跳至主要内容
临床试验/NCT04812639
NCT04812639Unknown不适用

Buccal Infiltration Technique in Comparison to the Inferior Alveolar Nerve Block Technique for Anesthetizing Mandibular Primary Molars During Pulpal Treatment

Cairo University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
试验地点
1
主要终点
Pain during pulpal treatment

研究概览

简要总结

This study was conducted to compare the efficacy of the buccal infiltration technique with inferior alveolar nerve block technique for alleviation of intraoperative pain during pulpal treatment of second mandibular primary molars using 4% Articaine 1:100000.

The study started with 22 cooperative medically free patients aging 7 to 8 years old seeking treatment for bilateral deep carious mandibular second primary molars with no previous history of irreversible pulpitis, swelling, sinus tract or tooth mobility.

Randomization was achieved when each candidate was instructed to pick an opaque and sealed envelope from two separate black and opaque boxes. First box contained two envelopes to identify the side on which the operator will perform the treatment. While the second box contained another two envelopes describing which anesthetic technique will be implemented with the previously chosen side.

After clinical and radiographic examination, the patient received the pulpal treatment under the identified side and injecting technique. Videotaping of the pulpal treatment procedure was initiated after numbness was experienced by the child.

A blind assessor was assigned to review the videos and fill in the SEM pain scale to identify the pain and level of discomfort experienced by the child during the pulpal treatment.

详细描述

This study was a split mouth randomized controlled trial enrolling 22 patients from the diagnostic center in the Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Cairo University. All participants met the following inclusion criteria:

  1. Cooperative children (rating four or three based on Frankl behavior scale) aging from seven to eight years.
  2. Medically free child categorized as ASA I or ASA II according to the American Society of anesthesiologist.
  3. Restorable bilateral deep carious lower primary second molars as shown in figure (1).
  4. Normal radiographic findings.

Preoperative periapical x-rays were done on the targeted molars to confirm their adherence to the eligibility criteria and to confirm their restorability.

Each participant was asked to pick an opaque and sealed envelope from two separate black and opaque boxes to randomly choose the operated technique and side on the first operating visit. By default the other technique will be implemented on the other side on the upcoming visit.

Proper psychological management and desensitization procedures were undertaken to prepare the patient for the treatment. Certain phrases were used to prepare the child for applying topical anesthetic gel and injecting the anesthetic agent in any given technique like "The magic water will be used to put the tooth to sleep".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

not showing the anesthetic procedure in the video tape

入排标准

年龄范围
7 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 7 to
  • •Medically free child ASA I or ASA II according to the American Society of anesthesiologist.
  • •Restorable bilateral deep carious lower primary second molars.
  • •Normal radiographic findings.

排除标准

  • •1- Uncooperative child (rating 1 or 2 on the Frankl behavior scale). 2- Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess.
  • •3- Radiographic signs of abscess, bone loss, internal or external root resorption was evident.
  • •4- Parents or guardians refused participating in the study.

研究组 & 干预措施

buccal infiltartion technique

Experimental

local anesthetic technique

干预措施: Inferior alveolar nerve block technique (Other)

Inferior alveolar nerve block technique

Active Comparator

local anesthetic technique

干预措施: Buccal infiltration technique (Other)

结局指标

主要结局

Pain during pulpal treatment

时间窗: up to one month

Sound Eye Motor SEM Pain scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Sherif Ahmed Abo El Abbas

Assistant Lecturer

Cairo University

研究点 (1)

Loading locations...

相似试验