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Long-term Stability of Treatment With the Twin Block Appliance

2026年8月3日 更新者:Region Jönköping County

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

72

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Jönköping County
      • Jönköping、Jönköping County、スウェーデン、551 11
        • The Institute of Postgraduate Dental Education

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The patient cohort was originally recruited and treated from December 2018 to October 2020 The inclusion criteria for the previous study were healthy patients according to the American Society of Anaesthesiology Classification (ASA I and II), aged 8-14 years at treatment start and with an overjet of 6 mm or more together with an incomplete lip closure.

Exclusion criteria were severe chronic conditions such as asthma and allergy, neuropsychiatric disorders, craniofacial syndromes, and previous orthodontic treatment. Recruitment of the patients continued until the number of participants met the estimated sample size.

This patient group were then contacted again for recruitement to the present study during June 2026 to August 2026.

説明

Inclusion Criteria:

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

Exclusion Criteria:

None

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Difference in horisontal overjet
時間枠: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.
From enrollment (T0) to follow up (T2), about 6 years later.

二次結果の測定

結果測定
メジャーの説明
時間枠
Molar relationship
時間枠:From enrollment (T0) to follow up (T2), about 6 years later.
Molar relationship at follow-up (T2), compared to molar relationship pre-(T0) and post-treatment (T1).
From enrollment (T0) to follow up (T2), about 6 years later.
Overbite
時間枠:From enrollment (T0) to follow up (T2), about 6 years later.
The difference in vertical overjet measured in millimeters at follow up (T2), compared with pre- (T0) and post-treatment (T1) values.
From enrollment (T0) to follow up (T2), about 6 years later.
Cephalometric data
時間枠:From enrollment (T0) to follow up (T2), about 6 years later.
Comparing cephalometric values of SNA, SNB and ANB pre- (T0), post-treatment (T1) and at follow-up (T2).
From enrollment (T0) to follow up (T2), about 6 years later.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Anders Magnusson, Med dr.、Region Jönköping

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月10日

一次修了 (推定)

2026年8月30日

研究の完了 (推定)

2026年12月20日

試験登録日

最初に提出

2026年8月3日

QC基準を満たした最初の提出物

2026年8月3日

最初の投稿 (実際)

2026年8月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月7日

QC基準を満たした最後の更新が送信されました

2026年8月3日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

Data collection is not yet complete.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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