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临床试验/NCT04191070
NCT04191070Unknown不适用

A Three Dimensional Comparative Evaluation of Distal Movement of Entire Maxillary Dentition Using Infrazygomatic Crest Miniscrews and Zygomatic Miniplates: 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 42 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
42
试验地点
2
主要终点
soft tissue profile changes

研究概览

简要总结

The main objective of this study is to quantify the distal movement of maxillary central incisors and molars achieved with infrazygomatic miniscrews in comparison with zygomatic miniplate anchorage.

详细描述

Premolar extraction treatment with multibracketed system and reinforced anchorage has been a common modality for correcting maxillary incisor crowding or class II malocclusion due to maxillary protrusion in nongrowing patients. Treatment of class II malocclusion without extraction frequently requires distalization of maxillary molars into class I relation by means of extraoral or intraoral forces.

Extra oral headgear traction is the oldest and most commonly used method to correct class II buccal segment relationship by restricting the forward growth of maxilla and /or distalizing the maxillary molars. This distalizes not only 1st molar but also maxillary 1st and 2nd premolars via transseptal fibers. Headgear is seldom an option in adults due to aesthetics and compliance concerns. The disadvantages of extra-oral appliances have motivated many investigators to develop the mechanics of intraoral molar distalization.

Various intraoral non-compliance appliances like magnets, distal jet, jones jig, pendulum appliance etc. have been used to distalize the maxillary molars. However, in these appliances, anchorage loss characterized by protrusion of maxillary incisors and an increase in overjet is seen. Also, considerable amount of relapse occured when the distalized molars were used as anchorage for the retraction of anteriors and premolar teeth.

Absolute skeletal anchorage available 24 hours a day is an alternative method for molar distalization. It provides stationary anchorage for various tooth movements without the need for active patient compliance and with no undesirable side effects. Inter radicular miniscrews placed between the roots limit the amount of distalization possible as they come in contact with surrounding roots during tooth movement. Also, proximity of miniscrews to the roots may lead to failure of screw anchorage.

Infrazygomatic crest is a site for miniscrew placement. It has been used successfully to provide skeletal anchorage for en-masse anterior retraction, canine retraction, and intrusion of maxillary posterior teeth. Anatomically, it is a pillar of cortical bone at the zygomatic process of maxilla. It has two cortical plates - sinus floor and buccal cortical plate. This allows for bicortical fixation and contributes to better primary stability of miniscrew. A thicker bone allows greater miniscrew biting depth and more osseous contact . A new method for maxillary dentition distalization with miniscrews implanted in the infrazygomatic crest (IZC) region was proposed by Lin. There is no interference with tooth movement by miniscrews placed here and the technique is easy to master .

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
17 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Non growing patients
  • Bilateral Class II molar relationship, defined by at least end-to-end molar relationship.
  • No or minor crowding in the mandible.
  • Treatment completion without any permanent teeth extracted (excluding third molars).
  • Both 1st and 2nd maxillary molars present on the side with a Class II relationship.
  • Horizontal to average growth pattern.

排除标准

  • Subjects with a history of fixed orthodontic treatment.
  • Crossbite
  • Vertical growth pattern
  • Any systemic disease affecting bone and general growth
  • Poor oral hygiene
  • Cleft patients
  • Patients who fail to follow up or undergo complete treatment

结局指标

主要结局

soft tissue profile changes

时间窗: 34 months

soft tissue profile changes after distalization evaluated on lateral cephalogram and the raters- orthodontist, laypersons,patients,parents and general dentists will assess changes in facial appearance on a visual analog scale with profile photographs

distal movement of maxillary molars and central incisors measured in mm at crown and root levels

时间窗: 28 months

. distal movement of maxillary molars and central incisors measured in mm at crown and root levels achieved with infrazygomatic crest miniscrew in comparison with zygomatic miniplates on Cone Beam Computed Tomography

root resorption of maxillary teeth

时间窗: 28 months

root resorption of maxillary incisors, canines, premolars and molars evaluated on Cone Beam Computed Tomography before and after distalization with infrazygomatic crest miniscrew in comparison with zygomatic miniplates

occlusal status comparison

时间窗: 34 months

occlusal status changes pre and post treatment will be assessed using PAR index(peer assessment rating between 2 groups)

patient experiences and quality of life with zygomatic miniplates and infrazygomatic crest miniscrews

时间窗: 34 months

patient experiences and quality of life with zygomatic miniplates and infrazygomatic crest miniscrew assessed using questionnaires given to patients for evaluating patient attitude,pain perception and quality of life at different time intervals.

次要结局

  • airway changes(28 months)
  • mandibular plane angle(28 months)
  • transverse changes(28 months)
  • movement of maxillary central incisors and molars in vertical plane(28 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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