The Impact of ESWT on Healing of Fractured Mandible

The Impact of Using Extracorporeal Radial Shock Wave Therapy as an Adjuvant Therapy vs Conventional Open Reduction and Internal Fixation With No Adjuvant Therapy on Bone Healing for Patients With Mandibular Parasymphyseal, Body and Angle Fractures

studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws.

Study Overview

• Status: Recruiting
• Conditions: Fractured Mandible Due to Trauma
• Intervention / Treatment: Device: Radial Extracorporeal shockwave

Detailed Description

Firstly the patient heads to the operating room being placed in a supine position, generally anesthetized by the anesthesiologist.

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: khloud nasr el-din, GP.; Phone Number: 01014919174; Email: khloud.ahmed@dentistry.cu.edu.eg
• Study Contact Backup: Name: Emad Saied, prof.

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo Univeristy
    • Contact: khloud nasr eldin, GP; Phone Number: 01014919174; Email: khloud.ahmed@dentistry.cu.edu.eg
    • Contact: Emad Saied, prof.; Phone Number: 01222117986

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

1. Patients with age ranges from 18-75 years old.
2. Patients with fresh mandibular fractures (from zero hour till four or five days).
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).

Description

Inclusion Criteria:

1 - Patients with age ranges from 18-75 years old. 2- Patients with fresh mandibular fractures (from zero hour till four or five days).

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:

1 - Patients out of the specified range group 2- Patients who went previous operations with infection or malunion. 3- Patients with thyroid condition which affects the serum calcium level. 4- Patients with systemic conditions that might affect the bone health (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes). 5- Patients with heart peacemakers.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone healing (denisty of bone)	radiographically we will analyze the bone denisty at the fracture site	first and fourth month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain sensation	depending on the patient using VAS	immediately after the intervention and 3 days after

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: J Bone Joint Surg Am. 2010 May;92(5):1241.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: effect of ESWT on fractures

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No