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.

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.

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Key information

Conditions

Chronic Apical Periodontitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Atatürk Üniversitesi Diş Hekimliği Fakültesi

Erzurum, Yakutiye, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single nucleotide polymorphism

Genetic

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.

Other names: SNP

Primary outcomes

genetic analysis of participant patients

Time frame: from enrollment to the 12 month follow-up

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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Relationship Between Genetic Polymorphisms and Healing of Periapical Lesions After Root Canal Treatment

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Apr 21, 2026
Registry last updated: Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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