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临床试验/NCT07296926
NCT07296926招募中不适用

Comparison of Efficacy of Distolingual Infiltration in Conjugation With Conventional Inferior Alveolar Nerve Block to Conventional Inferior Alveolar Nerve Block Alone for Extraction of Mandibular Third Molar

Watim Medical & Dental College1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Pain during mucoperiosteal flap elevation

研究概览

简要总结

This randomized controlled trial will compare the effectiveness of adding distolingual infiltration to conventional inferior alveolar and buccal nerve blocks for mandibular third molar extraction. A total of 120 patients will be allocated into two groups. Pain during flap elevation and bone guttering will be assessed using the Visual Analogue Scale.

详细描述

Mandibular third molar extraction is a common oral and maxillofacial surgery procedure that requires profound local anesthesia. Despite conventional inferior alveolar, lingual and buccal nerve blocks, the distolingual gingiva may remain non-anesthetized due to accessory innervation via the mylohyoid and other nerves. Distolingual infiltration may improve anesthesia in this area.

This randomized controlled trial will enroll 120 patients requiring mandibular third molar extraction. Participants will be randomized into two groups: conventional inferior alveolar and buccal nerve block (Group A) and the same technique with additional distolingual infiltration (Group B). Pain during mucoperiosteal flap elevation and bone guttering will be recorded on a 0-10 Visual Analogue Scale. The primary objective is to determine whether distolingual infiltration improves pain control compared to the conventional technique.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals
  • Male and female
  • Age 18-45 years
  • Mandibular third molar impaction - all positions
  • Mandibular third molar impaction - all classes

排除标准

  • ASA status III and above
  • Patients requiring multiple extractions in the same appointment
  • Allergy to lignocaine
  • Patients in whom adrenaline is contraindicated
  • Medically compromised individuals e.g. poorly controlled diabetes, hypertension

研究组 & 干预措施

conventional nerve block injection

Active Comparator

Inferior alveolar and buccal nerve block using 2% lignocaine with adrenaline (1:80,000) without distolingual infiltration.

干预措施: Conventional Inferior Alveolar and Buccal Nerve Block (Procedure)

conventional inferior alveolar with distolingual infilterate injection

Experimental

Inferior alveolar supplemented with distolingual infiltration using 2% lignocaine with adrenaline (1:80,000).

干预措施: Distolingual Infiltration plus Conventional Nerve Block (Procedure)

结局指标

主要结局

Pain during mucoperiosteal flap elevation

时间窗: During mucoperiosteal flap elevation on the day of surgery

Pain intensity experienced during flap elevation will be assessed using the Visual Analogue Scale (VAS). This is a 0-10 point numerical scale where participants indicate the pain level experienced at the time of flap elevation. Measurement Tool: Visual Analogue Scale (VAS) Scale: * Minimum score: 0 (no pain) * Maximum score: 10 (worst possible pain) * Directionality: Higher scores indicate worse pain

Pain During Bone Guttering

时间窗: During bone guttering on the day of surgery.

Pain intensity during bone guttering will be recorded using the Visual Analogue Scale (VAS). Measurement Tool: Visual Analogue Scale (VAS) Scale: * Minimum: 0 (no pain) * Maximum: 10 (worst pain) * Higher scores = worse pain

次要结局

未报告次要终点

研究者

发起方
Watim Medical & Dental College
申办方类型
Other
责任方
Principal Investigator
主要研究者

aimen zafar

prinicpal investigator

Watim Medical & Dental College

研究点 (1)

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