Clinical trial NCT05801328: Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar
Official title: Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar: A Prospective Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillofacial Injuries
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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)


Eligibility criteria: 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)

Primary outcomes:
measure: Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?
timeFrame: Assessed on the second week
measure: Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?
timeFrame: Assessed on the fourth week
Secondary outcomes:
measure: Are there any differences between occlusally and apically bent groups in terms of Turesky-Gilmore-Glickman plaque score?
timeFrame: Assessed on the fourth week.
measure: Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?
timeFrame: Assessed on the second week
measure: Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?
timeFrame: Assessed on the fourth week
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
Study officials:
References:
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