Orthognathic Surgery

11

Review clinical trials related to Orthognathic Surgery. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Tooth and Bone-borne Cutting/Repositioning Guide and Patient-specific Implant(PSI)

Dentofacial deformity refers to a group of disorders characterized by malocclusion and facial asymmetry resulting from developmental abnormalities of the maxilla and mandible, which cause morphological and positional anomalies of the jaws. Compared with the traditional orthodontics-orthognathic surgery-orthodontics treatment protocol, the surgery-first approach has witnessed a continuous expansion of its clinical application scope. Nevertheless, academic controversies persist regarding its indication boundaries, postoperative jaw stability, and adaptive changes of the temporomandibular joint. In orthognathic surgery, computer-aided design/computer-aided manufacturing (CAD/CAM) surgical guides indirectly determine the three-dimensional spatial positions of the maxilla and mandible through occlusal relationships. The tooth-bone dual-supported osteotomy and positioning guide combined with pre-bent patient-specific implants (PSIs) forms a novel surgical guide system that enables independent and direct positioning of the maxilla. Theoretically, this system can eliminate errors derived from mandibular positional instability and thereby improve surgical accuracy. However, comparative studies investigating the clinical application of these two types of guides in surgery-first orthognathic surgery are still lacking. This prospective, randomized, controlled, single-blind clinical study aimed to explore the clinical value of PSIs and conventional CAD/CAM guides in surgery-first orthognathic surgery, with primary outcomes focusing on surgical accuracy, postoperative jaw stability, and temporomandibular joint alterations. The findings will provide evidence-based medical support for the expanded application of this novel technique in precision orthognathic surgery.

Participants needed: 50
Trial details
Age: 18-40Biological sex: AllType: InterventionalSponsor: Peking Union Medical CollegeUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

Age ranged from 18 to 40 years old. [+4]

Patients who refused to participate in the present study. [+5]

Status: Not yet recruiting

Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery

This randomized controlled clinical trial evaluates the effect of preemptive analgesia on postoperative pain outcomes in adult patients undergoing orthognathic surgery. Participants scheduled for bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia will be randomized to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving standard postoperative analgesia without preoperative medication. The study aims to determine whether the administration of pre-surgical analgesics reduces postoperative pain intensity and analgesic requirements during the early postoperative period. Pain will be assessed using a standardized pain scale at multiple time points following surgery, and secondary outcomes will include postoperative analgesic consumption and patient satisfaction with pain control. This investigation seeks to contribute evidence supporting multimodal analgesic strategies and improved postoperative pain management in patients undergoing orthognathic surgery.

Participants needed: 72
Trial details
Phase: Phase 4Age: 21-65Biological sex: AllType: InterventionalSponsor: University of Puerto RicoUpdated: May 6, 2026Locations: 1
Eligibility criteria

Adults aged 21 to 65 years. [+3]

Pregnancy or breastfeeding. [+7]

Status: Recruiting

Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates

In this research the investigators aim to minimize the use of more hardware in the fixation of the orthognathic surgery cases. The objective of this study is to assess the accuracy of the plan transfer with two customized titanium plates versus four customized titanium plates.

Participants needed: 10
Trial details
Age: 18-40Biological sex: AllType: InterventionalSponsor: Cairo UniversityUpdated: Feb 18, 2026Locations: 2
Eligibility criteria

Patients with no signs or symptoms of active TMDs. [+1]

Patients who refused to be included in the research. [+2]

Status: Recruiting

Effect of Orthognathic Surgery on Plantar Pressure and Posture

Orthognathic surgery leads to changes in the three-dimensional position of the jaws, which may result in alterations in head and neck posture as well as overall body posture. These postural changes are also expected to influence plantar pressure distribution. This study aims to evaluate the direction and magnitude of these changes by assessing posture and plantar pressure measurements before and after orthognathic surgery. Postural analysis and plantar pressure measurements will be performed preoperatively and at the 6-month postoperative follow-up in patients undergoing orthognathic surgery. In order to allow a reliable comparison, a control group consisting of non-operated individuals will also be included. The range of natural changes observed in the control group will be determined, and the outcomes will be compared between the surgical and control groups. By comparing preoperative and postoperative measurements, this study aims to evaluate the effects of orthognathic surgery on body posture and plantar pressure distribution. The findings are expected to contribute to the identification of parameters that should be considered in postoperative evaluation and rehabilitation. Furthermore, the results will provide valuable information regarding the postural and plantar pressure changes observed in patients following orthognathic surgery.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ayşenur DindarUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

Study Group (Orthognathic Surgery Group)

Status: Not yet recruiting

Accuracy of Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries

The goal of this clinical trial is to evaluate of the accuracy maxilla fixation using custom plates on nasal buttress only via minimally invasive approach versus using custom plates on nasal and zygomatic buttresses via conventional approach. The main question it aims to answer is: • Is the minimally invasive approach accurate and stable ? Researchers will compare minimally invasive technique to the traditional technique of fixation of the maxilla bone to see if it is as accurate and stable. Participants will: * Undergo surgey * Follow up visits weekly for a month then on a monthly basis for 5 more months.

