The Effect of Material Choice on Clinical Outcomes in Deep Margin Elevation (NCT07234266) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Material Choice on Clinical Outcomes in Deep Margin Elevation
Turkey (Türkiye)48 participantsStarted 2025-12-01
Plain-language summary
In dentistry, particularly in posterior teeth with extensive caries or old restorations, the extension of restoration margins below the gingival level presents a significant clinical challenge. In such cases, restorative procedures become more complicated, periodontal health may be adversely affected, and long-term tissue loss can occur. To overcome this problem, the "Deep Margin Elevation" technique has been developed. This approach aims to raise subgingival margins caused by caries or fractures above the gingival level, thereby providing a healthier and more favorable foundation for successful treatment.
In this study, two different materials will be used for deep margin elevation, followed by restoration of the teeth with indirect restorations fabricated using additive manufacturing technology, which has become increasingly popular in recent years. Two different additive manufacturing resins will also be applied in the restorative phase. The teeth treated with deep margin elevation and indirect restorations will be evaluated at baseline, 6 months, and 12 months according to the FDI criteria, as well as periodontal parameters due to the involvement of the gingival region.
This study aims to highlight the importance of material selection in restorative treatment planning and to scientifically demonstrate the impact of the applied technique on surrounding tissues. Furthermore, it will provide an evidence-based perspective on how adopting a tissue-friendly approach during restorative procedures may contribute to favorable long-term outcomes.
Who can participate
Age range
18 Years – 84 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:
* Patients who apply to Mersin University Faculty of Dentistry between 01.12.2025 and 01.03.2026 for restorative treatment of their teeth
* Patients aged between 18 and 84 years
* Patients without parafunctional habits (such as bruxism, clenching, or foreign object chewing)
* Vital or non-vital molar and premolar teeth with a clinical indication for inlay/onlay restoration
* Teeth with deep cavities and margins located at or slightly below the gingival level
* Defects limited to the occlusal surface and one proximal surface
* Occlusal defects extending beyond one-third of the distance between fissure and cusp tip, including at least one cusp
* Posterior teeth with an indication for deep margin elevation without violation of the biologic width
* Teeth with opposing natural teeth or fixed prosthetic restorations
* Teeth with the presence of adjacent proximal contacts
Exclusion Criteria:
* Teeth with fractures or cracks
* Patients with temporomandibular joint disorders
* Patients with malocclusion, bruxism, or parafunctional habits
* Posterior teeth without opposing natural teeth or fixed prosthetic restorations
* Posterior teeth without adjacent proximal contacts
* Patients with a history of allergy to the components of the restorative materials used
* Patients with severe gingival enlargement, gingival recession, or active periodontal disease
* Teeth requiring deep margin elevation that present with non-physiological mobility, fistula, or periapical lesi…
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.