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

NCT06023524 | Completed

• 1 other identifier: 23-06-0952
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Laser Acupuncture; Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (2)

Laser Acupuncture and Standard Medication

EXPERIMENTAL

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

Sham Laser Acupuncture and Standard Medication

SHAM COMPARATOR

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

Interventions

Laser Acupuncture and Standard Medication DEVICE

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

Laser Acupuncture and Standard Medication

Sham Laser Acupuncture and Standard Medication DEVICE

Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated

Sham Laser Acupuncture and Standard Medication

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• KEPK FKUI RSCM

  The Ethics Committee of the Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 5, 2023
• Study Start: September 4, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

ID (1)