An observational study in Chronic Apical Periodontitis, sponsored by Ataturk University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Ataturk University · Observational
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.
Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.
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Patients aged between 18 and 65 years who present with non-vital teeth showing negative responses to cold testing and electric pulp testing, negative responses to percussion and palpation tests, and radiographic evidence (via intraoral periapical radiography) of apical radiolucency with a Periapical Index (PAI) score of 3 or 4 in mandibular molar teeth will be included in the study.
Exclusion Criteria:
Saliva samples will be used for DNA isolation utilizing the QIAamp DNA Mini Kit. DNA quality will be assessed using a NanoDrop spectrophotometer. Allele-specific SNP genotyping assays will be loaded onto the Fluidigm 96.96 Dynamic Array IFC, and genotyping data will be analyzed using the BioMark Data Collection Software by calculating FAM and HEX signal intensities.
Also known as: SNP
genetic analysis of participant patients
This study is expected to contribute to a deeper understanding of the biological foundations of apical periodontitis and to support the development of personalized endodontic treatment approaches. Identifying the effects of single nucleotide polymorphisms (SNPs) related to inflammatory response and bone metabolism (IL1B, IL6, TNFA, RANKL, OPG) on periapical healing will help clarify why apical periodontitis exhibits different clinical courses among individuals.
Time frame: from enrollment to the 12 month follow-up
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Ataturk University