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

Impacted Third Molar Tooth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06023524
• Other study ID #: 23-06-0952
• Status: Completed
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

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 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

Locations

Country	Name	City	State
Indonesia	Special dental and oral hospital, Faculty of Dentistry, University of Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Interincisal Space	Assess the maximum distance of opening the mouth (interincisal space) using calipers	Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Primary	Swelling	Assess the swelling dimensions using a tape measure	Day-1 (baseline), Day-3 and Day-7 post-odontectomy