临床试验/NCT06980363

NCT06980363尚未招募1 期

Efficacy of Articaine Plus Hyaluronidase Enzymes Infiltration Versus Traditional Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars

Fayoum University0 个研究点目标入组 20 人开始时间: 2025年6月1日最近更新: 2025年5月20日

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Fayoum University
入组人数: 20
主要终点: visual analogue scale (VAS)0_10

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

For both groups, local anaesthesia will be administered by one single surgeon and the extraction will be performed by another single surgeon across all subjects. The surgeon performing the extraction will be blinded with regard to the local anaesthesia technique used in this study
A buccal infiltration injection of 1.5 ml of 4% articaine with 1:100,000 adrenaline (Septocaine, Septodont, New Castle, Del.) plus 1.5 ml of hyaluronidase enzyme (7.5IU/1ml) will be used in the study group while use 4% articaine with 1:100,000 adrenaline (Septocaine, Septodont, New Castle, Del.)only in traditional inferior alveolar nerve block in the control group
In study and control groups, VAS (visual analogue scale=is an unmarked, continuous, horizontal,100-mm line, anchored by the end points of "no pain" on the left and "worst pain" on the right ) will be used to evaluate the pain levels of the patients associated with the injection and during extraction

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

•Medically stable patients
•Seeking for non surgical extraction of mandibular molar tooth

排除标准

•history of metabolic or systemic diseases affecting bone or healing process,
•local infection
•Grade III mobility
•Neurological disorder
•an analgesic use within 24 hours before anaesthesia administration

研究组 & 干预措施

traditional inferior alveolar nerve block by articaine

Active Comparator

干预措施: traditional inferior alveolar nerve block by articaine (Drug)

hyaluronidase plus articain buccal infiltration

Experimental

干预措施: hyaluronidase plus articain buccal infilteration (Drug)

结局指标

主要结局

visual analogue scale (VAS)0_10

时间窗: Periprocedural

Ask the patient to scoring his pain during the extraction by visualanalogue scale0_10 as 0 no pain and 10 sever pain

次要结局

未报告次要终点

研究者

发起方

Fayoum University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Shaimaa Mohsen

associate professor

Fayoum University

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