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

Not Applicable

Not yet recruiting

• Conditions: Maxillofacial Injuries
• Interventions: Device: Ending of the wires on Erich arch bar in the occlusal direction

• Registration Number: NCT05801328
• Lead Sponsor: Universiti Sains Malaysia

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Study Start: 2023-04-01
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Occlusal ending of wires	Ending of the wires on Erich arch bar in the occlusal direction	The wires will be bent occlusally for the interventional side

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Are there any differences between occlusally and apically bent groups in terms of Turesky-Gilmore-Glickman plaque score?	Assessed on the fourth week.	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.
Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?	Assessed on the fourth week	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.

Trial Locations

Locations (1)

Universiti Sains Malaysia; 🇲🇾 Kota Bharu, Kelantan, Malaysia