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Набор по приглашению NCT07752498

Long-term Stability of Treatment With the Twin Block Appliance

Наблюдательное Malocclusion, Angle Class II Overbite (Excessive) Horizontal Overbite (Excessive) Deep Treatment Outcome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Malocclusion, Angle Class II, Overbite (Excessive) Horizontal, Overbite (Excessive) Deep, Treatment Outcome. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

The study has recieved ethical approval from the ethical board at the University of Linköping, Dnr 2025-08312-02. All patients will have to give their informed consent to participate in the study by signing a consent form.

Results will be published in appropriate medical journals and at interdisciplinary conferences and lectures.

Первичные конечные точки

  • Difference in horisontal overjet [Срок оценки: From enrollment (T0) to follow up (T2), about 6 years later.]
Вторичные конечные точки (3)
  • Molar relationship [Срок оценки: From enrollment (T0) to follow up (T2), about 6 years later.]
  • Overbite [Срок оценки: From enrollment (T0) to follow up (T2), about 6 years later.]
  • Cephalometric data [Срок оценки: From enrollment (T0) to follow up (T2), about 6 years later.]

Критерии участия

Критерии включения

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. 2023. https://doi.org/10.1093/ejo/cjac046

Критерии исключения

None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 1 центр
  • The Institute of Postgraduate Dental Education — Jönköping

Публикации

  • Permert L, Karlander EL, Wilhelm E. Treatment of malocclusions in children and adolescents at a public dental service clinic in Sweden: extent and cost. Swed Dent J. 1998;22(5-6):187-93. PMID 9974202
  • Cacciatore G, Ugolini A, Sforza C, Gbinigie O, Pluddemann A. Long-term effects of functional appliances in treated versus untreated patients with Class II malocclusion: A systematic review and meta-analysis. PLoS One. 2019 Sep 6;14(9):e0221624. doi: 10.1371/journal.pone.0221624. eCollection 2019. PMID 31490945
  • Ehsani S, Nebbe B, Normando D, Lagravere MO, Flores-Mir C. Short-term treatment effects produced by the Twin-block appliance: a systematic review and meta-analysis. Eur J Orthod. 2015 Apr;37(2):170-6. doi: 10.1093/ejo/cju030. Epub 2014 Jul 22. PMID 25052373
  • O'Brien K, Wright J, Conboy F, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I, Berk NW. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 2: Psychosocial effects. Am J Orthod Dentofacial Orthop. 200 PMID 14614414
  • Frilund E, Sonesson M, Magnusson A. Patient compliance with Twin Block appliance during treatment of Class II malocclusion: a randomized controlled trial on two check-up prescriptions. Eur J Orthod. 2023 Mar 31;45(2):142-149. doi: 10.1093/ejo/cjac046. PMID 35968672

Идентификаторы

NCT: NCT07752498 · Dnr 2025-08312-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