The Effectiveness Combination of Laser Acupuncture and Standard Medication on Pain Score, Interincisal Distance and Swelling in Mandibular Third Molar Post-Odontectomy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Visual Analog Scale
时间窗: 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.
Swelling
时间窗: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Assess the swelling dimensions using a tape measure
Interincisal Space
时间窗: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Assess the maximum distance of opening the mouth (interincisal space) using calipers
次要结局
未报告次要终点
研究者
Antonius Hapindra Kasim
doctor
Indonesia University