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临床试验/NCT06833034
NCT06833034招募中不适用

To Compare the Effectiveness of a Novel Closed Exposure Technique With Removal of Bone Tissue and a Conventional Technique During Treatment of Palatally Impacted Maxillary Canines by Closed Surgical Exposure and Fixed Orthodontic Appliance

Malmö University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年3月7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
发起方
入组人数
66
试验地点
2
主要终点
Treatment time for the canine to be exposed in the oral cavity

研究概览

简要总结

A multi-center Randomized Clinical Trial, (RCT) on treatment effectiveness of two different closed surgical exposure techniques, one including additional bone removal and a second conventional without removal of additional bone, during treatment of palatally impacted maxillary canines.

A comparison between the two methods regarding the anchorage situation for the incisors will be performed as well.

Introduction Surgical exposure of impacted maxillary canines together with orthodontic treatment has long been advocated. Closed exposure with placement of an auxiliary attachment with a chain, followed by traction of the canine with orthodontic forces is commonly clinical used to avoid complications with the open procedure (Kokich 2004). Both open and closed methods and orthodontic treatment are one of the most time-consuming orthodontic treatments. Therefore, it is valuable to try to find methods which can reduce the total treatment time and make the treatments as comfortable as possible for the patient.

To reduce the treatment time, study I investigates a novel strategy for traction of the canine. Another strategy to reduce the treatment time might be to facilitate the movement of the canine by additional bone removal in the eruption direction out to the alveolar crest. This has been used of a few orthodontists in one clinic for some years. No negative side-effects have been seen. There are, however, no studies for comparison of the two techniques.

Aim The primary aims of this Randomized Clinical Trial (RCT) is to evaluate the treatment effectiveness of two different surgical closed exposure techniques of palatally impacted canines before the orthodontic treatment; a) with removal of bone in traction direction and b) without removal of bone in traction direction and to evaluate the anchorage situations.

Outcome variables The outcome variables will be: 1) Treatment time for the canine to be exposed in the oral cavity; 2) Treatment time for the canine to be in the dental arch and 3) Treatment time for the canine to have reached the right position in the dental arch.

Subjects Sixty-six patients between 10-18- years, will be recruited to the study. Patients with palatally impacted maxillary canines are consecutively recruited at three orthodontic clinics in Lund, Karlshamn and Ängelholm.

详细描述

Study Title: Comparing Novel and Conventional Techniques for Treating Palatally Impacted Maxillary Canines

Study Overview: This clinical study aims to compare the effectiveness and patient experiences of two different techniques used to treat palatally impacted maxillary canines. These are teeth that have not properly emerged into the mouth and are instead located in the palate. The study will focus on two specific techniques: a novel closed exposure technique that involves the removal of bone tissue, and a conventional traction technique.

Study Objectives:

Effectiveness and Patient Experience: The primary goal is to evaluate and compare the effectiveness of the novel and conventional techniques in treating palatally impacted maxillary canines. Additionally, the study will assess patient experiences, particularly focusing on pain and discomfort during the treatment process.

Anchorage Situation: The study will also compare the anchorage situation for the incisors (front teeth) when using the novel closed exposure technique versus the conventional technique.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Months 至 18 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with palatally impacted maxillary canine on one side, in sector 2-4 and with angle <45º are included.

排除标准

  • •Patients with clefts or syndromes
  • •Patients with earlier orthodontic treatment
  • •Patients with canines with angle >45º (fig.1)
  • •Patients with canines with impacted canines in sectors 1 or 2

研究组 & 干预措施

The conventional surgical method

Active Comparator

The conventional surgical method usually used in the clinic

干预措施: The novel surgical method (Procedure)

The novel surgical method

Experimental

Additional bone removal in intendet direction of tooth movement

干预措施: The conventional surgical method (Procedure)

结局指标

主要结局

Treatment time for the canine to be exposed in the oral cavity

时间窗: 24 months

The primary outcome measure for this study is the treatment time required for the palatally impacted maxillary canine to be exposed in the oral cavity. This will be measured in months from the start of the treatment until the canine is visible.

次要结局

  • Treatment time for the canine to align and reach its final position(24 months)

研究者

发起方
Malmö University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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