Clinical trials: Craniofacial Surgery
Craniosynostosis
Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child
Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis.
- Trial name
- IRON KID (NCT03231085)
- Testing
- Ferrous fumarate or ferrostrane
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Montpellier
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Orthognathic surgery changes the skeletal framework of the upper airway, but its functional effect on sleep-disordered breathing remains poorly documented, particularly with respect to respiratory effort.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea, Obstructive, Dentofacial Deformities
- Trial name
- SUNRISE-ORTHO (NCT07910461)
- Testing
- Orthognathic surgery (BSSO with or without Le Fort I osteotomy), Sunrise mandibular jaw movement monitoring, Facial multidetector CT in natural head position
- Where
- Belgium
- Volunteers
- 25 people
- Sponsor
- CHR Sambre et Meuse Site Meuse
Craniofacial Abnormalities
Mandibular Slotplates
A new osteosynthesis system for orthognathic surgery was proposed.This system allows small intra-operative adjustments of the bone fragments during the osteosynthesis phase of the operation (also known as the slot principle).
- Trial name
- NCT03679377
- Testing
- Mandibular slotplate
- Where
- Belgium
- Volunteers
- 9 people
- Sponsor
- Universitair Ziekenhuis Brussel
Craniosynostoses
Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts
FGF23 is the cornerstone of phosphate / calcium / vitamin D metabolism: it is synthesized mainly by osteocytes and acts as a phosphaturizing agent, inhibitor of dihydroxyvitamin D, and inhibitor of synthesis and secretion of PTH…
- Trial name
- HYPO-BLASTES (NCT04159675)
- Testing
- osteoblast biology study
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Hospices Civils de Lyon
Maxillofacial Abnormalities, Post Procedural Discharge
Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery
Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions.
- Trial name
- DLMOF (NCT01983436)
- Testing
- Manual Lymphatic drainage
- Where
- 2 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Tours
Cleft Lip and Palate
Unilateral Cleft Repair in One Surgery With Pure Primary Healing
Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre
- Trial name
- NCT04108416
- Testing
- Cleft lip and palate repair
- Where
- Switzerland
- Volunteers
- 11 people
- Sponsor
- University Hospital, Basel, Switzerland
Cleft Palate, Cleft Lip
Targeting Surgeons' Decision-Making for Cleft Lip Surgery
Using separate prospective cohorts of patients who have lip revision and lip repair surgery, the objective of this clinical trial is to both qualitatively and quantitatively assess how surgeons integrate the objective measures…
- Trial name
- NCT03537976
- Testing
- Static Images and Facial Videos
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- Tufts University
Cleft Palate, Surgery
Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
This is a monocentric prospective randomized simple-blind designed study evaluating the superiority of the suprazygomatic maxillary nerve block in analgesia after cleft palate surgery compared with a control group.
- Trial name
- Suprazyg (NCT04023825)
- Testing
- suprazygomatic maxillary nerve block
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Recovery After Cleft Palate Surgery
Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery
A cleft deformity of the lip and/or palate is one of the commonest major birth defects. Primary surgery of cleft palates (CP) varies according to the different surgical teams.
- Trial name
- NCT02923869
- Testing
- Levobupivacaine, Bupivacaine
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Assiut University
Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate
Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency
Cleft lip and/or palate (CL/P) is the most common congenital malformation, with about one in 500 children born with CL/P in Sweden, corresponding to approximately 175 births annually.
- Trial name
- NCT05838261
- Testing
- Pharyngeal flap
- Where
- 6 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Umeå University
Cleft Lip, Cleft Palate +/- Lip
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
This study will evaluate whether adding a suprazygomatic maxillary nerve block to the standard palatal nerve block improves pain control after cleft palate repair surgery in children.
- Conditions
- Cleft Lip, Cleft Palate +/- Lip, Pain Management, Wound Dehiscence, Surgical
- Trial name
- NCT07892963
- Testing
- Palatal Nerve Block, Suprazygomatic Maxillary Nerve Block
- Volunteers
- 144 people
- Sponsor
- Children's National Research Institute
Craniosynostosis, Anesthesia
Influence of General Anesthesia on the Dynamic Changes in Brain Damage Markers During and After Craniosynostosis Operations in Infancy
The issue of anesthetics neurotoxicity is one of the most discussed topics in pediatric anesthesiology, thus it opens the question of the safety of commonly used anesthetics in the pediatric patient.
- Trial name
- TAnBrainDam (NCT05911139)
- Where
- Slovakia
- Volunteers
- 45 people
- Sponsor
- Comenius University
Dentofacial Deformities
Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis
Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.
- Trial name
- MandiFirst (NCT06907745)
- Testing
- Bimaxillary Osteotomy
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Postoperative Pain
A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting
The efficacy of three postoperative pain management regimens will be compared in patients undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to determine the best way of managing…
- Trial name
- NCT00405262
- Testing
- Ketorolac, Bupivacaine, ketorolac + bupivacaine
- Where
- Canada
- Volunteers
- 54 people
- Sponsor
- The Hospital for Sick Children
Craniosynostosis, Bleeding
Tranexamic Acid for Craniofacial Surgery
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.
- Trial name
- NCT00722436
- Testing
- Tranexamic acid, saline
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Pittsburgh
Craniotomy
Craniofacial Surgery Perioperative Registry
Craniofacial reconstruction procedures are undertaken in young children to improve appearance, prevent functional disturbances, and enhance psychosocial development.
- Trial name
- NCT00658242
- Where
- United States
- Volunteers
- 249 people
- Sponsor
- Children's Hospital of Philadelphia
Dentofacial Deformities
Stability of Two Designs of Patient Specific Osteosynthesis For Fixation of LeFort 1 Osteotomy in Orthognathic Surgery
A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of…
- Trial name
- NCT05522348
- Testing
- Stability of a two piece PSI deign in splintless maxillary orthognathic surgery, Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
- Where
- Egypt
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Cairo University
Dentofacial Deformity
Orthognathic Surgery and Postoperative Antibiotic Use
Currently there is debate in the literature as to the recommended length of postoperative antibiotics in patients undergoing orthognathic surgery.
- Trial name
- NCT01823523
- Testing
- Cefazolin, Cephalexin, Clindamycin
- Where
- Canada
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Atlantic Center for Oral and Maxillofacial Surgery
Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate
Expiratory Muscle Strength Training for Hypernasal Speech in Children
When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency.
- Conditions
- Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence
- Trial name
- NCT05492266
- Testing
- Expiratory Muscle Strength Training, Maintenance Training
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Noel Jabbour
Drug-resistant Focal Epilepsies in Pediatric Population
Genetic and Electrophysiologic Study in Focal Drug-resistant Epilepsies
Brain somatic mutations are increasingly recognized as a major cause of focal epilepsies. These include mTOR pathway mutations underlying cortical malformations such as focal cortical dysplasia and hemimegalencephaly, and SLC35A2…
- Trial name
- GENEPHY (NCT02890641)
- Testing
- Sampling of blood, frozen resected tissues, and cerebrospinal fluid (CSF)
- Where
- France
- Volunteers
- 450 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild