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临床试验/CTRI/2024/05/068068
CTRI/2024/05/068068已完成Phase 3 4

Neuromodulation as an Adjunct to Local Anaesthesia in Paediatric Patients with MIH- A Pilot Study

ITS Dental college hospital and research centre1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年6月10日最近更新:

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

发起方
ITS Dental college hospital and research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bhawna Saxena

I.T.S Dental College Hospital and Research Centre

研究点 (1)

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