- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07752498
Long-term Stability of Treatment With the Twin Block Appliance
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:
- 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?
- 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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Jönköping County
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Jönköping, Jönköping County, Suecia, 551 11
- The Institute of Postgraduate Dental Education
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Long term follow-up without additional orthodontic treatment
Patients that recieved treatment with Twin block, without having recieved additional treatment afterwards.
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Long term follow-up with additional orthodontic treatment
Patients that recieved treatment with Twin block and then also required additional treatment afterwards.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in horisontal overjet
Periodo de tiempo: From enrollment (T0) to follow up (T2), about 6 years later.
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The difference in horisontal overjet measured in millimeters at follow up (T2), compared with pre- (T0) and post-treatment (T1) values.
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From enrollment (T0) to follow up (T2), about 6 years later.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Molar relationship
Periodo de tiempo: From enrollment (T0) to follow up (T2), about 6 years later.
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Molar relationship at follow-up (T2), compared to molar relationship pre-(T0) and post-treatment (T1).
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From enrollment (T0) to follow up (T2), about 6 years later.
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Overbite
Periodo de tiempo: From enrollment (T0) to follow up (T2), about 6 years later.
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The difference in vertical overjet measured in millimeters at follow up (T2), compared with pre- (T0) and post-treatment (T1) values.
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From enrollment (T0) to follow up (T2), about 6 years later.
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Cephalometric data
Periodo de tiempo: From enrollment (T0) to follow up (T2), about 6 years later.
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Comparing cephalometric values of SNA, SNB and ANB pre- (T0), post-treatment (T1) and at follow-up (T2).
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From enrollment (T0) to follow up (T2), about 6 years later.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anders Magnusson, Med dr., Region Jönköping
Publicaciones y enlaces útiles
Publicaciones Generales
- 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. 2003 Nov;124(5):488-94; discussion 494-5. doi: 10.1016/S0889540603006425.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Dnr 2025-08312-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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