Effect of an Additional Hydrophobic Adhesive Layer Application on the Class V Composite Restorations (NCT05635981) | Clinical Trial Compass
CompletedNot Applicable
Effect of an Additional Hydrophobic Adhesive Layer Application on the Class V Composite Restorations
Turkey (Türkiye)31 participantsStarted 2019-01-20
Plain-language summary
In restorative dentistry, to enhance bond strength between dentin and simplified adhesive systems, new materials or applications are constantly being developed all the time. In order to create a better hybrid layer quality, modifications are made to the chemical contents and application methods of the adhesives. For inhibition or slow down of collagen or resin matrix degradation at the adhesive interface, procedures like using protease enzyme inhibitors or additional hydrophobic layer applications are tested by in vitro and in vivo studies.
The main goal of this double-blind randomized clinical trial is to evaluate the 18-month clinical performances of two different one-step dentin adhesives that were applied alone or with an additional hydrophobic adhesive layer to non-carious cervical lesions.
The hypotheses are that (1) Additional Hydrophobic Adhesive layer application can provide better clinical performance in class V restorations and, (2) the HEMA content will cause statistically different clinical performances.
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:
* 18 and over 18 years old
* Having acceptable oral hygiene
* Good general health
* Having at least 20 teeth in occlusion
* Presence of at least 4 non-carious cervical lesions in the mouth that require treatment
* Lesions without caries
* Patient's consent to come to control appointments
* Vital and non-mobility of the tooth with the lesion
* During occlusion, the tooth with the lesion is in contact with the antagonist tooth.
Exclusion Criteria:
* Under 18 years old
* Having poor oral hygiene
* Poor general health condition
* Pregnancy or breastfeeding status
* Orthodontic application in the last 3 months
* The tooth with the lesion has pulpitis, mobility or it is non-vital
* Presence of advanced bruxism
* The tooth with the lesion is a prosthetic abutment
* Presence of advanced periodontitis or periodontal surgery in the last 3 months
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.