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临床试验/NCT06858670
NCT06858670撤回不适用

Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars

Hanoi Medical University3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3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
撤回
发起方
入组人数
20
试验地点
3
主要终点
Curve of Wilson at Second Molar

研究概览

简要总结

This study aims to evaluate the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar) will be recruited.. Using a split-mouth design, one side will receive the intervention (auxiliary segmental lingual appliances), while the other side will serve as the control. The variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. Measurements will be taken on digital impressions at baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after applying the auxiliary segmental lingual appliances. The effectiveness will be assessed by comparing the two groups.

详细描述

This study focuses on evaluating the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. The study will recruit patients who exhibit an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar). A split-mouth design will be employed, where one side of the mouth will receive the intervention (auxiliary segmental lingual appliances), and the other side will serve as the control.

The primary variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. These measurements will be taken using digital impressions at three different time points: baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after the application of the auxiliary segmental lingual appliances.

The study aims to compare the effectiveness of the auxiliary segmental lingual appliances by analyzing the differences between the intervention and control sides. This comparison will help determine the impact of the appliances on achieving a more balanced and functional occlusal plane, potentially improving orthodontic treatment outcomes for patients with malocclusion issues.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

There will be no masking in this study. Both the patient and the outcome assessor will know which side will receive the intervention (auxiliary segmental lingual appliances).

入排标准

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

入选标准

  • Patients undergoing labial fixed orthodontic treatment.
  • Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar).
  • Patients willing to participate and provide informed consent.

排除标准

  • Patients with limited mouth opening and gagging reflex preventing placement of auxiliary segmental lingual appliances.

研究组 & 干预措施

Auxiliary Segmental Lingual Appliances Intervention in One Side

Experimental

In this arm, patients will receive the intervention of auxiliary segmental lingual appliances on one side of the mouth. The intervention aims to level the Curve of Wilson by adjusting the lingual inclination and leveling the lingual cusps of the mandibular second molar.

干预措施: Auxiliary Segmental Lingual Appliances (Procedure)

Control in Another Side

No Intervention

In this arm, patients will not receive the intervention of auxiliary segmental lingual appliances on another side of the mouth.

结局指标

主要结局

Curve of Wilson at Second Molar

时间窗: Baseline, 6 months, 9 months.

This measure evaluates the angle between the occlusal plane of the second molar and the mandibular arch occlusal plane. Measurements will be taken using digital impressions.

Distance from Mesiolingual Cusp of Second Molar to Occlusal Plane of First Molar

时间窗: Baseline, 6 months, 9 months.

This measure evaluates the distance from the mesiolingual cusp of the second molar to the occlusal plane of the first molar. Measurements will be taken using digital impressions.

Distance from Distolingual Cusp of Second Molar to Occlusal Plane of First Molar

时间窗: Baseline, 6 months, 9 months.

Description: This measure evaluates the distance from the distoolingual cusp of the second molar to the occlusal plane of the first molar. Measurements will be taken using digital impressions.

次要结局

  • Curve of Wilson at First Molar(Baseline, 6 months, 9 months.)

研究者

发起方
Hanoi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nguyen Ngoc Hoa

Principal Investigator

Hanoi Medical University

研究点 (3)

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