An interventional study of 3D stereophotogrammetric imaging and 3D CT-imaging with cone-beam CT in Craniofacial Abnormalities, Maxillofacial Abnormalities and Cleft Lip, sponsored by Radboud University Medical Center. Status unknown at 3 sites in Netherlands. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2007-07-27.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic
The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.
123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.
This study's planned enrollment of 450 is above the median of 44 across 77 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Cleft Palate, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Craniofacial Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months.
All postoperative changes in functionality at 1 year
patients' satisfaction of facial proportions at 1 year
surgeons' satisfaction of the 3D planning platform at 1 month
This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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