Neuromodulation as an Adjunct to Local Anaesthesia in Paediatric Patients with MIH- A Pilot Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- -Reduction in Pain/Hypersensitivity
研究概览
简要总结
Summary
In pediatric dentistry, pain and anxiety due to injections or local anesthetics play a significant role in the development of negative behaviors and pose challenges in the management and treatment of young patients. This issue is further complicated by developmental defects like Molar Incisor Hypomineralization (MIH), which makes achieving effective anesthesia particularly difficult due to high tooth hypersensitivity. These challenges necessitate continuous research into alternative anesthesia and pain management modalities for MIH.
Transcutaneous Electrical Nerve Stimulation (TENS) or neuromodulation has shown promise in providing dental anesthesia or serving as an adjunct to local anesthesia. However, conventional devices using electric pads can exacerbate anxiety. Neuromodulation, based on the gate control theory and neuropeptide release, offers a potential solution. It can enhance or replace local anesthesia, reducing the need for repeated anesthetic injections and minimizing needle prick anxiety by either decreasing the sensation of the prick or eliminating the need for needle anesthesia altogether. This approach aims to deliver a more comfortable and pain-free dental experience for children with MIH.
hence a pilot study is taken up to evaluate and extend the basis for further research in this field.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA I or II Children aged 6-12 years.
- •Diagnosed with Molar Incisor Hypomineralization (MIH).
- •Requiring dental treatment under local anesthesia in either permanent molars or incisors.
排除标准
- •Known neurological disorders.
- •Allergies to local anesthetics.
- •Contraindications to neuromodulation.
结局指标
主要结局
-Reduction in Pain/Hypersensitivity
时间窗: At baseline | at start of treatment | at end of treatment | duration of anesthesia will be measured after 30 minutes from intervention | after 60 minutes form intervention
-Onset and Achievement of Anesthesia
时间窗: At baseline | at start of treatment | at end of treatment | duration of anesthesia will be measured after 30 minutes from intervention | after 60 minutes form intervention
-Patient Acceptance
时间窗: At baseline | at start of treatment | at end of treatment | duration of anesthesia will be measured after 30 minutes from intervention | after 60 minutes form intervention
-Duration of Anesthesia
时间窗: At baseline | at start of treatment | at end of treatment | duration of anesthesia will be measured after 30 minutes from intervention | after 60 minutes form intervention
次要结局
- -Patient Acceptance(-Duration of Anesthesia)
研究者
Dr Bhawna Saxena
I.T.S Dental College Hospital and Research Centre
