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NCT07520682
The anterior gap is defined by a lack of contact between the upper and lower dental arches. It is mainly due to the persistence of infantile swallowing during and after childhood, i.e. interposition of the tongue between the two dental arches. Patients presenting with an anterior gap in adulthood are likely to develop functional sequelae (masticatory difficulties, dental loosening, periodontal disease, etc.) and aesthetic sequelae (edentulous smile, excess height of the lower third of the face compared to the upper and middle third). Patients who are diagnosed with this condition very often benefit from orthodontic-surgical treatment, comprising a period of orthodontics followed by orthognathic surgery to close the anterior gap. This is combined with lingual re-education to treat infantile swallowing. This lingual re-education is not always carried out, either because infantile swallowing has not been diagnosed, or because of a lack of cooperation on the part of the patient, or because of difficulties in finding a suitable specialist. When rehabilitation is introduced, it is sometimes only after surgery, and for a short time. For example, it has been observed that among all patients undergoing orthognathic surgery, those with an anterior gap were particularly at risk of surgical treatment failure, or recurrence in the short to medium term. The main reason cited was the persistence of infantile swallowing and consequent malpositioning of the tongue between the dental arches, creating permanent pressure on the lingual surface of the teeth and eventually leading to recurrence of the gap. Identifying patient management factors associated with postoperative recurrence of anterior hollowness in patients with infantile swallowing would enable us to adapt the management of these patients.
NCT05073757
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming. Our project aims to study the performance and safety of custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.
NCT07344441
To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery
NCT05271383
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for orthognathic surgery.
NCT05708521
This study aims to investigate pain management and satisfaction following orthognathic surgery, which is a type of surgery that corrects jaw and facial bone issues. This type of surgery can result in significant post-operative pain for participants, and the goal of this study is to find a way to manage this pain in a more effective and safe manner. The study will focus on the use of opioid pain medication and will compare two groups: one group will receive a standardized prescription plan. In contrast, the other group will receive a personalized prescription with a plan to taper the opioid medication. In the end, any unused opioid will be compared at the end of the 7-day post-discharge period between the two groups. This is important because excessive opioid prescription can either be diverted to the community or can be misused leading to opioid use disorders. Data will be collected from pre-surgery appointments, during the surgery and hospital stay, and follow-up appointments. The data collected will include participants' demographics, medical history, type of surgery, and information about the pain medication used. The study hypothesizes that the personalized prescription plan will result in less unused medication and higher satisfaction with pain management compared to the standardized prescription plan. The study will also stratify the participants into single-jaw surgery and double-jaw surgery groups to evaluate if any differences in the outcomes are observed. This study will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery. Furthermore, this study will also benefit society by providing insights into addressing the opioid crisis that is currently affecting many communities across North America.
NCT05009056
The unstable condylar position in the glenoid fossa is a critical problem for postsurgical instability after mandibular advancement with subsequent mandibular relapse. The habitual forward occlusion in class II patients creates unstable condyle to glenoid fossa relationship making it hard for clinicians to determine the amount of mandibular advancement. Splint therapy is considered as a preoperative reversible nonsurgical condylar repositioning option in addition to its adjunctive effect for pain relief in TMJ symptomatic patients. To minimize this relapse, presurgical functional appliance therapy has been proposed and has shown promising outcomes.
NCT06400355
The aim of this study is to test, whether mannitol infusion in different doses will affect recovery pattern? the investigators hypothesized that infusion of mannitol in doses of 0.5 gm/kg before recovery from anesthesia after orthognathic surgery shortens patients' recovery time, and improves recovery quality, as well as postoperative cognitive function better.
NCT06338982
The goal of this clinical trial is to investigate the hypothesis that there are none difference in the treatment result of orthognathic surgery on the lower jaw, with interoperative wisdom tooth removal rather than preoperative wisdom tooth removal. In patients with severe dental malocclusion combined with a dentofacial deformity. The main question it aims to answer are: • Is there a difference in the degree of complication and the patient's perception, with inter-operative wisdom tooth removal rather than pre-operative wisdom tooth removal. Participants will be will be divided into two groups, with one group having their wisdom teeth removed 6 months before their jaw moving surgery and the other group having their wisdom teeth removed in connection with their jaw moving surgery.
NCT06301204
The aim of this clinical study conducted in accordance with the information in the literature is to compare the effects of administering tranexamic acid during orthognathic surgery, at different doses. Specifically, investigators aim to compare the effects of administering 1 ampoule IV (approximately 3 mg/kg) and 2 ampoules IV (approximately 6 mg/kg), and evaluate their impact on intraoperative bleeding (ml), surgical duration (min), postoperative swelling, and intraoperative surgical field evaluation (Fromme Scale), by comparing them with control group (applying no drug administration) patient data.
