Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation

Not Applicable

Completed

• Conditions: Mandibular Fractures
• Interventions: Procedure: conventional Erich's Arch Bar; Procedure: screw retained arch bar

• Registration Number: NCT05401994
• Lead Sponsor: Mansoura University

Brief Summary

A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation

Detailed Description

2) Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-29
• Study First Submitted QC: 2022-05-29
• Study First Posted: 2022-06-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. The patients age ranges from 18 to 50 years.
2. Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.
3. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.

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Exclusion Criteria

• 1. Edentulous ridge fracture. 2) Patients having primary and mixed dentition.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional Erich's arch bar	conventional Erich's Arch Bar	• Patients will receive conventional Erich's arch bar
Screw Retained Arch Bar	screw retained arch bar	patients will receive modified screw retained arch bar.

Primary Outcome Measures

Name	Time	Method
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)	4-6 weeks	the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
duration of surgical procedure in minutes	intraoperative	Duration between the starting of fixation and complete fixation of fracture
maxillomandibular fixation stability in nominal scale(stable-unstable)	4-6 weeks	stability after fixation

Secondary Outcome Measures

Name	Time	Method
number of iatrogenic injuries	intraoperative	iatrogenic injuries to teeth and gingiva
pain assessment using numeric rating scale (NRS)	immediately postoperative	participants rated their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
number of needle and wire stick injuries	intraoperative	injuries to the surgeon and the assistants.

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Egypt