, 2, 3, and 5 years post-restoration placementSponsors and contacts
Click on the lead sponsor to view all of their trials.
Florin Eggmann
Lead sponsor
University Hospital, Basel, Switzerland
Sponsor institution
Source ClinicalTrials.gov