Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
10 participants
OBSERVATIONAL
2024-02-01
2025-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets
NCT04331028
Ultrasound Guided Autologous Blood Injection in Temporomandibular Joint Dislocation
NCT06244134
Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects
NCT05360511
Randomized Clinical and Radiographic Study
NCT06609720
Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using Concentrated Growth Factor (CGF) Versus Blood Clot (BC)
NCT06012331
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Sterilization of intraoral and extraoral sites and draping has been installed. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used.
If the arch bar has been used it was inserted before the operation and being cut at the fracture line between the two segments.
The transoral or extra-oral approach is utilized to expose the fracture line separating the two segments.
Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate.
or even one 2.0 plate(champy) Then suturing the incision layers with vicryl 3/0. Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. The control group with no adjuvant intervention will stop at this point. The other intervention group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative.
Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
intervention group
Firstly the patient is generally anesthetized by the anesthesiologist. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used.
The transoral or extraoral approach is utilized to expose the fracture line separating the two segments.
Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate.
or 1 plate2.0 (champy) Then suturing the incision layers Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. This group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative.
Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site.
Radial Extracorporeal shockwave
a device used by physiotherapist to treat various musculoskeletal problems and it was here firstly used to accelerate the bone healing process after bone fracture
control group
Firstly the patient is generally anesthetized by the anesthesiologist. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used.
The transoral or extraoral approach is utilized to expose the fracture line separating the two segments.
Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate.
or 1 plate2.0 (champy) Then suturing the incision layers Postoperative evaluation with cone beam computed tomography (CBCT). The control group with no adjuvant intervention will stop at this point. Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radial Extracorporeal shockwave
a device used by physiotherapist to treat various musculoskeletal problems and it was here firstly used to accelerate the bone healing process after bone fracture
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
3- Patients free of systemic conditions that might affect or interfere with the healing process of bone segments or rather interfere with carrying out the surgical procedure (thyroid condition, rheumatoid arthritis, uncontrolled diabetes and osteoporosis).
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Khloud Ahmed Mohamed
Khloud Ahmed Mohamed Hussien
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo Univeristy
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Emad Saied, prof.
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Emad Saied, prof.
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Verma S, Chambers I. Update on patterns of mandibular fracture in Tasmania, Australia. Br J Oral Maxillofac Surg. 2015 Jan;53(1):74-7. doi: 10.1016/j.bjoms.2014.10.003. Epub 2014 Nov 1.
Sirimaharaj W, Pyungtanasup K. The epidemiology of mandibular fractures treated at Chiang Mai University Hospital: a review of 198 cases. J Med Assoc Thai. 2008 Jun;91(6):868-74.
Chocron Y, Azzi AJ, Davison P. Management of Pediatric Mandibular Fractures Using Resorbable Plates. J Craniofac Surg. 2019 Oct;30(7):2111-2114. doi: 10.1097/SCS.0000000000006002.
Fridrich KL, Pena-Velasco G, Olson RA. Changing trends with mandibular fractures: a review of 1,067 cases. J Oral Maxillofac Surg. 1992 Jun;50(6):586-9. doi: 10.1016/0278-2391(92)90438-6.
Lamphier J, Ziccardi V, Ruvo A, Janel M. Complications of mandibular fractures in an urban teaching center. J Oral Maxillofac Surg. 2003 Jul;61(7):745-9; discussion 749-50. doi: 10.1016/s0278-2391(03)00147-2.
Ellis E 3rd. Complications of rigid internal fixation for mandibular fractures. J Craniomaxillofac Trauma. 1996 Summer;2(2):32-9.
Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009 Nov;91(11):2589-97. doi: 10.2106/JBJS.H.00841.
Kaspar D, Neidlinger-Wilke C, Holbein O, Claes L, Ignatius A. Mitogens are increased in the systemic circulation during bone callus healing. J Orthop Res. 2003 Mar;21(2):320-5. doi: 10.1016/S0736-0266(02)00134-1.
Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
effect of ESWT on fractures
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.