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Completed

NCT Number: NCT06023524

The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular 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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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