Clinical Performance of Different Adhesive Strategies With a Universal System in Sclerosed Dentin… (NCT05211908) | Clinical Trial Compass
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Clinical Performance of Different Adhesive Strategies With a Universal System in Sclerosed Dentin in NCCL: A Double-blind Randomized Clinical Trial.
Brazil50 participantsStarted 2021-07-27
Plain-language summary
The aim of this randomized, prospective, parallel, double-blind clinical trial will be to evaluate the clinical performance of restorations performed in non-carious cervical lesions (NCCL) using a soft ph universal adhesive system, varying the adhesive strategy (self-etching vs. selective etching of the enamel) and the sclerosis characteristics of the dentinal substrate over 24 months.
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:
* Good general health status
* Good oral hygiene
* Absence of periodontal disease
* Minimum of 20 teeth in occlusion
* Presence at least one (01) non-carious cervical lesion in a tooth with pulp vitality.
* Non-carious cervical lesion greater than 1mm in depth.
* Non-carious cervical lesion involving enamel and dentin.
Exclusion Criteria:
* Non- carious cervical lesion cavo surface margin involving more than 50% of the enamel.
* NCCL in crack teeth.
* Absence of opposing teeth and/or adjacent to the lesion.
* Presence of occlusal trauma in the NCCL tooth
* Presence of orthodontic appliance or removable partial denture with retention in the tooth where the lesion is located
* Patients that underwent tooth whitening procedures within a period of less than 14 days from the date of restoration
* Patients with high risk of caries (presence of three or more active caries lesions)
* Xerostomia
* Bruxism
* Pregnant women
* Patients who do not accept the study conditions
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.