Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing

Not Applicable

Completed

• Conditions: Mandibular Fractures
• Interventions: Procedure: Inter maxillary fixation and exposure to low intensity pulsed; Procedure: Inter maxillary fixation; Procedure: inter maxillary fixation with shockwave therapy

• Registration Number: NCT04518956
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Study Timeline

• Study Start: 2016-12-18
• Primary Completion: 2018-02-07
• Study Completion: 2018-06-23
• Status Verified: 2020-08
• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-16
• Last Update Submitted: 2020-08-16
• Study First Posted: 2020-08-19
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inter maxillary fixation and exposure to low intensity pulsed	Inter maxillary fixation and exposure to low intensity pulsed	-
Inter maxillary fixation only	Inter maxillary fixation	-
Inter maxillary fixation and exposure to shockwave therapy	inter maxillary fixation with shockwave therapy	-

Primary Outcome Measures

Name	Time	Method
Change in pain scale	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
Change in bone density	after 6 Weeks and 12 weeks	using CT

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Egypt