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Enrolling by Invitation

NCT Number: 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:

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The Institute of Postgraduate Dental Education

Jönköping, Jönköping County, 551 11, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difference in horisontal overjet

    Time frame: 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.

Secondary outcomes

  1. Molar relationship

    Time frame: 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).

  2. Overbite

    Time frame: 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.

  3. Cephalometric data

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Region Jönköping County

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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