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Long-term Stability of Treatment With the Twin Block Appliance

2026년 8월 3일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

72

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Jönköping County
      • Jönköping, Jönköping County, 스웨덴, 551 11
        • The Institute of Postgraduate Dental Education

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Difference in horisontal overjet
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Molar relationship
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Anders Magnusson, Med dr., Region Jönköping

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 10일

기본 완료 (추정된)

2026년 8월 30일

연구 완료 (추정된)

2026년 12월 20일

연구 등록 날짜

최초 제출

2026년 8월 3일

QC 기준을 충족하는 최초 제출

2026년 8월 3일

처음 게시됨 (실제)

2026년 8월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 3일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Data collection is not yet complete.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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