Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing
Comparative Study Between the Effect of Shockwave Therapy and Low-intensity Pulsed Ultrasound (LIPUS) on Bone Healing of Mandibular Fracture
1 other identifier
interventional
21
1 country
1
Brief Summary
compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2018
CompletedFirst Submitted
Initial submission to the registry
August 16, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedAugust 19, 2020
August 1, 2020
1.1 years
August 16, 2020
August 16, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Inter maxillary fixation and exposure to shockwave therapy
EXPERIMENTALInter maxillary fixation and exposure to low intensity pulsed
EXPERIMENTALInter maxillary fixation only
ACTIVE COMPARATORInterventions
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.
Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.
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.
Eligibility Criteria
You may not qualify if:
- Patients having the following criteria will be excluded scars, burns, infection in the Skin in the relevant working area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry
Alexandria, 21526, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
August 16, 2020
First Posted
August 19, 2020
Study Start
December 18, 2016
Primary Completion
February 7, 2018
Study Completion
June 23, 2018
Last Updated
August 19, 2020
Record last verified: 2020-08