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

NCT ID: NCT06023524

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2023-10-31

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.

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.

Conditions

Laser Acupuncture; Impacted Third Molar Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Laser Acupuncture and Standard Medication

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Sham Laser Acupuncture and Standard Medication

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Antonius Hapindra Kasim

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KEPK FKUI RSCM

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

23-06-0952

Identifier Type: -

Identifier Source: org_study_id