Does Ultrasonic Bone Scalpel Improve Surgical Outcomes in SSRO?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cutting Time
研究概览
简要总结
The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO.
详细描述
The purpose of this study was to answers following clinical questions:
- Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO. Hypotheses of this study that ultrasonic bone scalpel can improve BSSO and its postoperative results due to strong cutting efficiency and soft tissue protective effect.
Surgical procedure; After removing the full thickness mucoperiosteal flap lingula was localized. In ultrasonic device group, osteotomies one side of the mandible were performed unilaterally using an ultrasonic bone scalpel (BoneScalpel; Misonix, Farmingdale, NY) with a serrated standard blade. In conventional group, contralateral side mandibular osteotomies were performed with Lindeman and round bur. Groups are selected randomly.
c- Follow up
The predictor variable was the type of instrument used for bone osteotomy. The instruments were ultrasonic bone scalpel and Lindeman bur. The main outcome variable are the cutting time and NSD. All patients were followed for 6 months.The authors used the 3dMD imaging system (3dMD, Atlanta, GA) and 3dMD Vultus software to evaluate the amount of postoperative edema.
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
- 是
入选标准
- •Patients are included with older than 18 years old,
- •normal hemoglobin level, international normalized ratio in the average range,
- •American Society of Anesthesiologists status of ASA I and II.
排除标准
- •The exclusion criteria are neuropathic disease,
- •recent use of nonsteroidal anti-inflammatory drugs and opioid derivatives,
- •having preoperative signs of inflammation in the maxillofacial region,
- •presence of excessive bleeding in the previous surgery,
- •and allergy to drugs. All patients have given written informed consent.
研究组 & 干预措施
Lindeman
BSSO were performed with Lindeman and round bur
干预措施: Conventional (Device)
Bone scalpel
BSSO were performed unilaterally using an ultrasonic bone scalpel
干预措施: Bone Scalpel (Device)
结局指标
主要结局
Cutting Time
时间窗: during procedure
Length of cutting time was considered the time from the beginning the sagittal osteotomy to the end of making the vertical osteotomy line. The right and left side recorded separately.
neurosensory disturbance
时间窗: up to six months
Neuro sensory disturbance between the mental foramen and lower lip region on each side was evaluated subjectively after the operation day to a week. The examiner was blinded, and do not know which side of the mandible was randomly allocated to the experimental treatment.that was recorded by visual analog scale( VAS)
次要结局
- The splitting time(during procedure)
- postoperative edema(up to six months)
- The length of the procedure(during procedure)
- The pattern of the split(during procedure)
研究者
Selin Celebi
Resident
TC Erciyes University