Deep Margin Elevation in Endodontically Treated Posterior Teeth (NCT07661719) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Deep Margin Elevation in Endodontically Treated Posterior Teeth
Turkey (Türkiye)45 participantsStarted 2026-03-24
Plain-language summary
This study aims to evaluate the periodontal response of proximal surfaces with deep margin elevation (DME) in endodontically treated posterior teeth restored with CAD/CAM systems. Deep subgingival margins present clinical challenges in terms of isolation, restoration, and long-term periodontal health.
DME is a minimally invasive technique used to relocate subgingival margins coronally to a supragingival level, facilitating adhesive procedures and CAD/CAM restoration placement. However, the periodontal effects of DME remain unclear.
In this prospective split-tooth clinical study, proximal surfaces treated with DME will be compared with control surfaces without DME within the same tooth. The primary outcome will be bleeding on probing (BOP), while secondary outcomes will include probing depth and plaque index. Clinical and radiographic evaluations will be performed at baseline and during follow-up.
The results of this study are expected to provide clinical evidence regarding the periodontal impact of DME and support clinical decision-making in the restoration of endodontically treated posterior teeth.
Who can participate
Age range
18 Years – 65 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 aged between 18 and 65 years
* Presence of at least one endodontically treated posterior tooth (premolar or molar) with extensive coronal structure loss
* Teeth indicated for indirect CAD/CAM restoration
* Presence of at least one proximal surface requiring deep margin elevation (subgingival margin)
* Opposing proximal surface with supragingival or equigingival margin suitable as control
* Good general health and ability to attend follow-up visits
* Signed informed consent
Exclusion Criteria:
* Patients with poor oral hygiene or uncontrolled periodontal disease
* Presence of active periodontal disease requiring treatment
* Teeth with mobility greater than Grade I
* Teeth with periapical pathology or unsuccessful endodontic treatment
* Patients with systemic diseases affecting periodontal health (e.g., uncontrolled diabetes)
* Pregnant or lactating women
* Patients using medications affecting gingival tissues (e.g., immunosuppressants, calcium channel blockers)
* Heavy smokers
* Patients unable to comply with follow-up schedule
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
Bleeding on Probing (BOP) Positive Surface Proportion
Timeframe: Baseline (1 week post-treatment), 6 months, and 12 months