Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture

Mandible Fracture Clinical Trial

Official title:

Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03747666
• Other study ID #: 30101980
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: November 2020

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

Description:

Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.

• Fractures amenable to treatment using intra oral approach.

Exclusion Criteria:

• Medically compromised patients who are unfit for the procedure under general anesthesia.

• Patients with comminuted fractures.

• Patients with history of occlusion disturbances or skeletal malocclusion.

• Patients with insufficient dentition to reproduce occlusion.

Related Conditions & MeSH terms

• Fractures, Bone
• Mandible Fracture
• Mandibular Fractures

Intervention

Procedure:
• 2.0 single locking miniplates
The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biting force	Biting force will be measured using occlusal biting force meter (Higher biting force record is better)	6 months
Secondary	Stability of fractured segments	Bi-manual manipulation (Binary Yes/No)	6 weeks
Secondary	Pain intensity	Visual analog scale (0-10) 0=No pain & 10=Severe pain	10 days
Secondary	Occlusion	Clinical examination (Intact/Deranged)	6 months
Secondary	Infection	Clinical examination (Present/Absent)	6 months
Secondary	Hardware failure	Clinical examination (Present/Absent)	6 months
Secondary	Paraesthesia	Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation & 10= Normal sensation	6 months
Secondary	Wound dehiscence	Clinical examination (Present/Absent)	6 months