Clear Aligners vs Fixed Appliances for Molar Distalization Using Infrazygomatic Crest Screws (NCT07714603) | Clinical Trial Compass
CompletedNot Applicable
Clear Aligners vs Fixed Appliances for Molar Distalization Using Infrazygomatic Crest Screws
Turkey (Türkiye)37 participantsStarted 2024-06-06
Plain-language summary
This study compares three different methods of moving upper back teeth backward (distalization) to create space for crowded or protruding teeth, all supported by small temporary screws placed in the cheekbone area (infrazygomatic crest screws). Participants were randomly assigned to one of three treatment types: traditional fixed braces (Pitts21 system), Invisalign clear aligners, or ClearCorrect clear aligners. The study measures how effectively each method moves the back teeth, how long treatment takes, and how comfortable and practical each method is for patients. The goal is to help orthodontists and patients choose the most effective and efficient treatment option for this type of tooth movement.
Who can participate
Age range
13 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:
* Skeletal Class I (ANB angle 0-4°), dental Class II malocclusion treatable with molar distalization
* Need for unilateral or bilateral distalization of the first molars in the range of 2-4.5 mm
* Chronological age between 13 and 18 years, regardless of skeletal age
* Normal or hypodivergent growth pattern (SN-GoGn \< 39°)
* Mild to moderate maxillary crowding (less than 6 mm) and minimal or no mandibular crowding (less than 3 mm)
* No previously extracted maxillary teeth, excluding third molars
* Erupted permanent second molars
* Good oral hygiene
* Healthy periodontal tissues
Exclusion Criteria:
* Need for orthodontic tooth extraction or functional appliance therapy
* Presence of systemic disease
* Congenital or acquired craniofacial deformity involving the condyle or mandible
* Poor patient cooperation
* History of allergy to any metal
* Pre-existing root resorption prior to treatment
* Previous orthodontic treatment
* Abnormal position, depth of impaction, or close proximity to adjacent anatomical structures (sinus, neurovascular structures) of the maxillary third molar that would make its surgical extraction risky
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
1
Amount of Maxillary Posterior Tooth Distalization
Timeframe: From the date of infrazygomatic crest miniscrew placement and initiation of distalization force (T0) until the end of the active distalization phase (T1), assessed up to 13 months