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Long-term Stability of Treatment With the Twin Block Appliance

3 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

72

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in horisontal overjet
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Molar relationship
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Anders Magnusson, Med dr., Region Jönköping

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 juli 2026

Primaire voltooiing (Geschat)

30 augustus 2026

Studie voltooiing (Geschat)

20 december 2026

Studieregistratiedata

Eerst ingediend

3 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 augustus 2026

Eerst geplaatst (Werkelijk)

7 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Dnr 2025-08312-02

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Data collection is not yet complete.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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