This study aims to evaluate clinical outcomes, patient-reported quality of life, the precision of surgical guides used for placing orthodontic mini-screws, and potential complications associated with the use of palatal temporary skeletal anchorage devices (TSADs) in orthodontically treated patients. The main questions it aims to answer are:
* What is the clinical effectiveness of palatal TSADs in orthodontic treatment outcomes?
* How do palatal TSADs affect the quality of life in orthodontic patients?
* How accurately do surgical guides transfer the digitally planned positions of mini-screws to their actual positions?
* What are the complications associated with the use of palatal TSADs in orthodontic treatment?
Participants will:
* Receive orthodontic treatment involving the placement of palatal TSADs
* Complete validated, standardized questionnaires assessing quality of life
* Be evaluated for skeletal and dental changes and monitored for clinical and technical complications throughout the course of treatment
Who can participate
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:
* Presence of a malocclusion requiring palatal temporary skeletal anchorage devices (TSADs)
* No previous treatment involving TSADs
* Lack of systemic comorbidities
* Signed informed consent (and parental consent for minors)
Exclusion Criteria:
* Presence of uncontrolled systemic diseases or conditions that contraindicate orthodontic treatment or the placement of mini-screws
* Poor oral hygiene
* Allergies to materials used in mini-screws or associated orthodontic appliances
* Lack of patient consent for study participation
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
Change in maxillary width before and after TSAD-supported orthodontic treatment
Timeframe: Baseline (pre-treatment) and through completion of orthodontic treatment (up to 24 months).
Trial details
NCT IDNCT07311473
SponsorHospital of the Ministry of Interior, Kielce, Poland