NCT05316545
Using retrospective medical records to analyze the difference between the analysis of the correlation between operation time, blood loss, anesthesia methods, anesthesia medication, and postoperative recovery time
NCT03796078
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.
NCT05717322
All patients with skeletal deformity will undergo orthognathic surgery after orthodontic treatment. After surgery TENS electrodes( rubber electrodes with the same size 5.3×4.8 cm) will be Placed bilaterally on ant temporalis and bilaterally on superficial masseter muscle…Time : 30 min /3 times per week/ 6 weeks
NCT05184725
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure. Provision of education and information about the surgery can be a crucial component of the preoperative experience and is inversely related to levels of preoperative anxiety. However, resource constraints make face-to-face education sessions untenable, given cost considerations and time investment by trained health personnel. Interventions based on mobile health (mHealth) technologies, geared towards increasing familiarity with surgical procedures and hospital environments have been shown to help patients feel informed about possible benefits and risks of available treatment options. mHealth apps and Virtual Reality (VR) can offer patients experience in the perioperative environment that can be helpful in empowering patients and enhancing a more positive experience, while reducing stress. However, available applications focus only on providing informative content, neglecting the importance of patient empowerment with a more robust educational curriculum. According to this, the Software as a Medical Device (SaMD) CARINAE, aims to support patients and caregivers during the whole perioperative process. SaMD CARINAE consists of an mHealth mobile application for patients and caregivers, a Virtual Reality headset for patients, and a web application for healthcare professionals.
NCT05362383
Oral functions of patients are markedly diminished immediately after orthognathic surgery, and novel approaches are needed to accelerate their recovery. The aim of this study is to examine the usefulness of weekly applications of transcutaneous electrical nerve stimulation (TENS) for this purpose, based on evidence of its effectiveness in other types of patients with muscle alterations. The main objective is to determine whether weekly TENS applications can increase the bite force and jaw opening in patients undergoing orthognathic surgery and decrease their pain and inflammation
NCT01461031
The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.
NCT03986723
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.
NCT04353635
Patients with class III dentofacial deformity who are in need of surgical correction are now able to see the potential changes to their faces before the actual operation. Dolphin 3d is one of the few software packages that is used for orthognathic planning and prediction of soft tissue changes. The direct effect of the prediction procedure over patient's and surgeon decisions makes it important to guarantee a high level of accuracy of operational results prediction. This study is designed to investigate the accuracy of Dolphin 3d software for the prediction of postoperative soft tissue changes following specific surgical procedure which is the combined maxillary advancement and mandibular setback, commonly used for correction of class III facial deformity cases. The study data will be collecting retrospectively. The difference between the pre-operative soft tissue prediction and the 6-month postoperative results will be analysed. The results of this study will help to determine whether this software package is accurate enough to be considered as a surgical assistance tool helping both surgeons and patients in treatment planning and decision-making procedure respectively.
NCT03843138
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.
NCT03986710
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.
NCT01989715
Postural balance on both feet, characteristic of the human species, is possible by the tension of muscle of the whole body from toes to head. Body position depends on many inputs such as vision, vestibule, skin receptors, states of muscle tension receptors. Information is integrated in a complex nervous system via the ascending and descending pathways. The information is then analyzed to provide feedback on body position. Any variation of body position, induces a variation of the center of pressure. Impaired body positioncan cause pain (back pain, neck pain) or long-term deformation (including scoliosis or kyphosis). Maxillas position, via the activity of masseter and temporal muscles, acts on the muscle chain that controls posture. Incorrect positioning of the jaw in the three directions of space seems to create an asymmetric masticatory muscles activity and thus destabilize the muscle chain responsible for body position. Repositioning maxillas by orthognathic surgery could alter the body posture via changing the activity of the masticatory muscles. However, nowadays no clear link has been demonstrated between maxillas repositioning and body posture modification. The purpose of this study is to highlight the link between posture and jaws position, by analyzing the variation of the masticatory muscles activity and, the changes in body center of pressure before and after orthognathic surgery of jaws standardization. In this study each patient will be evaluated in terms of occlusion and body posture before surgery and after surgery (2 months) by the same protocol. The surgery will be performed in the Maxillofacial Surgery service - Pr BLANC and assessment will take place in the dentistry department - Prof. Salvadori La Timone Hospital, Marseille. The assessment includes the body posture study with a stabilometric platform (eyes open / eyes closed and with / without tooth contact), and analysis of the head orientation relative to the vertical. Electromyographic muscle masseter assessment (jaw with/without contact ) are devoted to check the evolution of the developed forces, and hand strength will be recorded using a dynamometer. All these data will be recorded for all the patients. Patients will be divided into four subgroups: (1) maxillary endognathia, (2) mandibular prognathism , (3) mandibular retrognathia and (4 mandible repositioning. Statistical analysis is aimed at validating or not the hypothesis of changes in body posture caused by surgical maxillas repositioning.