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临床试验/CTRI/2025/09/094809
CTRI/2025/09/094809尚未招募不适用

Buffered 2 percent Lignocaine Vs Buffered 4 percent articaine in Mandibular Flap Surgery A Double Blind Split Mouth Trial

Gangolu Meghana1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年9月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
1.Onset Time

研究概览

简要总结

This double-blind, split-mouth randomized controlled trial is designed to compare the clinical efficacy of buffered 2 percent lignocaine and buffered 4 percent articaine in patients undergoing bilateral mandibular periodontal flap surgery. To enhance onset and comfort. A total of 16 patients ie 32 surgical sites will be enrolled. Each patient will receive both anaesthetics on contralateral sides in two appointments. The buffered solutions are prepared with sodium bicarbonate Clinical outcomes assessed include onset time, duration of anaesthesia, intraoperative pain VAS, need for reinjection, and adverse effects. Randomization and blinding of operator and patient will minimize bias, and all surgeries will be performed by the same periodontist. Statistical analysis will involve paired t-tests for continuous variables and chi-square tests for categorical data, with significance set at p < 0.05. The study aims to determine whether buffered articaine provides superior onset, duration, and patient comfort compared to buffered lignocaine, thereby guiding clinicians in optimal anaesthetic choice for mandibular periodontal surgeries.

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
25.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients requiring bilateral mandibular periodontal surgery 2 Age between 30- 60 years.
  • 3 No allergy to local anesthetics or sodium bicarbonate.
  • 4 Willingness to provide informed consent.

排除标准

  • Pregnant or lactating women •Patients with systemic conditions affecting wound healing (e.g., diabetes) •History of hypersensitivity to local anesthetics or epinephrine •Active infection at the surgical site.

结局指标

主要结局

1.Onset Time

时间窗: 1.Time from injection to onset of numbness (in seconds) | 2.Time from onset to return of normal sensation (in how many seconds) | 3.45 minutes

2.Duration of Anesthesia

时间窗: 1.Time from injection to onset of numbness (in seconds) | 2.Time from onset to return of normal sensation (in how many seconds) | 3.45 minutes

3.VAS Pain Score

时间窗: 1.Time from injection to onset of numbness (in seconds) | 2.Time from onset to return of normal sensation (in how many seconds) | 3.45 minutes

次要结局

  • 1. Reinjection Needed(2 Any Adverse Effects)

研究者

发起方
Gangolu Meghana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gangolu Meghana

sibar institute of dental sciences

研究点 (1)

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