Effect of Restoration Margin Level in the Treatment of Gingival Recession Associated With Non-car… (NCT05682274) | Clinical Trial Compass
UnknownNot Applicable
Effect of Restoration Margin Level in the Treatment of Gingival Recession Associated With Non-carious Cervical Lesion
Turkey (Türkiye)40 participantsStarted 2021-10-01
Plain-language summary
The aim of this randomized, parallel-group clinical trial was to compare the 1-year periodontal, root coverage, esthetic, and patient-centered outcomes of the partial restoration placement with different apical margin levels combined with coronally advanced flap (CAF) plus connective tissue graft (CTG) in the treatment of isolated gingival recessions associated with non-carious cervical lesions (NCCL). Forty patients with single gingival recessions (RT1 gingival recessions and class B+ NCCL) were randomly allocated to either placement of restoration apical margin at the level of estimated cementoenamel junction (CEJ) or within 1 mm apical to the CEJ. Two weeks after the restorative treatment, all recession defects were treated with CAF combined with CTG. Periodontal measurements were taken at baseline, and 3, 6, and 12 months postoperatively. Patient-centered outcomes were evaluated at baseline, and 7, and 15 days, 6, and 12 months postoperative follow-ups. Modified root closure aesthetic score (mRES) was used to assess aesthetics at 6 and 12 months follow-ups.
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:
* Gingival recession of at least 1 mm depth.
* There is no loss of interdental support (RT-1)
* Cervical step greater than 0.5 mm
* Inability to detect CEJ (Class B+)
* Maximum root closure level at the NCCL's deepest point (Type 3)
* Individuals who do not have any systemic disease that would preclude surgery
* Who are not pregnant
* Who are not smokers or who smoke less than 5 cigarettes per day
* Who have a whole mouth plaque and bleeding score of 10%
* Patients who do not require endodontic treatment in the surgical area and do not have tooth mobility;
* Patients who do not require orthodontic treatment;
* Patients who do not have periodontal disease; and
* Patients who do not have restoration and/or filling in the recession area.
Exclusion Criteria:
* Smokers
* Pregnant
* Having a systemic disease that may deteriorate wound healing
* Poor oral hygiene
* Patients with active periodontal disease
* Tooth devitalization
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.