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临床试验/NCT05839093
NCT05839093已完成不适用

Evaluation of the Efficiency of Intraligamentary + Buccal Infiltration Anesthesia and Inferior Alveolar Nerve Block + Buccal Infiltration Anesthesia in Symptomatic Mandibular Molars With Irreversible Pulpitis

Cukurova University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年12月21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
210
试验地点
1
主要终点
The success of anesthesia techniques

研究概览

简要总结

The aim of this clinical study is to evaluate the success of buccal infiltration (BI) anesthesia + intraligamentary (ILI) anesthesia between inferior alveolar nerve block (IANB) anesthesia + buccal infiltration anesthesia in mandibular molar teeth with acute symptomatic irreversible pulpitis.The main questions it aims to answer are:

  • Does the anesthesia techniques adequate to perform root canal treatment painlessly?
  • Which technique achieved pulpal anesthesia? Participants were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. Then, root canal treatment was performed.

Researchers were compared the success of anesthesia techniques in different stages of root canal treatment.

详细描述

A total of 50 patients, aged between 18-65, who were diagnosed with symptomatic irreversible pulpitis of the mandibular molar tooth, were included in this study. The patients were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. After the anesthesia, a rubber dam was placed on the associated tooth of the patient for root canal treatment, the endodontic access cavity was opened, and canal preparation procedures were started. The pain levels felt by the patients during the endodontic treatment stages (starting the treatment, opening the endodontic access cavity and pulp extirpation) were determined by Heft-Parker VAS (HP-VAS) scale. Anesthesia was considered successful in patients who felt no pain (HP-VAS ratio = 0) or mild pain (HP-VAS ratio ≤ 54) during the procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

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
是

入选标准

  • •Systemically healthy patients
  • •The absence of periapical pathology
  • •Not sensitive to articaine or epinephrine
  • •No facial paresthesia
  • •Not taking any analgesic drug 6 hours before treatment
  • •Not taking any medication that interferes with anesthesia, such as tricyclic antidepressants and beta-blockers
  • •The absence of pathosis in areas planned for injection
  • •Not pregnant
  • •The absence of pathologic periodontal pockets during probing
  • •Patients with a mandibular first molar tooth exhibiting symptomatic irreversible pulpitis

排除标准

  • 未提供

研究组 & 干预措施

Inferior Alveolar Nerve Block Group

Active Comparator

A standard Inferior Alveolar Nerve Block (IANB) injection with a conventional dental injector and a 27-G needle to achieve pulpal anesthesia in mandibular molar teeth.

干预措施: Inferior Alveolar Nerve Block Group (Device)

Intraligamentary Injection Group

Experimental

An intraligamentary injection that performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle.

干预措施: Intraligamentary Injection Group (Device)

结局指标

主要结局

The success of anesthesia techniques

时间窗: 0-2 hours

Heft-Parker visual analog scale (HPVAS) was used to evaluate the patient's subjective pain and convert it to quantitative values. The pain was classified as follows: 0, no pain as "1"; 1-54 mm, mild pain as "2"; 55-112 mm, moderate pain as "3"; and 114-170 mm, severe pain as "4". If the VAS value is 1 and 2, anesthesia is considered successful, if 3 and 4, anesthesia is considered unsuccessful. HPVAS-1 determines the VAS value of pain response to cold test. The VAS value of the pain response at the start of the treatment is HPVAS-2. The VAS value of the pain response on entering the pulp chamber HPVAS-3: The VAS value of the pain response during pulp extirpation was recorded as HPVAS-4.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şehnaz Yilmaz, DDS, PhD

Associated Professor

Cukurova University

研究点 (1)

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