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临床试验/NCT07542223
NCT07542223进行中(未招募)不适用

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

Ataturk University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
96
试验地点
1
主要终点
genetic analysis of participant patients

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.)

排除标准

  • 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

结局指标

主要结局

genetic analysis of participant patients

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Ataturk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

KEZBAN MELTEM ÇOLAK

prof.dr.

Ataturk University

研究点 (1)

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