临床试验/NCT05875519

NCT05875519已完成不适用

Evaluation of Healing Process and Blood Sugar Level Following Local Anesthetic Infiltration With and Without Vasoconstrictor for Extraction of Maxillary Teeth in Diabetic Patients Double Blind Randomized Clinical Trial

Minia University1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2023年5月20日最近更新: 2024年12月31日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 40
试验地点: 1
主要终点: Glycemic level recorded before local anesthesia administration and 30 minutes following local anesthesia injection using glucometer

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研究点记录与标识符相似试验

研究概览

简要总结

Evaluating the healing of the extraction socket and the glycemic levels before, and after injection of local anesthesia with and without vasoconstrictor in diabetic patients

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: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 20 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Inclusion criteria patients over 20 years and under 60 years of age
•DM controlled by medication
•Requiring a tooth extraction in the maxilla, with an indication of the intra-alveolar technique for periodontal reasons.
•Only participants that are willing to control and record blood glucose level throughout the study period.

排除标准

•Patients with any significant medical condition (besides DM)
•Alcoholic individuals
•Patients on drugs that affect the central nervous systems
•Patients who reported the use of drugs that might interfere with pain sensitivity
•Pregnant and lactating women
•Patients with hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).

研究组 & 干预措施

Anaesthesia with vasocontrictor

Experimental

干预措施: Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg) (Drug)

Anaesthesia without vasocontrictor

Active Comparator

干预措施: Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg) (Drug)

结局指标

主要结局

Glycemic level recorded before local anesthesia administration and 30 minutes following local anesthesia injection using glucometer

时间窗: 30 minutes

次要结局

Healing score of the extraction socket(21 days)

研究者

发起方

Minia University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Tarek Abdelbarry

Lecturer of Oral and Maxillofacial Surgery

Minia University

研究点 (1)

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