Enamel Etching for Universal Adhesives: Examination of Enamel Etching Protocols for Optimization of Bonding Effectiveness.
J Wong, A Tsujimoto, N G Fischer...
https://pubmed.ncbi.nlm.nih.gov/31226005Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06991842
Effect of Phosphoric Acid Etching Duration on the Performance of Direct Resin-Based Composite Restorations in Permanent Anterior Teeth: A Randomized Controlled Single-Center Trial
Led by Florin Eggmann · Updated on 2025-08-05
66
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether reducing the phosphoric acid etching (PAE) time affects the performance and safety of direct resin-based composite (RBC) restorations in permanent anterior teeth. This randomized controlled trial compares a shorter PAE protocol to the standard protocol to determine differences in marginal staining and postoperative sensitivity in Class III and IV restorations. Participants receive one or two direct RBC restorations applied using either a reduced PAE duration of 10 seconds on enamel and dentin simultaneously or a standard etch-and-rinse protocol with longer etching times. Both groups receive the same universal adhesive and RBC materials, with restorations placed using a standardized layering technique and polished to finish. The trial includes follow-up visits at baseline (7-10 days post-op), and at 1, 2, 3, and 5 years after restoration. During these visits, researchers assess restoration quality and sensitivity using clinical exams, photographs, and questionnaires based on FDI criteria. Outcomes include marginal staining frequency, postoperative sensitivity, restoration surface characteristics, caries presence, and patient satisfaction. The study lasts approximately 6 years, with close monitoring to ensure safety and adherence to standardized restorative procedures.
CONDITIONS
Brief Title
Effect of Phosphoric Acid Etching Duration on Direct Resin-Based Composite Restorations in Permanent Anterior Teeth
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Signed informed consent by the participant
- Age 18 years or older
- Need for Class III or Class IV resin-based composite restoration on a permanent anterior tooth due to proximal carious lesion, defective restoration replacement, or necessary proximal reshaping
- Vital teeth with normal sensitivity
- Preoperative tooth sensitivity and biting discomfort less than 3 on the Visual Analog Scale (VAS)
- Good oral hygiene and clinical periodontal health
- Sufficient language skills to understand and follow study procedures
You will not qualify if you...
- Inability to achieve proper isolation and contamination control during restoration
- Class IV restorations due to fracture or extensive wear
- Missing opposing tooth without prosthodontic replacement
- Intention to undergo professional tooth bleaching within 5 years after restoration
- Known allergy to any materials used in the study
- Pregnancy or lactation
- Acute or chronic health conditions that impair participation or study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Treatment
Duration - Single visit for restoration placement
Participants receive one or two direct resin-based composite restorations on permanent anterior teeth using either a standard or reduced phosphoric acid etching protocol.
1 visit (in-person) for restoration procedure
Follow-up
Duration - Up to 5 years after restoration placement
Participants attend follow-up visits to assess restoration performance, sensitivity, and clinical outcomes through exams, photographs, and questionnaires.
Follow-up visits at 7-10 days (baseline), 1, 2, 3, and 5 years post-restoration
Trial Site Locations
Total: 1 location
1
University Center for Dental Medicine Basel UZB
Basel, Canton of Basel-City, Switzerland, 4058
Actively Recruiting
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Research Team
F
Florin Eggmann, PD Dr. med. dent.
R
Roland Weiger, Prof. Dr. med. dent.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effect of Reduced Phosphoric Acid Pre-etching Times on Enamel Surface Characteristics and Shear Fatigue Strength Using Universal Adhesives.
Akimasa Tsujimoto, Nicholas Fischer, Wayne Barkmeier...
https://pubmed.ncbi.nlm.nih.gov/28597008Effect of Over-Etching and Prolonged Application Time of a Universal Adhesive on Dentin Bond Strength.
Phoebe Burrer, Hoang Dang, Matej Par...
https://pubmed.ncbi.nlm.nih.gov/33287394Accuracy of Selective Enamel Etching: A Computer-assisted Imaging Analysis.
T Amran, D Meier, J Amato...
https://pubmed.ncbi.nlm.nih.gov/37635464