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Cleft Lip clinical trials

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NCT ID: NCT04422964 Recruiting - Clinical trials for Cleft Lip and Palate

Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect (3D Obturator) - Pilot Trial

Pilobtur
Start date: June 12, 2020
Phase: N/A
Study type: Interventional

Congenital malformations of the orofacial area are the most common congenital malformations in children with an incidence of 1.8 children with orofacial cleft per 1000 healthy births in the Czech Republic. The care of children with cleft facial defects is multidisciplinary, centralized and takes place from birth to adulthood. At the University Hospital Brno, the treatment for patients with orofacial cleft is provided by the Cleft Center (CC) of the University Hospital Brno. The main specialties that form the basis of CC include plastic surgery, pediatric anesthesiology and neonatology. Patients with facial cleft defects are divided into 2 main groups based on the embryological causes of clefts: 1/ patients with cleft lip, jaw with or without cleft palate (total cleft) and 2/ patients with isolated cleft soft and hard palate. Anesthesia in children with orofacial clefts is specific not only to the age of the patients, but mainly to the cleft itself. Anesthesiology management, and especially intubation of these patients, are often difficult due to the nature of the defect with high incidence of complications such as difficult airway, desaturation, laryngospasm or bradycardia. In addition, tissue damage including soft tissue of the lip, alveolar arch, palate and nasal septum as well as skeleton of the premaxilla and nasal septum during intubation is seen in approximately 90% of patients. To facilitate intubation, improve anesthesiology management and safety of pediatric patients with orofacial cleft, investigators will develop an individualized protective tray from a silicone material, that will be used during intubation to cover the defect of the alveolar arch and palate. A mold for casting of a protective tray, will be created on a 3D printer on bases of 3D scan. Use of the protective tray would facilitate intubation, decrease anesthesiologic complications and protect soft and hard tissues of the cleft palate and upper jaw during intubation.

NCT ID: NCT04422847 Recruiting - Clinical trials for Cleft Lip and Palate

Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect

3D obturator
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Congenital malformations of the orofacial area are the most common congenital malformations in children with an incidence of 1.8 children with orofacial cleft per 1000 healthy births in the Czech Republic. The care of children with cleft facial defects is multidisciplinary, centralized and takes place from birth to adulthood. At the University Hospital Brno, the treatment for patients with orofacial cleft is provided by the Cleft Center (CC) of the University Hospital Brno. The main specialties that form the basis of CC include plastic surgery, pediatric anesthesiology and neonatology. Patients with facial cleft defects are divided into 2 main groups based on the embryological causes of clefts: 1/ patients with cleft lip, jaw with or without cleft palate (total cleft) and 2/ patients with isolated cleft soft and hard palate. Anesthesia in children with orofacial clefts is specific not only to the age of the patients, but mainly to the cleft itself. Anesthesiology management, and especially intubation of these patients, are often difficult due to the nature of the defect with high incidence of complications such as difficult airway, desaturation, laryngospasm or bradycardia. In addition, tissue damage including soft tissue of the lip, alveolar arch, palate and nasal septum as well as skeleton of the premaxilla and nasal septum during intubation is seen in approximately 90% of patients. To facilitate intubation, improve anesthesiology management and safety of pediatric patients with orofacial cleft, we will develop an individualized protective tray from a silicone material, that will be used during intubation to cover the defect of the alveolar arch and palate. A mold for casting of a protective tray, will be created on a 3D printer on bases of 3D scan. Use of the protective tray would facilitate intubation, decrease anesthesiologic complications and protect soft and hard tissues of the cleft palate and upper jaw during intubation.

