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

• ClinicalTrials.gov Identifier: NCT06023524
• Recruitment Status: Completed
• First Posted: September 5, 2023
• Sponsor: Indonesia University
• Information provided by (Responsible Party): Antonius Hapindra Kasim, Indonesia University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Laser Acupuncture; Impacted Third Molar Tooth	Device: Laser Acupuncture and Standard Medication; Device: Sham Laser Acupuncture and Standard Medication	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness Combination of Laser Acupuncture and Standard Medication on Pain Score, Interincisal Distance and Swelling in Mandibular Third Molar Post-Odontectomy Patients
• Actual Study Start Date: September 4, 2023
• Actual Primary Completion Date: October 31, 2023
• Actual Study Completion Date: October 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Visual Analog Scale [ Time Frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy ]
   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.
2. Interincisal Space [ Time Frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy ]
   Assess the maximum distance of opening the mouth (interincisal space) using calipers
3. Swelling [ Time Frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy ]
   Assess the swelling dimensions using a tape measure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

Indonesia

Special dental and oral hospital, Faculty of Dentistry, University of Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia, 10430

Sponsors and Collaborators

Indonesia University

Investigators

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

More Information

• Responsible Party: Antonius Hapindra Kasim, doctor, Indonesia University
• ClinicalTrials.gov Identifier: NCT06023524
• Other Study ID Numbers: 23-06-0952
• First Posted: September 5, 2023
• Last Update Posted: November 8, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Tooth, Impacted; Tooth Diseases; Stomatognathic Diseases