Effect of Phosphoric Acid Etching Duration on Direct Resin-Based Composite Restorations in Perman… (NCT06991842) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Phosphoric Acid Etching Duration on Direct Resin-Based Composite Restorations in Permanent Anterior Teeth
Switzerland66 participantsStarted 2025-06-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Marginal Staining in Direct Resin-Based Composite Restorations of Anterior Teeth
Timeframe: Baseline, 1, 2, 3, and 5 years post-restoration placement