Back to resultsShockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing
Primary Purpose
Mandibular Fractures
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
inter maxillary fixation with shockwave therapy
Inter maxillary fixation and exposure to low intensity pulsed
Inter maxillary fixation
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Fractures
Eligibility Criteria
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
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Inter maxillary fixation and exposure to shockwave therapy
Inter maxillary fixation and exposure to low intensity pulsed
Inter maxillary fixation only
Arm Description
Outcomes
Primary Outcome Measures
Change in pain scale
pain was scores using visual analouge scale from 0 to 10 0 means no pain 10 most severe pain
Change in bone density
using CT
Secondary Outcome Measures
Full Information
NCT ID
NCT04518956
First Posted
August 16, 2020
Last Updated
August 16, 2020
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT04518956
Brief Title
Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing
Official Title
Comparative Study Between the Effect of Shockwave Therapy and Low-intensity Pulsed Ultrasound (LIPUS) on Bone Healing of Mandibular Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 18, 2016 (Actual)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
June 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inter maxillary fixation and exposure to shockwave therapy
Arm Type
Experimental
Arm Title
Inter maxillary fixation and exposure to low intensity pulsed
Arm Type
Experimental
Arm Title
Inter maxillary fixation only
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
inter maxillary fixation with shockwave therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Inter maxillary fixation and exposure to low intensity pulsed
Intervention Description
Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.
Intervention Type
Procedure
Intervention Name(s)
Inter maxillary fixation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain scale
Description
pain was scores using visual analouge scale from 0 to 10 0 means no pain 10 most severe pain
Time Frame
after 24 hours and 1 week
Title
Change in bone density
Description
using CT
Time Frame
after 6 Weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Dentistry
City
Alexandria
ZIP/Postal Code
21526
Country
Egypt
12. IPD Sharing Statement
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Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing
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