๐ฌIn plain words
What the trial is, and whether it could suit you
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 restora
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
Signed informed consent by the participant
Age 18 years or older
Indication for a Class III or Class IV resin-based composite (RBC) restoration on an anterior permanent tooth due to one or more of the following conditions:
Proximal carious lesion with cavitation
Defective restoration requiring replacement
Necessary proximal reshaping due to developmental anomalies (e.g., peg teeth, proximal gaps from Bolton discrepancies, orthodontic tooth position, or esthetic concerns like black triangles caused by periodontal tissue recession)
Vital teeth with regular sensitivity
Sufficient language skills to understand and comply with study procedures
Preoperative Visual Analog Scale (VAS) scores \< 3 for tooth sensitivity and biting discomfort
Good oral hygiene, including the ability to maintain effective oral hygiene
Clinical periodontal health (intact periodontium or a reduced periodontium due to non-periodontal causes or after periodontal treatment)
Exclusion Criteria:
Inability to achieve sufficient isolation and contamination control during restorative procedures
Class IV restoration required due to crown fracture, crown-root fracture, extensive tooth wear, or carious lesion affecting the incisal edge
Missing antagonist tooth without prosthodontic replacement
Intent to undergo professional tooth bleaching within five years following the Class III or IV restoration (Note: Professional tooth bleaching must be completed at least two weeks prior to study enrollment)
Known or suspected allergy to any constituents of the materials used (e.g., methacrylates or local anesthetics)
Pregnancy or lactation
Acute or chronic health conditions that may impair study participation (e.g., systemic diseases, oral conditions, or treatments that interfere with study procedures)
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What it tests
- Permanent dental restoration
University Center for Dental Medicine Basel UZB
Basel, Switzerland
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.