Participants needed: 30
Trial details
Biological sex: AllType: InterventionalSponsor: Cairo UniversityUpdated: Dec 31, 2025
Eligibility criteria

Patients with dentofacial disharmony and misalignment requiring bimaxillary orth... [+2]

Patients who refused to be included in the research. [+2]

Status: Recruiting

Simulation of Facial Soft Tissue in Orthognathic Surgery

Orthognathic surgery consists of rebalancing the position of the jaws, taking into account functional criteria (tooth engagement, tooth/lip ratio, breathing, etc.) and aesthetic criteria. It has become much more accurate in recent years thanks to the advent of osteosynthesis plates and the contribution of three-dimensional imaging. Three-dimensional imaging makes it possible to simulate fairly accurately the surgical procedures and bone displacements required. However, the effect of these bone displacements on the soft tissues (skin, subcutaneous tissue, muscles) does not make it possible, with today's digital tools, to simulate the final aesthetic result and in particular to anticipate the sometimes significant postoperative changes to the face. Many patients are worried about these post-operative morphological changes and would like to have a precise idea of how they will look after surgery. Being able to offer them, before surgery, a visual solution simulating the final aesthetic appearance would be essential in this respect. The aim of the study is to validate the predictions provided by the digital face model on a series of patients scheduled for orthognathic surgery by comparing the simulation of the morphological result of the operation, provided by our algorithm (SPOC), with the actual result assessed on a scan taken 6 months after the operation.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Annecy GenevoisUpdated: Nov 17, 2025Locations: 1
Eligibility criteria

Patient over 18 ; [+3]

Patient with maxillary disjunction ; [+7]

Status: Recruiting

Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery

This prospective randomized controlled trial aims to compare the effects of kinesio taping and hilotherapy on postoperative edema, pain, and trismus in patients undergoing bimaxillary orthognathic surgery.

Participants needed: 36
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: Medipol UniversityUpdated: Jun 5, 2025Locations: 1
Eligibility criteria

Patients scheduled to undergo bimaxillary orthognathic surgery (Le Fort I + BSSR... [+3]

Presence of systemic disease or immunosuppressive medication [+3]

Status: Not yet recruiting

Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia

Maxillary hypoplasia in CLP deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from CLP repair.Turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related to the congenital cleft deformity, Midfacial hypoplasia is commonly treated by performing conventional Le Fort surgery to displace the maxilla anteriorly and stabilization afterward with rigid fixation along with orthodontics treatment. . Midface hypoplasia cleft patient has the following characteristics: concave facial profile, inverted nasal tip, wide alar base, acute nasolabial angle, and excessive exposure of sclera. Intraoral findings are anterior and posterior crossbite, CLP, accentuated curve of Spee, Class III dental malocclusion, multiple missing teeth, oronasal communication, and residual cleft. Speech disturbances are also usually present due to velopharyngeal incompetency and oronasal communication.

Participants needed: 22
Trial details
Age: 12-40Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Feb 28, 2025
Eligibility criteria

Cleft patients either cleft alveolus or cleft alveolus and palate. [+2]

Non- cleft cases . [+3]

Status: Recruiting

Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model

The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and aesthetic appearance of thepatient. Both aspects are equally important to achieve optimal results. When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2 .

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: IRCCS Azienda Ospedaliero-Universitaria di BolognaUpdated: Dec 4, 2024Locations: 1
Eligibility criteria

Patients undergoing orthognathic surgery and preoperative radiographic study wit... [+3]

patients with cleft lip-palate, facial malformations and/or syndromes (syndromes... [+1]

Status: Recruiting

Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking

Dentofacial deformities refer to morphological anomalies of the jaws. Their development during growth determines the shape of the lower third of the face and the type of dental occlusion. A maxillo-mandibular dysmorphosis associates morphological modification of the face and anomaly of the occlusion. If these anomalies are most often hereditary, they also depend on acquired factors such as swallowing, breathing, sucking or phonation disorders. Angle's classification defines three classes of dental occlusion: class I, when the ratio between the maxillary and mandibular first molars is normal, class II when the upper molar is too far forward, and class III when it is too far back. Class II and III dysmorphoses can result in an alteration of the masticatory function, pain (TMJ, headaches) or sleep apnea. At the same time, they cause patients to experience a decrease in self-esteem, anxiety and social discomfort. Class II and II usually require orthodontic treatment and orthognathic surgery to correctly align the jaws. This surgery has a positive impact on the dental occlusion and the functions concerned, but also on the facial morphology, all of which often leads to an improvement in the patient's quality of life. Standardized photographs presenting control subjects (class I) and patients (class II and class III) before and after surgery will be included in an approximately 10 min video sequence. Naive participants will look at this sequence during which the faces of the controls and the patients - before and after surgery - will alternate, with the instruction being free visual exploration of the images. The total fixation durations in defined areas of interest (eyes, nose, mouth, chin) will be recorded with an eye tracking device and the results will be processed using a dedicated software.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: Jul 11, 2024Locations: 1
Eligibility criteria

Naïve subject with regard to dentofacial deformities and their management [+3]

Subject familiar with dentofacial deformities and their management (e.g., health... [+2]

Status: Not yet recruiting

Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars

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.

Participants needed: 150
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Kimie Bols ØstergaardUpdated: Apr 1, 2024Locations: 1
Eligibility criteria

Patients scheduled for surgical correction of facial deformities involving BSSO... [+1]

Fully erupted and well-functioning mandibular third molar [+8]