Viewing Study NCT04804761



Ignite Creation Date: 2024-05-06 @ 3:55 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04804761
Status: RECRUITING
Last Update Posted: 2023-03-01
First Post: 2021-03-16

Brief Title: The Effect of Electroacupuncture EA on the Success of Inferior Alveolar Nerve Block IANB and Post-operative Pain Relief in Mandibular Molar With Symptomatic Irreversible Pulpitis SIP Among Malaysians A Study Protocol for Randomized Double-Blinded Clinical Pilot Study
Sponsor: International Medical University
Organization: International Medical University

Study Overview

Official Title: The Effect of Electroacupuncture EA on the Success of Inferior Alveolar Nerve Block IANB and Post-operative Pain Relief in Mandibular Molar With Symptomatic Irreversible Pulpitis SIP Among Malaysians A Study Protocol for Randomized Double-Blinded Clinical Pilot Study
Status: RECRUITING
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Acupuncture is recognized for its pain relief effect ElectroacupunctureEA is a form of acupuncture where electric current is passed between pairs of acupuncture needles in order to achieve therapeutic effect However there are significantly low number of studies which have discussed the effect of electroacupuncture on dental treatment Symptomatic irreversible pulpitis is a common condition among dental patients The success rate of inferior alveolar nerve block before commencing the endodontic treatment of a tooth diagnosed with SIP is reported to be relatively as low as 25 The aim of this study is to determine the effect of electroacupuncture on the success rate of inferior alveolar nerve block and post-operative pain relief for symptomatic irreversible pulpitis among Malaysians
Detailed Description: A randomized double-blinded clinical pilot study will be conducted in an IMU Oral Health Centre registered under Malaysia local authority Convenient stratified blocked random sampling method will be used Subjects included are those who will undergo endodontic treatment due to SIP between April 2020 to April 2022 20 subjects are randomly allocated into real and sham acupuncture group Electroacupuncture on LI4 HeGu PC6 NeiGuan ST6 JiaChe and ST7 XiaGuan will be applied on patients for 30 minutes before endodontic treatment Pain levels are measured with Heft-Parker visual analog scale HP-VAS at the time point before and after EA before and after endodontic treatment 12 hours 24 hours and 48 hours after the treatment For sham acupuncture group blunted needles which do not penetrate the skin but will only be placed on the skin and stabilised by cotton ball and surgical tape at respective acupuncture points No manipulation will be conducted for the sham acupuncture group Patients endodontist and data analyst are blinded in this study Data collected will be analysed using Statistical Package for the Social Science SPSS version 250 Paired T-test will be used to compare the pre-EA and post-EA pain score T-test will be used to compare the pain scores of real and sham EA groups at each time interval including post-EA during treatment and post-treatment and for induction time of IANBs in real and sham EA groups

This study will identify the effect of EA on the success rate of IANB and post-operative pain relief for SIP among Malaysian

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None