Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar

Study Overview
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Brief Summary
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Patients with jaw fractures requires placement of Erich arch bar for immobilization of the fractured jaw. However, the usage of Erich arch bar is associated with an increased in the incidence of mucosal trauma and plaque accumulation. Conventionally, the ends of the wires has always been placed apical to the teeth. This study aims to determine if a change in the placement of the wire by directing it to the occlusal direction will reduce the incidence of mucosal trauma, plaque accumulation and if the stability of the Erich arch bar will be affected by this intervention. The patients' teeth will be divided into left and right side and randomized into control side (wires end apically) and interventional side (wires end occlusally)

Official Title
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Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar: A Prospective Split-mouth Randomized Clinical Trial

Conditions
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Maxillofacial Injuries

Intervention / Treatment
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* Device: Ending of the wires on Erich arch bar in the occlusal direction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years - 60 years old. Full Glasgow coma scale. Facial fractures requiring Erich arch bar for 4 weeks duration No functional deficit that will prevent tooth brushing. Exclusion Criteria: All pathologic fractures due to cysts, tumors, and cancers Medical conditions that contraindicate the usage of arch bars (Epilepsy, Asthmatics)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: this is a split mouth study. Participants teeth will be divided into left or right side and randomised into either control or intervention side.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occlusal ending of wires<br>The wires will be bent occlusally for the interventional side | Device: Ending of the wires on Erich arch bar in the occlusal direction<br>* The wires of the Erich arch bar will be placed on the occlusal direction<br>|
| No Intervention: Apical ending of wires<br>The wires will be bent apically for the control side. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Are there any differences between occlusally and apically bent groups in terms of mucosal trauma? | Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'. | Assessed on the second week | 
| Are there any differences between occlusally and apically bent groups in terms of mucosal trauma? | Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'. | Assessed on the fourth week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Are there any differences between occlusally and apically bent groups in terms of Turesky-Gilmore-Glickman plaque score? | Assessment of the plaque score using Turesky-Gilmore-Glickman plaque score. There are 6 scores for this plaque index, ranging from score '0' to '5'. Score '0' means that no plaque is seen, '1' when separate flecks of plaque at the cervical margin of the tooth, '2' when a thin continuous band of plaque at the cervical margin of the tooth, '3' when a band of plaque thicker than 1mm but less than 1/3rd of the tooth surface. '4' when plaque covers at least 1/3rd but less than 2/3rd of the crown and '5' when plaque is covering 2/3rd or more of the crown of the tooth. The teeth involved in the scoring in this study are buccal surfaces of the 1st molars, premolars, canines and incisors. Since the lingual/palatal surfaces are not accessible as the teeth are wired up, it will not be assessed Score '0' is the best while score of '5' is the worst. This assessment is done on the fourth week after removal of the arch bar and staining of the teeth with a disclosing solution. | Assessed on the fourth week. | 
| Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar? | The operator will assess all circumferential wires on the second week. Any loose wires will be scored as '1' and '0' if the wires are firm. The loose wires will be retightened. | Assessed on the second week | 
| Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar? | The operator will assess all circumferential wires on the fourth week. Any loose wires will be scored as '1' and '0' if the wires are firm. The loose wires will be retightened. | Assessed on the fourth week |