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临床试验/NCT04236115
NCT04236115已完成4 期

Does Articaine, Rather Than Prilocaine, Increase the Success Rate of Anaesthesia for Extraction of Maxillary Teeth

Taibah University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2017年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
95
试验地点
1
主要终点
Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth

研究概览

简要总结

Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines. Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Onset time of anaesthesia was objectively evaluated by using electronic pulp testing.

详细描述

85 patients in this study had successful local anaesthetic followed by extraction within the study duration time (10 minutes). However, there were six patients with failure anaesthesia (5 in prilocaine group and 1 in articaine group). By application Person's Chi-square test (x2), there were no significant differences in the number of the episodes of the anaesthetic success between articaine and prilocaine groups at time intervals (P-value = 0.5). T- test showed there have been no important variations within the mean onset time of anaesthesia for articaine and prilocaine buccal infiltrations (P-value =0.1).

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
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients have one or two upper teeth for extraction, subject tooth or its adjacent must be vital, healthy patient or patient with mild systemic diseases (class I or II according to American Society of Anesthesiology).

排除标准

  • Patients excluded from this study if they have allergy to local anaesthetic agents or need surgical, or multiple teeth extraction.

研究组 & 干预措施

Articaine 4% with 1:00.000 Adrenaline

Active Comparator

if the patient was in articaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction.

干预措施: Articaine 4% (Drug)

Articaine 4% with 1:00.000 Adrenaline

Active Comparator

if the patient was in articaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction.

干预措施: Adrenalin (Drug)

Prilocaine with 3% Felypressin (0.03 I.U. per ml)

Active Comparator

if the patient was in prelocaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction.

干预措施: Prilocain 3% (Drug)

Prilocaine with 3% Felypressin (0.03 I.U. per ml)

Active Comparator

if the patient was in prelocaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction.

干预措施: Felypressin (Drug)

结局指标

主要结局

Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth

时间窗: 6 months

to compare the anaesthetic performances of 3% prilocaine (the safest local anaesthetic) with 4 % articaine (the local anaesthetic with fastest onset time of action) when used for maxillary teeth extraction

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

Giath Gazal

Associate Professor

Taibah University

研究点 (1)

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