跳至主要内容
临床试验/NCT06302907
NCT06302907Unknown不适用

The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration: A Crossover Clinical Trial.

Al-Wataniya University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2023年1月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Pain on injection

研究概览

简要总结

The aim of the present study was to evaluate the pain during local anesthetic buccal infiltration for the maxillary canines after adding Sodium Bicarbonate 8.4% during local anesthesia.

详细描述

Materials and Methods The present research was approved by the Institutional Review Board of the College of Dentistry at Al Wataniya Private University (M/45- 14.1.2023).

30 healthy patients were recruited, aged between 15-50 years, and divided into two groups (15 males and 15 females). Every patient had to meet the following conditions:

  • Caries free with no restorations, periapical lesions, or history of trauma at the site of injection.
  • Willingness to participate in the study and ability to describe and evaluate their pain.
  • No painkillers, or sedatives taken for at least 24 hours so that pain assessment isn't affected.
  • No allergy to local anesthetics.
  • No pregnancy. Each patient received buccal infiltration with the anesthetic solution alone at one upper canine site and local anesthetic with added sodium bicarbonate at the other site. The local anesthetic used was 2% Lidocaine with 1:80.000 Epinephrine produced by New-Stetic S.A.- Colombia. Whereas 8.4% Bicarbonate Sodium was produced by TCE - UK. Injections were performed using 25 mm short needles (Gauge 27) manufactured by C-K Dental - South Korea.

Consent for each patient was obtained before the clinical session. Local infiltration was performed using a one-third cartridge (0.6 mL) of the local anesthetic on one side and local anesthetic with added Sodium Bicarbonate on the counterpart side leaving 5 minutes between the injections.

Alkalinization of the local anesthetic was performed using the technique described by Saatchi et al13. 0.2 mL of the anesthetic solution was extracted using a tuberculin syringe and then discarded. 0.2 mL sodium bicarbonate was then loaded and added to the cartridge. Afterward, the solution was slowly shaken 20 times and ready to be administered with a cartridge syringe.

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
Single (Participant)

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Caries free with no restorations, periapical lesions, or history of trauma at the site of injection.
  • Willingness to participate in the study and ability to describe and evaluate their pain.
  • No painkillers, or sedatives taken for at least 24 hours so that pain assessment isn't affected.

排除标准

  • allergy to local anesthetics.
  • pregnancy

研究组 & 干预措施

Buffered LA

Active Comparator

AA buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site

干预措施: Buffered Local anaesthesia (Procedure)

Buffered LA

Active Comparator

AA buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site

干预措施: Unbuffered Local anaesthesia (Procedure)

Unbuffered LA

Active Comparator

an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.

干预措施: Buffered Local anaesthesia (Procedure)

Unbuffered LA

Active Comparator

an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.

干预措施: Unbuffered Local anaesthesia (Procedure)

结局指标

主要结局

Pain on injection

时间窗: one week

\- Pain was measured on a visual analogue scale (VAS) starting from 0 which represents (no pain at all) and ending with 10 which represents (the most severe pain)

次要结局

未报告次要终点

研究者

发起方
Al-Wataniya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tarek Khaled Abou Agwa

Senior lecturer

Al-Wataniya University

研究点 (2)

Loading locations...

相似试验