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临床试验/NCT04338789
NCT04338789已完成不适用

Mandibular Molar Protraction Assisted by Temporary Anchorage Device and Piezoelectric Corticotomy

Jordan University of Science and Technology0 个研究点目标入组 30 人开始时间: 2016年12月2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
30
主要终点
Changes in the level of of Interleukin1-β

研究概览

简要总结

This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and root resorption in patients treated by molar protraction with piezocision performed early at the time of protraction (Group 1), piezocision performed 3 months after molar protraction (Group 2), and no piezocision molar protraction (Group 3).

详细描述

Detailed Description: Thirty-five subjects who presented with bilaterally extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: group 1 consisted of 20 subjects /20 molars where piezocision was performed immediately before molar protraction; group 2 consisted of 20 subjects/ 20 molars where molar protraction was carried on after 3 months of molar protraction with no piezocision; group 3 consisted of 20 subjects (40 molars) where protraction was carried out with no piezocision.

After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm. Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Periodontal parameters were measured and lower molar root resorption was assessed using Perapical radiographs.

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)

盲法说明

Blinding of either patient or clinician was not possible during treatment. However, partial blinding was possible. Orthodontic molar protraction was carried out by the clinician without knowing the GCF levels and the lab was blinded to the clinical findings. Also, periapical radiographs and study casts were masks during data collection.

入排标准

年龄范围
19 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age range from 19 to 30 years
  • •Bilaterally extracted mandibular first molar (first molar extracted more than one year ago and with a residual extraction space of more than 6 mm).
  • •Class 1 malocclusion where molar protraction is indicated.
  • •All permanent teeth are present except for the extracted mandibular first molars.
  • •Healthy periodontium (gingival index score ≤ 2, plaque index score ≤ 2 and probing depth < 4mm)

排除标准

  • •Previous orthodontic treatment
  • •Any systemic disease
  • •Poor Oral hygiene

研究组 & 干预措施

Group 1

Experimental

It consisted of 20 subjects with bilateral first molar extraction space where piezocesion was performed immediately before molar protraction on the left or right side of the patient.

干预措施: Piezocision (Other)

Group 2

Experimental

It consisted of 20 subjects with bilateral first molar extraction space where piezocesion was performed 3 months after molar protraction with no piezocision on the left or right side of the patient.

干预措施: Piezocision (Other)

Group 3

No Intervention

It consisted of 20 subjects (40 molars) where molar protraction was performed with no piezocesion.

结局指标

主要结局

Changes in the level of of Interleukin1-β

时间窗: 4 weeks

Detected in Gingival crevicular fluid (GCF). The periopaper was placed for 60 seconds in the mesiogingival sulcus of the lower second permanent molar and was transferred to an Eppendorf tube containing phosphate buffered saline.

Rate of molar protraction

时间窗: 1 year

Measured in mm/month from dental casts

次要结局

  • Periodontal parameters (Plaque, gingival health, periodontal pocket depth, alveolar bone height)(1 year)
  • Lower molar root resorption(1 year)

研究者

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

Elham Abu Alhaija

Professor

Jordan University of Science and Technology

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