Mandibular Fracture Reduction Using Bone Reduction Forceps

Not Applicable

• Conditions: Mandibular Fractures
• Interventions: Device: Bone reducion forceps

• Registration Number: NCT04443998
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2019-10-16
• Status Verified: 2020-06
• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-20
• Last Update Submitted: 2020-06-20
• Study First Posted: 2020-06-23
• Last Update Posted: 2020-06-23
• Primary Completion: 2020-08-18
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone reduction forceps	Bone reducion forceps	-

Primary Outcome Measures

Name	Time	Method
Change in radiodensitometric measurements	at 3rd, 6th months	cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture
change in maximal mouth opening	1 week, 2 weeks, 1 month, 6 weeks, and 3 months	maximal interincisal opening between maxillary and mandibular central incisors.
change in pain level	1 week, 2 weeks, 1 month, 6 weeks, and 3 months	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)
change in occlusion	1 week, 2 weeks, 1 month, 6 weeks, and 3 months	Any occlusal disturbance including open bite or improper tooth contact will be recorded

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt