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Orthognathic Surgery clinical trials

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NCT ID: NCT03986723 Completed - Clinical trials for Orthognathic Surgery

3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery

Start date: November 29, 2017
Phase:
Study type: Observational

Despite the shift from 2D towards 3D virtual treatment planning of orthognathic surgery, traditional plaster cast are still gold standard. The investigators aimed to compare the overall reliability and time efficiency of an digital workflow using 3D printed models, in comparison to the conventional plaster workflow. Twenty real-life cases were planned according to both workflows and timed by a single resident.

NCT ID: NCT03986710 Completed - Clinical trials for Orthognathic Surgery

Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: Single Surgeon Study

IPSCD-TIM-GS
Start date: April 2016
Phase:
Study type: Observational

Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical phase of their novel 3D virtual planning software, "IPS (Individual Patient Solutions) CaseDesigner (IPSCD)". Objectives The authors aim to test pre-release versions of the IPSCD software under real-world working conditions by a single surgeon.In specific, the authors aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time. Study design closed beta-phase Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon will run all the virtual planning steps with both conventional software (Maxilim) and the novel software. Timing of the eight major steps will be measured with a digital chronometer.

NCT ID: NCT03843138 Completed - Clinical trials for Orthognathic Surgery

Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: an International, Multi-centric, Prospective Study

3D IPSCD-TIM
Start date: May 2016
Phase:
Study type: Observational

Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical and the single surgeon (GS) closed beta-phase of their novel 3D virtual planning software, IPS (Individual Patient Solutions) CaseDesigner (IPSCD). Objectives The investigators aim to test pre-release versions of the IPSCD software under real-world working conditions in strictly selected university, general and private hospital settings. In specific, they aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time. Study design closed beta-phase; international, multi-centric, prospective study Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon and/or orthodontist will run all the virtual planning steps with the novel software. Timing of the eight major steps will be measured with a digital chronometer. One hundred and eight patient cases will be planned with the IPSCD software in the participating centers over a period of three months, in the order of respectively one, three and five cases per month per participating center. Investigators will register anonymized patient demographics (age, gender, clinical diagnosis, type of surgery), and provide feedback regarding the required time to complete the different surgical planning steps, regarding the number of failed alignments, and the occurrence of software bugs. Intergroup comparison of virtual planning time between the different centers will be analyzed. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon and/or orthodontist, or in comparison to the initial beta-testing phase results by GS.

NCT ID: NCT03796078 Recruiting - OSA Clinical Trials

Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea

Start date: April 30, 2018
Phase: N/A
Study type: Interventional

ABSTRACT OBJECTIVES: To study the correlation between pharyngeal airway volume (PAV), the clinical indicators of obstructive sleep apnea (AHI, ESS), and the impact of orthognathic surgery on them. METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center. During the study period: - Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1). - Assessment of PAS/PAV stability (relapse) at short term (1 month). 3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery. - Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist) - Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12). - Record of body mass index (BMI) (cm/Kg2) Main Objective: • Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA. Specific objectives: • Interrelate the degree of dentofacial deformity with the IAH. - Study the potential correlation between the volume of the VAS and the IAH. - Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS). - Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA. Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA. - To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA. - Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA. - Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term. - Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery. Hypothesis - H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term. - H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.

NCT ID: NCT03687307 Not yet recruiting - Clinical trials for Orthognathic Surgery

What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study

Start date: February 2019
Phase:
Study type: Observational

the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.

NCT ID: NCT03486951 Not yet recruiting - Clinical trials for Orthognathic Surgery

Outpatient Orthognathic Surgery: "AMBOST" a One Year Study

AMBOST
Start date: September 2018
Phase:
Study type: Observational

The aim of this prospective and observational study is to describe the conditions of orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole orthognathic procedures done. The investigator also wants to identify factors associated with an outpatient-to-inpatient shift, and factors associated with the duration of hospitalization.

NCT ID: NCT03433144 Withdrawn - Tranexamic Acid Clinical Trials

The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

TXA-OMFS
Start date: June 1, 2018
Phase: Phase 4
Study type: Interventional

This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery? If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.

NCT ID: NCT03357211 Completed - Clinical trials for Orthognathic Surgery

Accuracy of Maxillary Repositioning During Orthognathic Surgery

POMOCOBS
Start date: February 29, 2016
Phase: N/A
Study type: Observational

Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned using clinical, radiological and dental cast data. The result of this planning are occlusal splints. Orthognathic surgery had improved in the last decade with 3 dimensions computerized tomography scan (3D CT-Scan) planning and osteosynthesis implants. However the accuracy of the operative results compared to the planned ones has rarely been measured.

NCT ID: NCT03318757 Withdrawn - Clinical trials for Orthognathic Surgery

Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery

Start date: September 2020
Phase: Phase 4
Study type: Interventional

This research is being done to determine quantitative and qualitative differences in patients' post-operative pain levels following elective orthognathic surgery after the local administration of a liposomal bupivacaine injection. A primary objective is to determine whether using a liposomal bupivacaine injection placed locally at the conclusion of elective orthognathic surgery will decrease pain levels (as determined by VAS scores). A secondary objective is to examine whether using a long acting liposomal bupivacaine injection locally at the conclusion of elective orthognathic surgery leads to decreased use of narcotics post-operatively.

NCT ID: NCT02618993 Completed - Clinical trials for Orthognathic Surgery

Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy

Start date: December 2015
Phase: Phase 3
Study type: Interventional

The sensory innervation of the face depends on the trigeminal (fifth cranial) which is divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal and masseter muscle. The regional anesthesia of the face has grown in recent years for performing certain actions under light general anesthesia or sedation. The mandibular block is a simple and reliable technique but little used. Yet it reduces postoperative pain sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it also improves the visibility of the operative field during mandibular osteotomies reducing bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of action of the local anesthetic), the V3 block ropivacaine is not evaluated in the maxillofacial surgery.