NCT ID: NCT04381078 Recruiting - Clinical trials for Cleft Lip and Palate

Methods of Providing Information Prior to an Alveolar Bone Graft

Start date: December 9, 2020
Phase: N/A
Study type: Interventional

Patients born with a cleft of the lip and/or palate may have a gap in the bone in the roof of their mouth and in the area of bone where the teeth develop. These patients require an alveolar bone graft (ABG) to allow the eruption of the maxillary canine teeth amongst other reasons. The optimal time to carry this out is between the ages of nine and eleven. Whilst the patients will have had interventions as infants, this is often the first procedure a child born with a cleft lip and/or palate is likely to comprehend. An audio-visual guide has been developed by the Great Ormond Street Hospital Dental Department for children undergoing an ABG. It explains the reason for the procedure, what the process will involve and advice regarding postoperative care. This study will try ascertain whether providing information to patients and parents in this manner reduces anxiety, improves understanding of why the procedure was undertaken and post-operative care. Children between the ages of eight and twelve ready for this procedure at Great Ormond Street Hospital will be enrolled. They will be allocated into two groups during their assessment appointment. The control will be given standardised verbal and written information, whilst the experimental group will also be given the animation. The level of anxiety and understanding of the procedure will be measured after the intervention/control information and once again when the patient attends for their pre-surgical assessment two to three months later. This study aims to see whether the patient and parent anxiety is reduced and knowledge regarding the procedure is improved when utilising this of kind audio-visual guide for children. This will indicate whether it is worthwhile committing resources to the development of similar animations for other procedures.

NCT ID: NCT04354116 Recruiting - Clinical trials for Cleft Lip and Palate

MARPE in Patients With Cleft Lip and Palate

Start date: January 10, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04342234 Recruiting - Cleft Palate Clinical Trials

Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.

Start date: March 5, 2020
Phase:
Study type: Observational

This study is to develop a neural network to compute palatal three dimensional (3D) geometry by using routinely taken intraoral/palatal photographs and palatal casts of infants with cleft lip and palate deformity for reducing cleft lip and palate treatment burden. Data of palatal casts and palatal images of cleft patients routinely treated at the University Hospital Basel will be analyzed.The collection of large data helps in developing a neural network that will allow the computation of the 3D geometry from single photographs.

NCT ID: NCT04234971 Recruiting - Clinical trials for Cleft Lip and Palate

Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate

Start date: June 14, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM/BMP will have reduced post-operative pain scores,reduced operative times,and similar rates of bone healing compared to conventional ICBG.

NCT ID: NCT04150783 Recruiting - Nasal Obstruction Clinical Trials

Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes

Start date: November 1, 2019
Phase:
Study type: Observational

The purpose of this study is to use computers to simulate airflow in 3D construction of your nasal cavity generated from cone beam CT images. The results from computer simulations will help researchers identify the severity of cleft-induced nasal dysfunction and assess the impact of current treatment in restoring breathing function. The ultimate goal is to improve post-surgery outcomes to restore nasal breathing function to normal levels.

NCT ID: NCT04049058 Recruiting - Palate, Cleft Clinical Trials

Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context

ORTHOQOL
Start date: June 30, 2019
Phase:
Study type: Observational

The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment. The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.

NCT ID: NCT03922438 Recruiting - Clinical trials for Nasoalveolar Fistula (Defect)

Clinical Assessment of Usage of Cleft Margin Flap With Anterior Palatal Closure in Closure of Naso-alveolar Defect.

Start date: October 10, 2018
Phase: N/A
Study type: Interventional

During primary cleft lip repair in patients who were born with cleft lip and palate, usage of cleft margin flap with anterior palatal closure will be done in an attempt to close the Naso-alveolar fistula (defect) that usually occur and remain in those patients post-operatively.

NCT ID: NCT03891719 Recruiting - Clinical trials for Cleft Lip, Unilateral

Correction of the Unilateral Cleft Lip Nasal Deformity With Sliding Chondrocutaneous Flap and Autologous Cartilage Graft

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Cleft lip and cleft palate are the most common birth defects of craniofacial development. The surgical repair of this deformity requires comprehensive management plans and well cooperating interdisciplinary cleft teams. Secondary cleft rhinoplasty remains one of the most challenging procedures and aims for restoring nostril symmetry, enhancing nasal function, and improvement of aesthetic outcomes.