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临床试验/NCT07399197
NCT07399197招募中不适用

Three-Dimensional Evaluation of Alveolar Bone Changes and Root Resorption After Orthodontic Traction of Unilateral Buccally Displaced Maxillary Canines Using Two Different Techniques: A Randomized Clinical Trial

Sana'a University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3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
招募中
入组人数
40
试验地点
1
主要终点
Mean Change in the Alveolar Bone Thickness

研究概览

简要总结

This clinical study used CBCT images to investigate the alveolar bone changes and root resorption in unilateral buccally displaced maxillary canines and adjacent teeth before and after orthodontic traction of unilateral BDMCs.

The CBCT images will also be used to compare these changes to the normal contralateral side. The study outcome is to compare the 3-D changes in the alveolar bone and dental roots between the 2 interventional techniques (segmentalT-loop and piggyback NiTi traction) methods.

详细描述

Buccally displaced eruptions of permanent maxillary canines occur in 0.8% to 5.2% of orthodontic cases. Patients are often motivated to request orthodontic treatment when they have crowded teeth and maxillary canines that come in buccally erupted.

The treatment of BDMC is challenging due to the limited labial alveolar bone and the potential risks of root resorption, bone loss, and gingival recession due to the movement of long and bulge roots, necessitating bodily movement with light and constant orthodontic force. The previous studies focused only on comparisons of root resorption, bone loss, and periodontal health before and after impacted canine traction. The previous studies on BDMC mainly included case reports that looked at various orthodontic traction methods. To our knowledge, no randomized clinical trial has been done to study the 3- D changes in the alveolar bone and root length after orthodontic traction of BDMCs.

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
Double (Care Provider, Outcomes Assessor)

盲法说明

This clinical trial will use a randomized design with equal allocation in a 1:1 ratio, blinding, and paralleling two groups.Computer-generated random sequencing using Microsoft Office Excel will performed. Opaque sealed envelopes will be used for allocation concealment. Blinding of the participants and operator will not possible because of the nature of the study. Blinding of the result evaluation will be done through data concealment during assessment.

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Yemeni ethnic patients.
  • Presence of unilateral BDMC.
  • The presence of a properly positioned and normally erupted contralateral canine.
  • Mild to moderate crowding.
  • The need for fixed orthodontic treatment.
  • No sagittal discrepancy

排除标准

  • History of severe facial trauma.
  • Previous orthodontic treatment.
  • Presence of bilateral BDMC.
  • Presence of developmental dental anomalies.
  • Presence of facial syndromes and bone metabolism disease.

研究组 & 干预措施

T-loop

Active Comparator

In patients randomized to the frictionless group, T-loops were fabricated using 0.017 X 0.025-inch TMA wire.

The posterior leg of the T-loops will be inserted in the auxiliary tube of the first molar, and the anterior leg engaged the canine bracket.

干预措施: T-loop (Device)

Piggyback double wire

Active Comparator

In patients randomized to the piggyback double wire method, all teeth in both maxillary and mandibular arches will be bonded with preadjusted edgewise brackets from the 0.022- in-slot MBT system.

干预措施: Piggyback double wire (Device)

结局指标

主要结局

Mean Change in the Alveolar Bone Thickness

时间窗: From baseline (before orthodontic traction) to the completion of orthodontic traction (an average of 8 months)

The mean change in the alveolar bone thickness will be measured in millimeters (mm) using CBCT scans.

Mean Change in the Alveolar Bone Height

时间窗: Baseline and Month 8

Alveolar bone height measured in millimeters (mm) using CBCT.

次要结局

  • Mean Change in Root Resorption(Baseline and Month 8)
  • Difference Between Two groups in Alveolar Bone Dimension Changes(Month 8 after the completion of canine traction.)

研究者

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

Mohammed Abdullah Abdullah Al-Hababy

Candidate in PhD of Orthodontics

Sana'a University

研究点 (1)

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