The Aim of This Study is to Evaluate the Relationship Between Genetic Polymorphisms and Periapica… (NCT07542223) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Aim of This Study is to Evaluate the Relationship Between Genetic Polymorphisms and Periapical Lesion Healing in Individuals With Chronic Apical Periodontitis at Clinical and Radiological Levels.
Turkey (Türkiye)96 participantsStarted 2026-02-01
Plain-language summary
Chronic apical periodontitis is a chronic inflammatory condition characterized by periapical tissue destruction and alveolar bone resorption as a result of the host response to pulpal infection, often presenting asymptomatically. The aim of this study is to comprehensively evaluate the relationship between genetic polymorphisms and periapical lesion healing in individuals with chronic apical periodontitis at clinical and radiological levels. Despite standardized root canal treatment protocols, variability in healing outcomes among individuals suggests a potential role of genetic factors in this process.
This prospective observational study will include patients diagnosed with chronic apical periodontitis based on clinical and radiographic findings. All participants will undergo standardized endodontic treatment. At baseline, periapical radiography and cone-beam computed tomography (CBCT) will be performed to enable three-dimensional volumetric assessment. Follow-up evaluations will be conducted at 6 months with clinical examination and periapical radiography, and at 12 months with repeat CBCT imaging to assess volumetric changes in lesion size. All radiographic procedures will be performed in accordance with the ALARA principle, using an endodontic field of view (FOV).
Prior to treatment, saliva samples will be collected for DNA isolation, and single nucleotide polymorphisms in selected cytokine gene regions will be analyzed. The primary outcome measure will be the change in periapical lesion volume over time, which will be statistically evaluated in relation to genetic profiles.
This comprehensive approach is expected to enhance the understanding of healing mechanisms in apical periodontitis, improve the predictability of treatment outcomes, and contribute to the development of personalized, risk-based treatment strategies in endodontic practice.
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
* Devital mandibular molar teeth with asymptomatic apical periodontitis
* Teeth showing negative response to percussion and palpation tests
* Teeth with negative responses to cold test and electric pulp testing
* Teeth with a Periapical Index (PAI) score of 3 or 4
* Patients classified as ASA I
* Patients without any genetic disorders (e.g., Down syndrome, congenital insensitivity to pain, etc.)
Exclusion Criteria:
* Teeth with internal or external resorption
* Teeth with a history of trauma
* Teeth with vertical or horizontal root fractures
* Teeth with grade 3 mobility and loss of function
* Teeth that cannot be isolated with rubber dam or are not restorable
* Pregnant women or patients with suspected pregnancy
* Root canal curvature greater than 25° according to Schilder's classification
* Patients with generalized periodontitis
* Presence of periodontal pocket depth greater than 3 mm in the involved tooth
* Patients classified as ASA II or higher
* Presence of preoperative swelling, sinus tract, or pain on palpation
* Patients with bruxism
* Teeth with suspected periodontal-endodontic lesions
* Teeth with a PAI index below 2 or above 5
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
genetic analysis of participant patients
Timeframe: from enrollment to the 12 month follow-up