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临床试验/NCT02975765
NCT02975765已完成不适用

Evaluation of the Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower Anterior Teeth: a Randomized Controlled Trial

Damascus University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Levels of Pain and Discomfort at 28 days

研究概览

简要总结

Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The levels of pain and discomfort of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy.

详细描述

According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time.

Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence on their acceptance and compatibility is little in the literature.

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adult healthy patients , Male and female, Age range: 16-26 years.
  • Severe crowding ≤ 7 (Little's irregularity index)
  • Permanent occlusion.
  • Exist all the Mandibular teeth (except third molars).
  • Good oral and periodontal health:
  • Probing depth<4 mm
  • No radiographic evidence of bone loss .
  • Gingival index≤ 1
  • Plaque index ≤ 1

排除标准

  • Medical problems that affect tooth movement (corticosteroid, NSAIDs, ...)
  • Patients have anti indication for oral surgery ( medical - social - psycho)
  • Presence of primary teeth in the mandibular arch
  • Missing permanent mandibular teeth (except third molars).
  • Poor oral hygiene or Current periodontal disease:
  • Probing depth ≥ 4 mm
  • radiographic evidence of bone loss
  • Gingival index > 1
  • Plaque index > 1
  • Patient had previous orthodontic treatment

研究组 & 干预措施

Traditional method

No Intervention

No intervention is going to be applied to the patients in this group.

Piezosurgery

Experimental

Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment

干预措施: Piezosurgery (Procedure)

结局指标

主要结局

Levels of Pain and Discomfort at 28 days

时间窗: at 28 days following the onset of orthodontic treatment

Pain and discomfort will be measured on visual analog scale

Levels of Pain and Discomfort at 14 days

时间窗: at 14 days following the onset of orthodontic treatment

Pain and discomfort will be measured on visual analog scale

Levels of Pain and Discomfort at one day

时间窗: at 24 hours following the engagement of first initial arch wire in the brackets

Pain and discomfort will be measured on visual analog scale

Levels of Pain and Discomfort at seven days

时间窗: at seven days following the onset of orthodontic treatment

Pain and discomfort will be measured on visual analog scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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