Chronic Apical PeriodontitisNCT07542223
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.
An observational study of Chronic Apical Periodontitis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Apical Periodontitis
- What is being tested?
- single nucleotide polymorphism
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Sep 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Üniversitesi Diş Hekimliği Fakültesi
Erzurum, Yakutiye
About this study
Official title: 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).
Read more
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.
- Conditions
- Chronic Apical Periodontitis
- Being tested
- single nucleotide polymorphism
- Keywords
- chronic apical periodontitis, Cone beam computed tomography, Single nucleotide polymorphism, Root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single nucleotide polymorphismGenetic
Also called SNP
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment to the 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KEZBAN MELTEM ÇOLAK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542223
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/980
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No