跳至主要内容
临床试验/CTRI/2025/04/083885
CTRI/2025/04/083885已完成不适用

Anesthetic Efficacy of Hyaluronidase as an Adjuvant to Lignocaine-Epinephrine in Maxillary Anterior Extractions: A Randomized Controlled Trial

DR ROSHANI R AUTADE1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年4月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
pain, local anesthetic effect, time of onset of anesthesia, complications

研究概览

简要总结

Maxillary anterior tooth extractions are routinely performed procedures under local anesthesia and account for 13.9% of total extractions. The efficacy of local anesthesia is paramount to ensure patient comfort, reduce anxiety, and facilitate a smooth procedure. The infiltration technique is commonly used for anesthesia, with lignocaine (lidocaine) being the anesthetic agent of choice in combination with epinephrine to prolong the anesthetic effect and minimize bleeding. Hyaluronidase is an enzyme that hydrolyses the hyaluronic component of the intercellular ground substance, hence the viscosity of the tissues is reduced permitting a wider spread of the local anesthetic solution.

The porous bone in the anterior maxilla offers an ideal medium for the diffusion of local anesthesia from the buccal to the palatal side of the associated tooth. When used in conjunction with hyaluronidase, this formulation facilitates the adequate distribution of the anesthetic, thereby ensuring sufficient analgesia and obviating the necessity for a painful palatal infiltration.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • patients requiring prophylactic or remedial extraction of maxillary central and lateral incisors.

排除标准

  • Patient with co morbidities
  • History of immunosuppressant use within last 6 months
  • Past or ongoing chemotherapy or radiotherapy
  • Patients with altered hemodynamic values.
  • Women who are pregnant, lactating or taking oral contraceptives.
  • Allergy or hypersensitivity to any of the products used in the study.
  • Any pre operative infection or edema.

结局指标

主要结局

pain, local anesthetic effect, time of onset of anesthesia, complications

时间窗: immediately after administration of local anesthetic, 30,60,90,120sec and so on.

次要结局

  • Time of onset of anesthesia after administration of Local Anesthetic solution, Other complication(Localized / systemic)

研究者

发起方
DR ROSHANI R AUTADE
申办方类型
Other [Individual- Dr Roshani R. Autade (Principal Investigator)]
责任方
Principal Investigator
主要研究者

Dr. Roshani R. Autade

Government Dental College and Hospital, Jamnagar

研究点 (1)

Loading locations...

相似试验