CompletedNot Applicable

Removable Devices in Overjet Reduction

Italy50 participantsStarted 2023-12-01

Plain-language summary

The goal of this clinical trial si to compare two removable devices used to treat the mandibular retrusion in growing patients. The main questions it aims to answer are: * the efficacy of the two devices in the reduction of the overjet * the neuromuscolar effects developed on the stomatognatic system Participants will be instructed in the use and maintenance of the devices and will be checked every 15-30 days for one year.

Who can participate

Age range

9 Years – 15 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: * skeletal class II relationship, * complete eruption of upper first premolars * presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index). Exclusion Criteria: * IOTN (INDEX OF ORTHODONTIC TREATMENT NEED) index \> 4; * presence of epilepsy, * systemic disease, * TMD, or periodontal disease; * lack of written informed consent from a parent or legal guardian.

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

Changes in the horizontal distance between the upper and lower incisors

Timeframe: 12 months

Trial details

NCT IDNCT06955637

SponsorUniversity of L'Aquila

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-27

View on ClinicalTrials.gov More Skeletal Class II Malocclusion trials