Clinical trial NCT04804761: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis (SIP)
Lead sponsor: International Medical University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty subjects will be recruited from IMU Oral Health Centre, Bukit Jalil who come for endodontic treatment due to symptomatic irreversible pulpitis between April 2020 to April 2022.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain levels on HP-VAS after electroacupuncture
timeFrame: Immediately after needle removal
measure: HP-VAS during endodontic procedure
timeFrame: During endodontic procedure
Secondary outcomes:
measure: HP-VAS at 12 hours, 24 hours and 48 hours after the treatment
timeFrame: 12 hours, 24 hours and 48 hours after the treatment
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: International Medical University
Study officials:
affiliation: International Medical University
name: Yen Suan Sin
role: PRINCIPAL_INVESTIGATOR
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