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

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

Detailed Description
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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.

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

Conditions
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Mandibular Fractures

Intervention / Treatment
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* Procedure: screw retained arch bar
* Procedure: conventional Erich's Arch Bar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients age ranges from 18 to 50 years. 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. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures. Exclusion Criteria: 1) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional Erich's arch bar<br>• Patients will receive conventional Erich's arch bar | Procedure: conventional Erich's Arch Bar<br>* maxillomandibular fixation with conventional arch bar fixed to the teeth<br>|
| Experimental: Screw Retained Arch Bar<br>patients will receive modified screw retained arch bar. | Procedure: screw retained arch bar<br>* maxillomandibular fixation with bone screwed arch bar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of surgical procedure in minutes | Duration between the starting of fixation and complete fixation of fracture | intraoperative | 
| maxillomandibular fixation stability in nominal scale(stable-unstable) | stability after fixation | immediately postoperative | 
| maxillomandibular fixation stability in nominal scale(stable-unstable) | stability after fixation | 4-6 weeks | 
| oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S) | 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. | immediately postoperative | 
| oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S) | 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. | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of iatrogenic injuries | iatrogenic injuries to teeth and gingiva | intraoperative | 
| number of needle and wire stick injuries | injuries to the surgeon and the assistants. | intraoperative | 
| pain assessment using numeric rating scale (NRS) | 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). | immediately postoperative |