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Effect of Phosphoric Acid Etching Duration on Direct Resin-Based Composite Restorations in Permanent Anterior Teeth

NCT06991842 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-08-05

No results posted yet for this study

Summary

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

Conditions

  • Dental Restoration, Permanent
  • Dental Caries (Disorder)
  • Dental Restoration Failure

Interventions

PROCEDURE

Permanent dental restoration

In 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.

Sponsors & Collaborators

  • Florin Eggmann

    lead OTHER

Principal Investigators

  • Florin Eggmann, PD Dr. med. dent. · University of Basel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2031-05-31
Completion
2031-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991842 on ClinicalTrials.gov