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

Universiti Sains Malaysia

Status: Not yet enrolling

Conditions: Maxillofacial Injuries

Treatments: Device: Ending of the wires on Erich arch bar in the occlusal direction

Study type: Interventional

Funder types: Other

Identifiers

NCT05801328

USM/JEPeM/22110704

Details and patient eligibility

About

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)

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

24 participants in 2 patient groups

Occlusal ending of wires

Experimental group

Description:

The wires will be bent occlusally for the interventional side

Treatment:

Device: Ending of the wires on Erich arch bar in the occlusal direction

Apical ending of wires

No Intervention group

Description:

The wires will be bent apically for the control side.