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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Laser Acupuncture, Impacted Third Molar Tooth

Intervention / Treatment
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* Device: Laser Acupuncture and Standard Medication
* Device: Sham Laser Acupuncture and Standard Medication


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Acupuncture and Standard Medication<br>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<br>* 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<br>|
| Sham Comparator: Sham Laser Acupuncture and Standard Medication<br>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<br>* Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |