跳至主要内容
临床试验/CTRI/2025/03/082013
CTRI/2025/03/082013尚未招募Unknown

Efficacy of Buffered Articaine in Maxillary Third Molar Extractions

Bandi Sandeep Paul1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年3月24日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Pain at Injection Site, Onset of Anesthesia, Duration of Anesthesia, Post Extraction Pain

研究概览

简要总结

A randomized double blind split mouth interventional study will be conducted with an aim to examine whether buffering articaine will help in terms of pain at injection site, onset of anesthesia, duration of anesthesia, post extraction pain. the objectives of the study were to assess the pain, onset of anesthesia,  duration of anesthesia, and post extraction pain at the injection site of Articaine and Buffered Articaine groups. and to compare pain at the site of injection, onset of anesthesia, duration of anesthesia, and post extraction pain between Articaine and Buffered Articaine groups. A total of 52 patients reporting to the department of oral and maxillofacial surgery during the study period for maxillary third molar extractions will be selected based on inclusion and exclusion criteria Study will be explained and written informed consent will be obtained from the participants and patients will be randomly assigned to one of the two groups (Group-1 Articaine, Group-2 Buffered Articaine) by coin toss method. In Group 1 Articaine will be administered by buccal infiltration (0.9ml) alone and extraction was done and in Group 2 Buffered Articaine will be administered by buccal infiltration (0.9ml) and extraction was done and pain at injection and onset of anesthesia will be assessed immediately after injection and surgical procedure will be carried out by single surgeon later duration of anesthesia, post extraction pain will be assessed post operatively after 3 hours. Statistical analysis will be done using descriptive and inferential statistics that include Dependent t test / Wilcoxon signed rank test to compare variables between both the groups.

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA-I and ASA-II (American society of anaesthesiologists).
  • 2.Patients with age group of 18-60 years.
  • 3.Patients with acute inflammatory conditions requiring extractions of maxillary third molars.
  • 4.Pell and Gregory class I.

排除标准

  • 1.Presence of conditions that prevent dental extractions, like uncontrolled bleeding disorders.
  • 2.Necessity of surgical access and bone removal (osteotomy) for maxillary molar surgery.
  • 3.A record of allergies or negative reactions to articaine or similar local anaesthetics.
  • 4.Pregnant and lactating women.

结局指标

主要结局

Pain at Injection Site, Onset of Anesthesia, Duration of Anesthesia, Post Extraction Pain

时间窗: Pain at Injection Site, Onset of Anesthesia, will be assessed immediately and Duration of Anesthesia, Post Extraction Pain after 3 hours

次要结局

  • any adverse reactions(immediately and after extraction)

研究者

发起方
Bandi Sandeep Paul
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bandi Sandeep Paul

SIBAR Institute of Dental Sciences

研究点 (1)

Loading locations...

相似试验