The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients

The Effectiveness Combination of Laser Acupuncture and Standard Medication on Pain Score, Interincisal Distance and Swelling in Mandibular Third Molar Post-Odontectomy Patients

Acute toothache is a problem that often occurs in the oral cavity. Toothache can be caused by an impacted tooth, in which the tooth cannot or will not erupt into its normal position. The American Association of Oral and Maxillofacial Surgeons (AAOMFS) states that 9 out of 10 people have at least one impacted tooth, and impacted mandibular third molars have the greatest prevalence. Laser acupuncture is an acupuncture modality that has the benefit of reducing pain after third molar extraction. The goal of this randomized controlled trial is to evaluate the group that received a combination of laser acupuncture and standard medication compared to the group that received the combination of sham laser acupuncture and standard medication alone, in management of post-mandibular odontectomy patients. The main objective of this study is to analyze the combination of laser acupuncture and medication significantly improving the patient's pain intensity, interincisal distance and post-odontectomy swelling compared to the combination group of sham laser acupuncture and medication.

Study Overview

• Status: Completed
• Conditions: Impacted Third Molar Tooth; Laser Acupuncture
• Intervention / Treatment: Device: Laser Acupuncture and Standard Medication; Device: Sham Laser Acupuncture and Standard Medication

Detailed Description

This is a clinical trial study to evaluate the group that received a combination of laser acupuncture and standard medication compared to the group that received the combination of sham laser acupuncture and standard medication alone, in management of post-mandibular odontectomy patients. The required sample was 57 mandibular third molars in male/female subjects post-odontectomy and randomized into 2 groups: (1) combination of laser acupuncture with standard medication and (2) combination of sham laser acupuncture with standard medication. The subjects will receive two times treatment, on day-1 (baseline) and day-3 after odontectomy. The outcome will be assessed on day-1 (baseline), day-3 and day-7 post-odontectomy. Patients and outcome assessors will be blinded to the group allocation.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonius H Kasim, Doctor; Phone Number: +6281296838259; Email: hapindra@gmail.com
• Study Contact Backup: Name: The Ethics Committee of the Faculty of Medicine University of Indonesia - Cipto Mangunkusumo Hospital; Phone Number: +6221315 7008; Email: ec_fkui@yahoo.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Special dental and oral hospital, Faculty of Dentistry, University of Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subject
• Age 18 - 40 years
• Classification of Pell and Gregory class I, II and positions A, B, C
• Willing to participate in this research and sign informed consent

Exclusion Criteria:

• Pregnancy
• Have a history of using corticosteroid drugs in the last 3 months
• Have a history of medication with analgesics at least 24 hours before surgery
• Have an unstable systemic disease (such as uncontrolled hypertension and diabetes etc.)
• The patient has a medical emergency / hemodynamically unstable (such as having a hypertensive crisis)
• Wounds or skin diseases at the location of the acupuncture point irradiation
• Patients with a history of epilepsy
• High fever (> 38oC).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Acupuncture and Standard Medication; Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points.	Device: Laser Acupuncture and Standard Medication; Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points
Sham Comparator: Sham Laser Acupuncture and Standard Medication; Sham Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated	Device: Sham Laser Acupuncture and Standard Medication; Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interincisal Space	Assess the maximum distance of opening the mouth (interincisal space) using calipers	Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Swelling	Assess the swelling dimensions using a tape measure	Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Visual Analog Scale	Rating scale for measuring pain, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.	Day-1 (baseline), Day-3 and Day-7 post-odontectomy

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KEPK FKUI RSCM, The Ethics Committee of the Faculty of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: August 27, 2023
• First Submitted That Met QC Criteria: August 27, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 23-06-0952

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No