CompletedNot Applicable

Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair

Poland40 participantsStarted 2020-12-07

Plain-language summary

This is a prospective observational cohort study of consecutive patients with cleft lip and palate deformity undergoing cleft repair at the Institute of Mother and Child in Warsaw. Cleft morphology will be captured with photo and intraoral camera before routine surgery at around 8 months. Furthermore, wound healing at 3 months postoperative will be assessed.

Who can participate

Age range

6 Months – 15 Months

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 orofacial cleft, who undergo routine cleft repair Exclusion Criteria: * missing datasets * no signed consent for research

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

True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age

Timeframe: Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.

Trial details

NCT IDNCT04616690

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-17

View on ClinicalTrials.gov More Cleft Lip and Palate trials