Clinical trial NCT06363188: The Impact of ESWT on Healing of Fractured Mandible
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fractured Mandible Due to Trauma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: bone healing (denisty of bone)
timeFrame: first and fourth month
Secondary outcomes:
measure: pain sensation
timeFrame: immediately after the intervention and 3 days after
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo Univeristy
Study officials:
References:
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