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临床试验/NCT04940351
NCT04940351Unknown不适用

Comparative Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Amount of Crowding Relieved

研究概览

简要总结

In recent times, many patients want their treatment duration to be reduced, because lengthy orthodontic treatment duration is associated with negative sequelae such as discomfort, pain, white spot lesions, and decreased patient's compliance. Several techniques have been employed in an attempt to accelerate the tooth movement and shorten the lengthy orthodontic treatment duration. So, this study will investigate the effectiveness of minimal invasive technique like piezocision and microosteoperforation in alleviating mandibular anterior crowding which is one of the common malocclusiom and provide scientific knowledge regarding which minimal invasive tecnique will relieve the crowding faster.

详细描述

Records will be taken from patients who are meeting selection criteria and then analysis of record will be done to attain a proper diagnosis and treatment plan. Afterthat, those patients will be referred to oral surgery department for extraction of first premolar. After healing, orthodontic treatment will be started with bonding of preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, randomisation and allocation of two groups will be done and on the day of initial aligning archwire placement i.e., 0.014" NiTi, active interventions(piezocision and micro-osteoperforations) will be done for each group and then levelling and alignment will be continued with the following arch wire sequence 0.016" , 0.016" x 0.022" and 0.017" x 0.025" NiTi. Levelling and alignment will be considered finished when 0.017x0.025" NiTi archwire will be engaged passively in the brackets. Records i.e,. mandibular study models will be taken on the day of surgical procedure before surgery (T0) and then after every 4th week i.e., 4th week(T1), 8th week(T2), 12th week(T3), 16th week(T4). Following this, data collection and interpretation of results will be done. And also, CBCT will be taken at post levelling and alignment with 0.017" x 0.025" arch wire to assess the root resorption and marginal alveolar bone loss.

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 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient satisfying the following criteria will be included in this clinical study:
  • Patients with age between 16-25 years
  • Patients with either Angle's class I or class II malocclusion with moderate crowding in the anterior mandible(LII- 4-6mm) who requires extraction in the lower arch (tooth-size-arch-length discrepancy>5 mm)
  • Permanent dentition
  • Existence of all tooth in the mandibular arch (except third molars which may or may not be present)
  • Good oral hygiene and periodontal health
  • No smoking habit.

排除标准

  • medical conditions that would affect tooth movement (corticosteroid treatments, NSAIDs consumption, bisphosphonates, hyperparathyroidism, osteoporosis, uncontrolled diabetes)
  • Contraindication to oral surgery (medical, social, psychological)
  • Missing tooth in the mandibular arch
  • Presence of primary or supernumerary tooth in mandibular arch
  • Previous orthodontic treatment
  • Poor oral hygiene and current periodontal disease
  • Smoking habit.

结局指标

主要结局

Amount of Crowding Relieved

时间窗: 16 weeks

Measured with Little Irregularity index using Digital caliper

次要结局

  • Overall Alignment Time(16 weeks)
  • Marginal Alveolar Bone Loss(16 weeks)
  • Root resorption of mandibular anteriors(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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