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临床试验/NCT07752498
NCT07752498Enrolling By Invitation不适用

Long-term Stability of Treatment With the Twin Block Appliance

Region Jönköping County1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
72
试验地点
1
主要终点
Difference in horisontal overjet

研究概览

简要总结

The objective of this observational study is to investigate the long-term stability of treatment with the Twin block appliance in a patient group previously treated with a Twin block appliance. The main questions it aims to answer are:

  1. Does treatment with the Twin block appliance give a lasting treatment result or does the bite relapse over time due to different factors such as short treatment time, compliance or the patient's natural growth pattern?
  2. How many patients that had received treatment with Twin block appliance required additional treatment with fixed appliances and for what reason?

Researchers will compare the patients present bite at (T2) by using study casts and cephalometric x-rays and compare this data with previous registrations made pre- (T0) and post-treatment (T1). Additional factors, such as how much relapse a patient has on average, will also be investigated.

详细描述

Orthodontic treatment during growth is called interceptive orthodontics. The objective is to affect the growth of the jaws and the position of the teeth with the assistance of a removable orthodontic appliance. One such appliance is the Twin block appliance, which is used to treat patients with an Angle class II malocclusion (Clark et al., 2022). The prevalence of Angle class II malocclusion is approximately 25% (Proffit et al., 2013).

There is however a lack of studies on the long term treatment stability of the Twin block appliance (Ehsani et al., 2015). Treatment with removable appliances also carry a great cost for both the individual, the parents and for society as a whole (Permert et al., 1998). The objective of the present study is to present guidelines concerning which patients that would benefit the most from treatment with Twin block appliance over time.

The present study will use a previous patient material consisting of 72 patients from the study by Frilund et al., (2023) "Patient compliance with Twin Block appliance during treatment of Class II malocclusion: a randomized controlled trial on two check-up prescriptions" to review the long term stability of treatment with Twin block appliance. These 72 patients were previously treated with a Twin block appliance. Their records will be reviewed to find patients who have had no additional orthodontic treament, and these patients will be asked to participate in the present study. If they accept, their present bite (T2) will be registered by study casts and with a cephalometric x-ray. This data (T2) will then be compared with their study casts and cephalometric data before treatment start (T0) and after treatment (T1). The main variables that will be investigated are overjet, overbite and molar relationship, as well as cephalometric values. The collected material will also be dichotomized into two groups, one with optimal current status with a neutral molar relation and a horizontal overjet of 4 mm or less, and one with a suboptimal current status presenting an angle class II molar relationship and/or an overjet greater that 4 mm.

The patients that recieved additional orthodontic treatment after their treatment with Twin block appliance will also be investigated to compare the reason for them having additional treatment and to investigate if the primary reason was relapse or other additional factors.

Statistical analysis of collected data will be perfofmed with the appropriate stastical models, depending on if the data has a normal distribution or not.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient participated in the previous study "Patient compliance with Twin Block appliance during treatment of Class II malocclusion: a randomized controlled trial on two check-up prescriptions" .Eur J Orthod.
  • https://doi.org/10.1093/ejo/cjac046

排除标准

  • 未提供

研究组 & 干预措施

Long term follow-up without additional orthodontic treatment

Patients that recieved treatment with Twin block, without having recieved additional treatment afterwards.

Long term follow-up with additional orthodontic treatment

Patients that recieved treatment with Twin block and then also required additional treatment afterwards.

结局指标

主要结局

Difference in horisontal overjet

时间窗: From enrollment (T0) to follow up (T2), about 6 years later.

The difference in horisontal overjet measured in millimeters at follow up (T2), compared with pre- (T0) and post-treatment (T1) values.

次要结局

  • Molar relationship(From enrollment (T0) to follow up (T2), about 6 years later.)
  • Overbite(From enrollment (T0) to follow up (T2), about 6 years later.)
  • Cephalometric data(From enrollment (T0) to follow up (T2), about 6 years later.)

研究者

发起方
Region Jönköping County
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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