Clinical trials: Craniofacial Surgery
Craniosynostosis
Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery
This prospective observational study aims to evaluate the role of pleth variability index (PVI) and perfusion index (PI) monitoring in intraoperative hemodynamic control among pediatric patients undergoing craniosynostosis…
- Trial name
- PVI-CRANIO (NCT07657598)
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Muzaffer GENCER
Cleft Palate
Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair
The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects.
- Trial name
- NCT01500109
- Testing
- Oral acetaminophen, Ofirmev®, Opioid only
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Loma Linda University
Cleft Lip, Cleft Palate
Characterization of Cleft Lip and Palate Conditions in Guatemala
The purpose of this study is to compare types of and risk factors for cleft lip and palate in a Guatemalan population to a United States population.
- Conditions
- Cleft Lip, Cleft Palate, Cleft Lip and Palate
- Trial name
- NCT04725370
- Testing
- NA - survey instrument
- Where
- United States
- Volunteers
- 629 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Retrognathism, Prognathism
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy
The bilateral sagittal split osteotomy (BSSO) of the mandible is one of the most used surgical techniques to achieve a harmonious jaw relation in the context of orthognathic surgery.
- Conditions
- Retrognathism, Prognathism, Orthognathic Surgery, Neurosensory Disorder
- Trial name
- NCT05536596
- Testing
- Orthognathic Surgery, Melatonin 10 MG Oral Tablet, Hydroxycobalamin
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Universitat Internacional de Catalunya
Sedation, Emergence Delirium
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing…
- Trial name
- NCT05821972
- Testing
- Nebulization of dexmedetomidine and ketamine, Nebulization of dexmedetomidine
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Assiut University
Freeman-Burian Syndrome, Freeman-Sheldon Syndrome
Survey Study and Records Review of Treatment Outcomes in Freeman-Sheldon Syndrome
The purpose of this study is to evaluate the difference in diagnosis accuracy, treatment outcomes, patient perspectives, facial function and walking ability, emotional and social health, and respiratory complications between…
- Conditions
- Freeman-Burian Syndrome, Freeman-Sheldon Syndrome, Whistling Face Syndrome, Sheldon-Hall Syndrome
- Trial name
- FINDFSS (NCT05419245)
- Testing
- Guided Health History for Freeman-Burian Syndrome Questionnaire, Freeman-Burian syndrome Semi-Structured Quality of Life Interview, Medical Records Review
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Dufresne, Craig, MD, PC
Cleft Lip, Cleft Palate
Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes
Children who are born with cleft palate need surgery in order to correct the problem. The surgery is needed because the defect allows food to leak into the nose.
- Trial name
- NCT01380171
- Where
- United States
- Volunteers
- 1,295 people
- Sponsor
- Children's Healthcare of Atlanta
Dentofacial Deformities, Edema
Lymphatic Drainage Massage and Melatonin in Post-Orthognathic Surgery Pain and Edema
Lymphatic drainage massage is one of the most essential techniques for reducing edema. It is a very gentle, monotonous, slow, rhythmic massage applied to the skin's surface.
- Conditions
- Dentofacial Deformities, Edema, Pain
- Trial name
- NCT07062757
- Testing
- no intervention, lymphatic drainage massage, oral melatonin tablet
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bezmialem Vakif University
Craniofacial Surgery, Virtual Surgical Planning
Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction
The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry…
- Trial name
- NCT06970730
- Testing
- virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction
- Where
- Egypt
- Volunteers
- 15 people
- Sponsor
- Hams Hamed Abdelrahman
Malocclusion, Dentofacial Deformities
Augmented Reality for Orthognatic Surgery Patient Education
To evaluate whether the use of augmented reality (AR) for visualizing 3D models can be a valuable addition to patient education regarding orthognathic procedures compared to using only 2D visualization (on a computer screen).
- Conditions
- Malocclusion, Dentofacial Deformities, Patient Satisfaction, Informed Consent
- Trial name
- NARRATE (NCT06140043)
- Testing
- Patient consultation
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 60 people
- Sponsor
- University Medical Center Groningen
Surgical Complication, Paresthesia
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw.
- Conditions
- Surgical Complication, Paresthesia, Fracture, Nerve Injury
- Trial name
- NCT05205616
- Testing
- Sonopet ultrasonic saw, Reciprocating saw
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Surgical Infants on NG/NJ/J/G-tube Feeds, Tracheoesophageal Fistula
A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months
This is the 5th in a series of physiological studies to determine the amino acid requirements of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine requirements in infants when they are fed…
- Conditions
- Surgical Infants on NG/NJ/J/G-tube Feeds, Tracheoesophageal Fistula, Pierre-Robin Syndrome, Diaphragmatic Hernia
- Trial name
- INFORALTHR (NCT02364843)
- Testing
- Amino Acid: Threonine
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- The Hospital for Sick Children
DiGeorge Syndrome, Congenital Heart Defects
Infection in DiGeorge Following CHD Surgery
We propose a retrospective review of patients with DiGeorge syndrome having undergone cardiac surgery to evaluate the incidence of blood stream and/or surgical site infection.
- Trial name
- NCT00278005
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Children's Healthcare of Atlanta
Craniosynostoses, Hypovolemia
Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic…
- Conditions
- Craniosynostoses, Hypovolemia, Hemorrhage, Hemodynamic Instability
- Trial name
- CRASY-PRAM (NCT06263075)
- Testing
- Intraoperative monitoring
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Mandibular Hypoplasia, Relapse
Evaluation of Early Relapse After Mandibular Lengthening Surgery
The goal of this study is to evaluate whether the use of a bone graft substitute at the osteotomy site will result in better stability and diminish early relapse after mandibular lengthening surgery.
- Trial name
- NCT03710512
- Testing
- Bilateral sagittal split osteotomy
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Universitair Ziekenhuis Brussel
Craniosynostoses, Pain, Postoperative
Scalp Block Decreases Pain and Side Effects
Postoperative analgesia after corrective surgery of paediatric craniosynostosis is crucial in term of short and long-term outcomes.
- Trial name
- NCT04133467
- Testing
- scalp block
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Craniosynostosis
Efficacy of Amicar for Children Having Craniofacial Surgery
The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective in reducing blood loss in children undergoing craniofacial reconstruction surgery.
- Trial name
- NCT02229968
- Testing
- Amicar (ε-aminocaproic acid), normal saline
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's National Research Institute