Status:
RECRUITING
Effect of Phosphoric Acid Etching Duration on Direct Resin-Based Composite Restorations in Permanent Anterior Teeth
Lead Sponsor:
Florin Eggmann
Conditions:
Dental Restoration, Permanent
Dental Caries (Disorder)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. I...
Detailed Description
This clinical trial, "Effect of Phosphoric Acid Etching Duration on the Performance of Direct Resin-Based Composite Restorations in Permanent Anterior Teeth: A Randomized Controlled Single-Center Tria...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06991842
Start Date
June 1 2025
End Date
December 31 2031
Last Update
August 5 2025
Active Locations (1)
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1
University Center for Dental Medicine Basel UZB
Basel, Canton of Basel-City, Switzerland, 4058