Mandibular Fracture Reduction Using Bone Reduction Forceps

Mandibular Fractures Clinical Trial

Official title:

Evaluation of Bone Reduction Forceps in Reducing Mandibular Fracture

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04443998
• Other study ID #: Mandibular fracture reduction
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments.

Description:

The aim of this study is to evaluate clinically and radiographically the effect of using bone reduction forceps in the reduction of isolated mandibular fractures.

10 patients complaining of isolated mandibular fractures in need of open reduction and internal fixation underwent reduction using bone reduction forceps.

The patients followed up clinically after 1 and 2 weeks, 1, 3, and 6 months postoperatively. Radiographic evaluation will be performed by computed tomography (CT) preoperatively, and cone-beam computed tomography (CBCT) will be done after 3 and 6 months

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 1, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion criteria

• Adult patients aged from 20 to 45 years will be included.

• Patients suffered from recent and uninfected.

• Patients with isolated mandibular fractures.

Exclusion criteria

• Medically compromised patients that will be not fit for surgery.

• Edentulous patients.

• Non-displaced

• Comminuted fracture with bone loss

• Old fracture, more than 3 weeks

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Device:
• Bone reducion forceps
Repositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

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 radiodensitometric measurements	cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture	at 3rd, 6th months
Primary	change in maximal mouth opening	maximal interincisal opening between maxillary and mandibular central incisors.	1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Primary	change in occlusion	Any occlusal disturbance including open bite or improper tooth contact will be recorded	1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Primary	change in pain level	Pain: will be measured on Visual Analogue Scale (VAS). The patients will be asked to rate their postoperative pain on a 4-point scale (0= none, 1= slight, 2= moderate, 3- severe)	1 week, 2 weeks, 1 month, 6 weeks, and 3 months