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临床试验/NCT03450278
NCT03450278已完成不适用

Effect of Micro-osteoperforation on the Rate of Canine Retraction: A Split Mouth Randomized Controlled Trial

Cairo University0 个研究点目标入组 36 人开始时间: 2015年12月1日最近更新:
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
主要终点
Rate of maxillary canine retraction

研究概览

简要总结

The current study Is a split-mouth Randomized Controlled Trial that was performed to investigate three dimensionally, using digital models and Cone Beam Computed Tomography imaging, the effect of micro-osteoperforations (MOPs) on the rate of tooth movement in a canine retraction model.

详细描述

Sample size calculation was carried out and resulted in enrolment of 18 female patients requiring bilateral upper first premolars extraction and canine retraction with maximum anchorage. The sample was recruited from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.

After placement of the fixed orthodontic appliance, leveling and alignment proceeded till 0.016" × 0.022" NiTi upper archwire. Indirect skeletal anchorage was then prepared using TADs inserted bilaterally between the upper 1st molar and 2nd premolar, and the patient was referred for upper 1st premolars extraction.

Three months after extraction, 0.017" × 0.025" stainless-steel upper archwire was inserted and three vertically aligned MOPs were randomly allocated and performed in one side using a single TAD, while the other side served as control. The three MOPs were performed distal to the canine, equidistant in the extraction space. Bilateral canine retraction was then commenced using NiTi closing coil springs delivering 150 gms of force. Before leaving the clinic, a pain questionnaire was given to each patient.

Data were collected from monthly upper impressions, which were poured into stone models and scanned to obtain sequential digital models (T0, T1, T2, T3 & T4), in addition to pre- and post-retraction maxillary CBCT images.

The assessed outcomes were the rate of canine retraction per month, the total distance travelled by the upper canines, first molars anchorage loss, tipping, torque and rotation of upper canines and first molars, canine root resorption and finally the pain related to MOP procedure. Statistical analysis was performed on the gathered data and results were withdrawn.

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 30 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Malocclusion that requires bilateral extraction of the maxillary first premolars and canine retraction with maximum anchorage; Class II division 1 and bimaxillary dentoalveolar protrusion cases.
  • •Full permanent dentition with exception of the third molars.
  • •Good oral hygiene and periodontal condition.

排除标准

  • •Medically compromised patients.
  • •Patients suffering from any congenital, hereditary or systemic diseases.
  • •Chronic use of any medications affecting orthodontic tooth movement (e.g. corticosteroids, hormonal therapy, NSAIDs)
  • •Patients with dental anomalies (e.g. enamel hypoplasia, root dilacerations in maxillary canines).
  • •Patients with medical conditions that contraindicate surgeries (e.g. bleeding tendency and immunocompromised patients).
  • •Radiographic evidence of bone loss.

研究组 & 干预措施

control

No Intervention

canine retraction without any means of acceleration.

micro-osteoperforation

Experimental

canine retraction accelerated with micro-osteoperforation

干预措施: micro-osteoperforation (Procedure)

结局指标

主要结局

Rate of maxillary canine retraction

时间窗: 4 months of canine retraction

distance (mm) moved by the canine distally per month

次要结局

  • Maxillary canine tipping, torque and rotation(4 months of canine retraction)
  • Maxillary first molar anchorage loss(4 months of canine retraction)
  • Pain caused by the micro-osteoperforation procedure(1 week after the micro-osteoperforation procedure)
  • Maxillary first molar tipping, torque and rotation(4 months of canine retraction)
  • Maxillary canine root resorption(4 months of canine retraction)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Aboalnaga

Assistant Lecturer, Dr. Amira Ahmed Mohamed Anis Aboalnaga

Cairo University

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