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临床试验/NCT07697300
NCT07697300已完成不适用

The Relationship Between COMT, MAOA, and SLC6A4 Polymorphisms and the Success of Inferior Alveolar Nerve Block

Marmara University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2025年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Success of Inferior Alveolar Nerve Block Anesthesia

研究概览

简要总结

The purpose of this study was to evaluate the association between COMT, MAOA, and SLC6A4 genetic polymorphisms and the success of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular molars. Patients presenting with moderate to severe pain were enrolled. Before anesthesia, pain intensity was assessed using the Heft-Parker Visual Analog Scale (HP-VAS), and pulpal vitality was evaluated using cold and electric pulp tests. All participants received a standardized inferior alveolar nerve block with 4% articaine containing epinephrine. Fifteen minutes after injection, pulpal anesthesia was reassessed using cold and electric pulp tests. Patients who continued to respond to these tests were considered to have unsuccessful pulpal anesthesia and were excluded from the study. Patients with no response to either test were included in the study, and root canal treatment was initiated. Pain experienced during the procedure was assessed using the HP-VAS. Buccal swab samples were collected for genomic DNA isolation, and COMT, MAOA, and SLC6A4 polymorphisms were analyzed using a Real-Time PCR-based TaqMan genotyping assay. The association between genetic polymorphisms and the success of inferior alveolar nerve block was statistically evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 15 and 60 years. American Society of Anesthesiologists (ASA) Physical Status I. Clinical diagnosis of symptomatic irreversible pulpitis in a mandibular molar requiring primary root canal treatment.
  • Positive response to both the cold test and electric pulp test before treatment.
  • Presence of pulpal bleeding upon access cavity preparation, confirming pulp vitality.
  • Periodontal probing depth ≤3 mm. Sufficient coronal tooth structure to allow rubber dam isolation. No use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours before enrollment.
  • No known allergy or hypersensitivity to articaine or epinephrine. No history of systemic or genetic disease. Ability and willingness to provide written informed consent.

排除标准

  • Previous endodontic treatment of the study tooth. Extensive coronal destruction preventing rubber dam isolation. Internal or external root resorption. Periodontal probing depth >3 mm. Pregnancy or breastfeeding. Known allergy or hypersensitivity to articaine or epinephrine. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours before enrollment.
  • Presence of any systemic or genetic disease. Inability or unwillingness to provide written informed consent.

研究组 & 干预措施

Standard Inferior Alveolar Nerve Block

Experimental

干预措施: Inferior Alveolar Nerve Block with 4% Articaine (Procedure)

结局指标

主要结局

Success of Inferior Alveolar Nerve Block Anesthesia

时间窗: During root canal treatment.

Anesthetic success was defined as an HP-VAS score of less than 54 mm during access cavity preparation and root canal treatment in patients with symptomatic irreversible pulpitis. An HP-VAS score of 54 mm or greater was considered anesthetic failure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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