Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing

Study Overview
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Brief Summary
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compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures

Detailed Description
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The mandible is the commonest facial bone to fracture. Mandibular fractures represent more than 74% of all maxillofacial fractures. To compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures. A total of 21 patients; aged between 20-40 years, who have mandibular fracture were selected for this study from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. In this study all patients were subjected to closed reduction and intermaxillary fixation. This will be followed by shockwave therapy in seven patients as a study group and by low-intensity pulsed ultrasound in seven patients as study group. Seven patients will receive neither and will constitute the control group.

Official Title
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Comparative Study Between the Effect of Shockwave Therapy and Low-intensity Pulsed Ultrasound (LIPUS) on Bone Healing of Mandibular Fracture

Conditions
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Mandibular Fractures

Intervention / Treatment
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* Procedure: inter maxillary fixation with shockwave therapy
* Procedure: Inter maxillary fixation and exposure to low intensity pulsed
* Procedure: Inter maxillary fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria -Patients selected for this study will have fresh fracture mandible which is indicated for closed reduction. Exclusion Criteria -Patients having the following criteria will be excluded scars, burns, infection in the Skin in the relevant working area

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inter maxillary fixation and exposure to shockwave therapy<br> | Procedure: inter maxillary fixation with shockwave therapy<br>* Shockwave therapy device which give 1500-4000 pulses per session with or without anesthesia, and the treatment session takes approximately 5-10 minutes at the day after surgery.<br>|
| Experimental: Inter maxillary fixation and exposure to low intensity pulsed<br> | Procedure: Inter maxillary fixation and exposure to low intensity pulsed<br>* Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.<br>|
| Active Comparator: Inter maxillary fixation only<br> | Procedure: Inter maxillary fixation<br>* Closed reduction will be done. Intermaxillary fixation (IMF) will be secured after proper reduction of the fractured segments to assure proper occlusion using upper and lower arch bars or eyelet wires for six weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain scale | pain was scores using visual analouge scale from 0 to 10 0 means no pain 10 most severe pain | after 24 hours and 1 week | 
| Change in bone density | using CT | after 6 Weeks and 12 weeks |