Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars (NCT06643676) | Clinical Trial Compass
CompletedNot Applicable
Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars
India70 participantsStarted 2024-07-01
Plain-language summary
Targeted endodontic microsurgery represents precise and advanced approach to resolving persisting chronic periapical periodontitis after non- surgical root canal treatment. This specialised procedure involves accessing the root tip of the tooth under high magnification using dental operating microscopes and employing microsurgical instruments to remove infected or inflamed tissue, as well as any pathological lesions present in the periapical region. Targeted Endodontic Microsurgery is useful for osteotomy and root- end resection when exacting control of depth, diameter, and angulation of osteotomy and root end resection is necessary. Using a CBCT(cone beam computed tomography) designed 3D - printed surgical guideis a more accurate method for access to the apical portion of the root during surgical endodontics compared with a "freehand" CBCT - approximated conventional method. These guided have the potential to increase accuracy and precision and to reduce intraoperative time as well as postoperative complications. Additionally, it provides a viable treatment option for patients who may not be candidates for traditional root canal therapy or retreatment due to anatomical complexities or previous treatment failures.
Who can participate
Age range
18 Years – 55 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 in which non-surgical retreatment is unfeasible (post, anatomical complexity, iatrogenic errors) or previously failed treatment.
* Patients with persistent symptomatic apical periodontitis and periapical radiolucency.
* Tooth with a peri-radicular lesion of strictly endodontic origin (chronic apical periodontitis) and combined endodontic periodontic lesions with the size of lesion ≥5mm.
Patients between 18-55 years of age.
* No general medical contraindications for oral surgical procedures (ASA-1 and ASA-2 according to the classification of the American Society of Anesthesiologists)
* ASA 1- A normal healthy patient. Example: Fit, nonobese (BMI under 30), nonsmoking patient with good exercise tolerance.
* Tooth with adequate final restoration without clinical evidence of coronal leakage.
* No spontaneous pain or swelling.
* Good periodontal health condition at tooth level
* Able to completely understand and sign an informed consent form
Exclusion Criteria:
* Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders)
* Patients on anticoagulant/ antiplatelet drugs.
* Fractured/perforated teeth.
* Teeth with deep pockets (probing depth \> 4 mm).
* Presence of vertical root fracture.
* Miller class III/IV mobility.
* Pregnancy.
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
Quality of life following periapical surgery
Timeframe: 1 year
Trial details
NCT IDNCT06643676
SponsorPostgraduate Institute of Dental Sciences Rohtak