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临床试验/NCT06763900
NCT06763900已完成不适用

Comparison of the Effectiveness of Corticotomy-Assisted Different Miniplate and Intermaxillary Elastic Applications After Growth Spurt in Individuals with Skeletal Class III Malocclusion

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月14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
20
试验地点
1
主要终点
Maxillomandibular sagittal changes

研究概览

简要总结

This prospective randomized clinical study aimed to evaluate the effectiveness of corticotomy-assisted maxillary protraction with three different miniplate and intermaxillary elastic applications after corticotomy in patients with skeletal Class III malocclusion.

详细描述

In acrylic splint group (AS) and palatal miniscrew group (MS), an acrylic splint containing hooks in the upper molar region was prepared and cemented. In the MS group, two miniscrews were used in the palatal region for additional anchorage. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery.

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
None

入排标准

年龄范围
13 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Skeletal Class III malocclusion
  • •ANB angle between 0 and -4°
  • •normal or horizontal growth pattern
  • •anterior crossbite or edge-to-edge incisor relationship
  • •permanent dentition

排除标准

  • •requirement for maxillary expansion
  • •pseudo-Class III malocclusion
  • •inadequate oral hygiene
  • •missing tooth in the upper dentition

研究组 & 干预措施

Miniplate Group (MP)

Experimental

An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region. Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1).

干预措施: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction (Device)

Acrylic Splint Group (AS)

Experimental

An acrylic splint containing hooks in the upper molar region was prepared and cemented to the upper dentition. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1).

干预措施: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction (Device)

Palatal Miniscrew Supported Acrylic Splint Group (MS)

Experimental

An acrylic splint containing hooks in the upper molar region was prepared and cemented to the upper dentition. Two miniscrews were used in the palatal region for additional anchorage. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1).

干预措施: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction (Device)

结局指标

主要结局

Maxillomandibular sagittal changes

时间窗: Through study completion, an avarage of 6 months

Investigation of Angular changes in SNA (°), SNB (°), ANB (°) measurements. Investigation of Distance changes in Wits (mm), A-Na Perp (mm), Co-A (mm), A-VRL (mm), and B-VRL (mm) measurements.

Vertical changes

时间窗: Through study completion, an avarage of 6 months

Investigation of Angular changes in Y-axis angle (°), SN-GoGN (°), SN-PP (°), Jarabak ratio measurements. Investigation of Distance changes in A-HRL (mm) measurement.

Dentoalveolar changes

时间窗: Through study completion, an avarage of 6 months

Investigation of Angular changes in U1-SN (°), U1-PP (°), IMPA (°) measurements. Investigation of Distance changes in Overjet (mm), Overbite (mm), U1-VRL (mm), and U6-VRL (mm) measurements.

Soft tissue changes

时间窗: Through study completion, an avarage of 6 months

Investigation of Angular changes in soft tissue convexity (°), NA-Pog (°) measurements. Investigation of Distance changes in VRL-prn (mm), VRL-Is (mm), VRL-li (mm), VRL-pog (mm), and ANS-Me (mm) measurements.

次要结局

未报告次要终点

研究者

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

Ahmet Yağcı

Professor

TC Erciyes University

研究点 (1)

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