MARPE in Patients With Cleft Lip and Palate (NCT04354116) | Clinical Trial Compass
UnknownNot Applicable
MARPE in Patients With Cleft Lip and Palate
Brazil44 participantsStarted 2020-01-10
Plain-language summary
The objective of this randomized controlled study will be to evaluate the dental and skeletal effects of maxillary protraction with a facemask, associated with MARPE and Class III elastics in patients with unilateral cleft lip and palate (CLP) with maxillary retrusion, compared to HYRAX type maxillary expanders. The investigators will examine differences in treatment times, along with skeletal, dental and soft tissue changes.
Who can participate
Age range
6 Years – 13 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 with cleft lip and palate;
* 6 to 13 years before orthodontic treatment, with sagittal deficiency of the facial middle third;
* Angle Class III malocclusion, or mesial step of the deciduous second molars, and anterior crossbite;
* ANB less than 0˚, Wits less than -2 mm and the distance from point A to the perpendicular nasion less than 0 mm.
Exclusion Criteria:
* Previous orthodontic treatment;
* Other craniofacial anomalies;
* Inadequate maxillary denture for placement of a expander.
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
The primary outcome will be the degree of anterior movement of the maxilla after treatment).
Timeframe: 6 months
Trial details
NCT IDNCT04354116
SponsorPontifícia Universidade Católica de Minas Gerais