Comparative analysis of pain perception during administration of local anesthesia using a novel device
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- effect of pain perception using BioVibe-DentaPatch (BVDP) - a novel device during administration of local anesthesia.
研究概览
简要总结
**Introduction:**Dental anxiety and fear of needles hinder timely treatment, with intraoral injections being a major source of pain and discomfort. Pain perception varies based on factors like injection site and patient sensitivity among kids and adults.Traditional pain management methods include topical anesthetics and slow injection techniques, while non-pharmacological strategies like vibratory stimulation offer promising alternatives.Vibratory devices such as DentalVibe and VibraJect reduce injection pain via the Gate Control Theory. However, no bioadhesive vibrating patch exists yet. The study aims to evaluate BioVibe-DentaPatch (BVDP), a novel vibratory patch, in reducing injection pain in adults using the Visual Analogue Scale (VAS).
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Objectives:
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To evaluate the effect of pain perception using BioVibe-DentaPatch (BVDP) - a novel device during administration of local anesthesia.
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To compare the pain perception during administration of local anesthesia with and without BioVibe-DentaPatch (BVDP) - a novel device in patients undergoing dental procedures.
3.To evaluate and compare the pain perception using coolant and BioVibe-DentaPatch (BVDP)- a novel device during administration of local anesthesia in patients undergoing dental procedures.
Materials and methodology:
1.Endo Ice sticks
2.2% lignocaine with 1: 100,000 epinephrine (ICPA Xicaine, India)
- 21-mm aspirating type syringe, 27-gauge needle (Dispovan)
4.BioVibe- DentaPatch (BVDP)
A sample size of 100 patients will be chosen as per inclusion criteria. The subjects will be from the Department of Conservative Dentistry and Endodontics, Faculty of Dental Scienes, SGT Dental College, Gurugram. They are then divided into 2 groups- 50 patients per group.
Group A- local anesthesia administration without BVDP
Group B- local anesthesia administration with BVDP
Subgroup b1: local anesthesia administration with BVDP but without cryotherapy (ie., without use of coolant) n=25
Subgroup b2: local anesthesia administration with BVDP and cryotherapy (ie., use of coolant) n=25
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient aged 18 years and above
- •Patients who require local anesthetic injections prior dental procedure
- •Patients who are willing to participate.
排除标准
- •Subjects with systemic medical conditions
- •Patients with problems in comprehension
- •Patients allergic to local anesthetic agents.
结局指标
主要结局
effect of pain perception using BioVibe-DentaPatch (BVDP) - a novel device during administration of local anesthesia.
时间窗: degree of pain during the local anesthetic injections using Visual Analog Scale (VAS) will be recorded within five minutes of application. outcome will be assessed at baseline.
次要结局
- compare the pain perception during administration of local anesthesia with and without BioVibe-DentaPatch (BVDP) - a novel device in patients undergoing dental procedures(degree of pain during the local anesthetic injections using Visual Analog Scale (VAS) will be recorded within five minutes of application)
- pain perception using coolant & BioVibe-DentaPatch (BVDP)- a novel device during administration of local anesthesia in patients undergoing dental procedures.(degree of pain during the local anesthetic injections using Visual Analog Scale (VAS) will be recorded within five minutes of application. outcome will be assessed at baseline)
研究者
Dr Aishley Jain
Shree Guru Gobind Singh Tricentenary University