A Split Mouth, Randomised Controlled Trial to Compare the Efficacy of an Array of 2x3 Pyramidal Microneedles of 280µm Height Versus a Standard 30-gauge Dental Needle in the Delivery of Local Anaesthetic Solution for Dental Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pain Evaluation
研究概览
简要总结
The study will be completed as a two part, prospective, single-centre, randomised controlled trial.
Five volunteers (dentists) will be recruited in the first part of the study to evaluate and examine the microneedle device and its use. Based on those qualitative findings (individual interviews and focus group) modifications to the microneedle device will be implemented before part two of the study commences.
Twenty volunteers will be enrolled in the second part of the study. A split mouth design will be used to compare the efficacy of an array of 2x3 pyramidal wet-etch silicone microneedles of 280µm height with a standard 30-gauge short hypodermic needle in the delivery of local dental anaesthetic solution. Quantitative and qualitative measurements of the pain experienced and the depth of anaesthesia achieved will be recorded and compared.
详细描述
The study will be completed as a two part, prospective, single-centre, randomised controlled trial.
Five volunteers (dentists) will be recruited in the first part of the study in order to evaluate and examine the microneedle device and its use. Based on those qualitative findings (individual interviews and focus group) modifications to the microneedle device will be implemented before part two of the study commences.
Twenty healthy male volunteers will be invited to participate in the second part of the study. Participants will be randomly assigned to receive a dental anaesthetic solution injection with a microneedle device (Group I) or with a standard thirty-gauge short hypodermic needles (Group II) in the first week of the second part of the study.
Group I: The microneedle device will be applied randomly to the left or right buccal mucosa of the first premolar tooth in the maxilla in order to inject slowly a standard local dental anaesthetic solution.
Group II: A standard thirty-gauge short hypodermic needles will be used for insertion and injection of the same standard local dental anaesthetic solution randomly to the left or right buccal mucosa of the first premolar tooth in the maxilla.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Individuals are considered eligible for the study if they are not taking any medications and are deemed competent to complete the McGill pain questionnaire short-form (MPQ-SF) and visual analogue scale (VAS).
排除标准
- •Individuals will be excluded from the study if they suffer from the following conditions:
- •Hypersensitivity to anaesthetics of the amide type
- •Hypertension, impaired cardiac conduction
- •Impaired respiratory function
- •Impaired hepatic function
- •Cerebrovascular insufficiency
- •Thyrotoxicosis
- •Interventions not permitted during the study include the use of steroids, analgesics or other non-steroidal inflammatory drugs and smoking.
结局指标
主要结局
Pain Evaluation
时间窗: Immediately after injection of the anaesthetic
Discomfort / pain intensity rating will be recorded by using a visual analogue scale (VAS)
次要结局
- Pin-Prick Test(2 minute intervals alternating with fine touch test until onset of soft tissue anaesthesia)
- Pain Experience(Immediately after injection of the anaesthetic)
- Electronic Pulp Test(15 minutes after injection)
- Thermal Pulp Test(10 minutes after injection)
- Fine Touch Test(2 minute intervals alternating with pin-prick test until onset of soft tissue anaesthesia)
研究者
Darius Sagheri
Director of Orthodontic Therapy
University of Dublin, Trinity College