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Mandibular Fractures clinical trials

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NCT ID: NCT06349135 Not yet recruiting - Clinical trials for Mandibular Fractures

Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study

Start date: April 15, 2024
Phase:
Study type: Observational [Patient Registry]

Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study

NCT ID: NCT06338982 Not yet recruiting - Clinical trials for Impacted Third Molar Tooth

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

Start date: March 30, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06333197 Not yet recruiting - Clinical trials for Mandibular Fractures

Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The condylar region is the most frequent anatomical site for mandibular fractures . Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).

NCT ID: NCT05964140 Not yet recruiting - Mandible Fracture Clinical Trials

The MANTRA Trial (MANdibular TRauma and Antibiotic Use)

MANTRA
Start date: August 1, 2024
Phase: Phase 3
Study type: Interventional

1. FULL TITLE OF THE PROJECT Should we use post-operative antibiotics following surgery for patients with mandible fractures? The MANTRA trial (MANdibular TRauma and Antibiotic use) 2. SUMMARY OF RESEARCH (ABSTRACT) Research Question: Are post-operative antibiotics required following surgery for patients with mandible fractures? Background: Mandible fractures are the commonest facial fractures needing surgery and account for a significant percentage of the acute workload in Oral & Maxillofacial Surgery (OMFS) units. The UK records over 6000 new cases per year. Patients having surgery for mandible fractures have a theoretical risk of developing surgical site infection, due to the proximity of the fracture lines to the oral cavity microbes and the presence of foreign body (titanium fixation miniplates). For this reason, clinicians often prescribe antibiotics after surgery, to reduce the risk of infection. Previous systematic reviews and a multicentre cohort study performed by this team, revealed significant clinical variation in post-operative antibiotic prescription amongst UK OMFS clinicians and the presence of clinical equipoise. Antibiotic overuse can lead to antibiotic resistance and other antibiotic-related side effects; judicious antibiotic use and stewardship is of paramount importance. Aim: To determine whether post-operative antibiotics are required at all, following surgery for mandible fractures, and, if so, what is the most clinically- and cost-effective regimen Objectives: Primary Objective To conduct a Randomized Controlled Trial (MANTRA) in order to establish the non-inferiority (or not) of not giving post-operative antibiotics versus 2 other post-operative antibiotic regimens. An internal pilot phase will optimise recruitment and retention. Secondary Objectives - Measure the cost-effectiveness of the proposed antibiotic pathways - Assess patient and clinician acceptability to change clinical practice - Process evaluation to inform dissemination and implementation Methods: The investigators designed and propose the MANTRA RCT to compare 3 post-operative antibiotic approaches to prevent Surgical Site Infections (SSIs) following surgery for mandible fractures. The MANTRA trial is a large open label, multicentre study in NHS OMFS units. The 3 study arms represent the most common clinical pathways in the UK based on previous work; the control group is the approach prescribed by most UK OMFS clinicians. All patients will receive 1 dose of IV antibiotics (co-amoxiclav 1.2g, if no penicillin allergy, which is the most commonly used prophylactic antibiotic currently) on induction of anaesthesia, prior to their surgery. The participants will be randomised to the following (1:1:1): Group A: No further antibiotics Group B: 2 further postoperative IV doses of co-amoxiclav 1.2g Group C: 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy (Control). Trial processes will be optimised by an internal pilot phase ensuring we recruit, randomise, and retain participants with clear progression criteria. We will also conduct cost-effectiveness analyses and process evaluation for dissemination and implementation Timeline: Start of grant: 1st July 2023 Start of RCT / pilot: 1st January 2024 End of pilot: 30th June 2024 End of recruitment: 31st December 2026 End of follow-up: 30th June 2027 Completion: 31st December 2027 Impact and dissemination: - Practice changing outputs that standardise the use of antibiotics in mandible fractures in the NHS and provide a framework for other surgical prophylaxis research - A bespoke clinical dissemination plan via an engagement and training legacy - Cost-effectiveness data to inform policy making - A research legacy and change of culture in the specialty of OMFS

NCT ID: NCT05733221 Not yet recruiting - Mandible Fracture Clinical Trials

3D Printed Models for Mandibular Fracture Repair

Start date: March 2023
Phase: N/A
Study type: Interventional

The investigators will test the hypothesis that patients randomized to the intervention (3D printing with pre-bent plate) arm have less operative room time and less time for the critical part of the procedure than patients in the control arm (no 3D printing, current standards of care). Personalized medicine and care for fracture treatment.

NCT ID: NCT05444829 Not yet recruiting - Clinical trials for Mandibular Fractures

Specific Screw Holes Locating Surgical Guide and Pre-bent Plates

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow

NCT ID: NCT03839368 Not yet recruiting - Mandible Fracture Clinical Trials

Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates

Start date: April 2020
Phase: N/A
Study type: Interventional

In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages & simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.

NCT ID: NCT03761524 Not yet recruiting - Clinical trials for Mandibular Fractures

Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture

Start date: August 2019
Phase: N/A
Study type: Interventional

The aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.

NCT ID: NCT03747666 Not yet recruiting - Mandible Fracture Clinical Trials

Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture

Start date: November 2019
Phase: N/A
Study type: Interventional

Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

NCT ID: NCT03714035 Not yet recruiting - Clinical trials for Mandibular Fractures

Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages

Indices
Start date: October 30, 2018
Phase:
Study type: Observational

this study aims to correlate mandibular indices and different ages in a sample of Egyptian population.