IFPE (Invisalign First Palatal Expander) (NCT06230484) | Clinical Trial Compass
UnknownNot Applicable
IFPE (Invisalign First Palatal Expander)
100 participantsStarted 2024-02
Plain-language summary
Malocclusions with narrow upper arches are usually treated in the mixed dentition with a traditional bonded maxillary expander. Most recently, a new design of a removable expander by Align was brought to our attention. In this prospective clinical study, the investigators will compare the patient-reported treatment outcomes and the dental-skeletal treatment effects on palatal dimensions. With this study, the investigators will have a better understanding of this newly developed appliance and its application in early orthodontic treatment.
Who can participate
Age range
6 Years – 12 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:
* Patients in mixed dentition with 6 present on both Right and Left in the upper arch
* Patients with transverse maxillary deficiency (presence of unilateral or bilateral crossbite, or intermolar width (as measured where the palatal groove meets the gingival margin of the first molar) of 33 mm or less)
Exclusion Criteria:
* multiple and/or advanced caries,
* missing teeth due to aplasia, trauma, or deep caries,
* supernumerary teeth,
* congenital craniofacial malformations or congenital or acquired systematic disease,
* previous orthodontic treatment
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
inter-canine, inter-molar, and palatal width
Timeframe: one year
2
Qualitative measurements from questionnaire- level of pain and discomfort