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.

April 14, 2026 updated by: KEZBAN MELTEM ÇOLAK, Ataturk University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Yakutiye
      • Erzurum, Yakutiye, Turkey (Türkiye)
        • Atatürk Üniversitesi Diş Hekimliği Fakültesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from enrollment to the 12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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