UnknownNot Applicable

Study to Measure the Effect of Part Time Versus Full Time Orthodontic Appliance Wear

United Kingdom62 participantsStarted 2013-12

Plain-language summary

The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods.

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Class II div 1 malocclusion(upper front teeth lying more forward than lower front teeth with upper front teeth proclined), * Overjet(horizontal difference between upper and lower front teeth) measuring minimum of 7mm, * Male subjects 12--14 years at the start of treatment, * Female subjects 11--13 years at start of treatment, * Willingness of the patient and parent to participate in the study. Exclusion Criteria: * No previous orthodontic treatment * No relevant medical history or craniofacial syndrome

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

remaining overjet measured with an orthodontic ruler

Timeframe: outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period

Cephalometric Changes

Timeframe: Outcome will be assessed after 12m of appliance wear and after 3 months of settling.

Trial details

NCT IDNCT02190630

SponsorQueen Mary University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Class II Division 1 Malocclusion trials

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.