Clinical trial NCT06023524: The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Acupuncture
Impacted Third Molar Tooth
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
measure: Interincisal Space
timeFrame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
measure: Swelling
timeFrame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Special dental and oral hospital, Faculty of Dentistry, University of Indonesia
state: DKI Jakarta
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia
name: KEPK FKUI RSCM
role: PRINCIPAL_INVESTIGATOR
References: