Skip to main content
OpenTrials
Completed

NCT Number: NCT04518956

Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mandibular Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, 21526, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inter maxillary fixation with shockwave therapy

Procedure

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

Procedure

Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.

Inter maxillary fixation

Procedure

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 outcomes

  1. Change in pain scale

    Time frame: after 24 hours and 1 week

    pain was scores using visual analouge scale from 0 to 10 0 means no pain 10 most severe pain

  2. Change in bone density

    Time frame: after 6 Weeks and 12 weeks

    using CT

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2020
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.