Active — Not RecruitingNot Applicable

Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography

Egypt20 participantsStarted 2024-03-10

Plain-language summary

The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molars The patients will be selected according to the following criteria: 1. Patient with full permanent dentition. 2. Good oral hygiene. 3. None of the patients had received any orthodontic treatment. 4. Class II molar relationship. 5. Minimal or no crowding in the mandibular arch. 6. Non-extraction treatment plan with molar distalization. 7. Low angle cases. 8. No medical problems or active periodontal disease. Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization.

Who can participate

Age range

14 Years – 18 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: * Patient with full permanent dentition. * Good oral hygiene. * Class II molar relationship. * Non-extraction treatment plan with molar distalization. * Low angle cases. * medical problems or active periodontal disease. Exclusion Criteria: * The patients had received any orthodontic treatment. * Crowding in the mandibular arch. * Medical problems or active periodontal disease.

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

Linear distalization of maxillary teeth relative to pterygoid vertical (PTV) plane

Timeframe: Through study completion, maximum 18 months

Angular inclination of maxillary teeth relative to Frankfort horizontal (FH) plane

Timeframe: Through study completion, maximum 18 months

Molar relationship at end of distalization phase

Timeframe: Through study completion, maximum 18 months

Trial details

NCT IDNCT06308640

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-10

View on ClinicalTrials.gov More Class II Malocclusion trials

Plain-language summary

Who can participate

Age range

14 Years – 18 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.

What they're measuring

Linear distalization of maxillary teeth relative to pterygoid vertical (PTV) plane

Timeframe: Through study completion, maximum 18 months

Angular inclination of maxillary teeth relative to Frankfort horizontal (FH) plane

Timeframe: Through study completion, maximum 18 months

Molar relationship at end of distalization phase

Timeframe: Through study completion, maximum 18 months