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NCT04518956 Clinical Trial

Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing

Mandibular Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04518956
Other study ID # Mandibular fracture healing
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 18, 2016
Est. completion date June 23, 2018

Study information
Verified date August 2020
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date June 23, 2018
Est. primary completion date February 7, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• inter maxillary fixation with shockwave therapy
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.
• Inter maxillary fixation and exposure to low intensity pulsed
Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.
• Inter maxillary fixation
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.

Locations
Country Name City State
Egypt Faculty of Dentistry Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Change in bone density using CT after 6 Weeks and 12 weeks
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