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

February 27, 2023 updated by: SIN YEN SUAN, International Medical University
Acupuncture is recognized for its pain relief effect. Electroacupuncture(EA) 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 25.0. 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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 57000
        • Recruiting
        • International Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Shivani Kohli
        • Sub-Investigator:
          • Kim Sia Sng
        • Sub-Investigator:
          • Wen Tien Tan
        • Sub-Investigator:
          • Goon Month Lim
        • Sub-Investigator:
          • Si Woei Goh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All Malaysians above the age of 18 years old having a restorable first or second mandibular molar with symptomatic irreversible pulpitis and a history of spontaneous pain presenting with pain level above 54 mm using 170 mm Heft-Parker visual analogue scale (HP-VAS).

Exclusion Criteria:

  • Patient with severe systemic disorders, mental disorders, seizures or epilepsy, heart disease, severe clotting disorders, severe periodontal disease or a widening of the periodontal ligament space or periapical radiolucency.
  • Patient having a pacemaker.
  • Pregnant or lactating women.
  • Patient who is true needle phobia [51].
  • Patient who has a malignant tumor, wound, infection, lymphedema or fracture at electroacupuncture site.
  • Patient who is sensitive to mepivacaine and paracetamol.
  • Patient who has a history of treatment with acupuncture, or using any type of medication that could affect the current perception of pain such as tricyclic antidepressants, selective serotonin reuptake inhibitors, analgesics, corticosteroids, or antibiotic at least 24 hours before the endodontic therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real EA group
Other: Electroacupuncture
Needle insertion on bilateral LI4 HeGu and PC6 NeiGuan and ipsilateral ST6 JiaChe and ST7 XiaGuan (as shown in Table 1), using disposable sterile acupuncture needles (length 25 mm, diameter 0.25 mm; Seirin Corporation, Shizuoka, Japan)
Sham Comparator: Sham EA group
Other: Electroacupuncture
Needle insertion on bilateral LI4 HeGu and PC6 NeiGuan and ipsilateral ST6 JiaChe and ST7 XiaGuan (as shown in Table 1), using disposable sterile acupuncture needles (length 25 mm, diameter 0.25 mm; Seirin Corporation, Shizuoka, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain levels on HP-VAS after electroacupuncture
Time Frame: Immediately after needle removal
Immediately after needle removal
HP-VAS during endodontic procedure
Time Frame: During endodontic procedure
During endodontic procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
HP-VAS at 12 hours, 24 hours and 48 hours after the treatment
Time Frame: 12 hours, 24 hours and 48 hours after the treatment
12 hours, 24 hours and 48 hours after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Medical University

Investigators

  • Principal Investigator: Yen Suan Sin, International Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCM I/2019(05)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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