The Impact of ESWT on Healing of Fractured Mandible

NCT06363188 | Recruiting DMC

• 1 other identifier: effect of ESWT on fractures
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fractured Mandible Due to Trauma

Outcome Measures

Primary Outcomes (1)

• bone healing (denisty of bone)

  radiographically we will analyze the bone denisty at the fracture site

  first and fourth month

Secondary Outcomes (1)

• pain sensation

  immediately after the intervention and 3 days after

Study Arms (2)

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

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.

Interventions

Radial Extracorporeal shockwave DEVICE

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

intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Univeristy

Cairo, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 25453253 BACKGROUND

• 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.

  PMID: 18697387 BACKGROUND

• 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.

  PMID: 31568159 BACKGROUND

• 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.

  PMID: 1593318 BACKGROUND

• 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.

  PMID: 12856243 BACKGROUND

• Ellis E 3rd. Complications of rigid internal fixation for mandibular fractures. J Craniomaxillofac Trauma. 1996 Summer;2(2):32-9.

  PMID: 11951481 BACKGROUND

• 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.

  PMID: 19884432 BACKGROUND

• 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.

  PMID: 12568965 BACKGROUND

• 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.

  PMID: 28850536 BACKGROUND

Central Study Contacts

khloud nasr el-din, GP.

CONTACT

01014919174; khloud.ahmed@dentistry.cu.edu.eg

Emad Saied, prof.

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Khloud Ahmed Mohamed Hussien

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 30, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

EG (1)