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

NCT05801328 | Unknown DMC

• 1 other identifier: USM/JEPeM/22110704
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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)

Conditions

Maxillofacial Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Are there any differences between occlusally and apically bent groups in terms of Turesky-Gilmore-Glickman plaque score?

  Assessed on the fourth week.

• Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?

  Assessed on the second week

• Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?

  Assessed on the fourth week

Study Arms (2)

Occlusal ending of wires

EXPERIMENTAL

The wires will be bent occlusally for the interventional side

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

Apical ending of wires

NO INTERVENTION

The wires will be bent apically for the control side.

Interventions

Ending of the wires on Erich arch bar in the occlusal direction DEVICE

The wires of the Erich arch bar will be placed on the occlusal direction

Occlusal ending of wires

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• All pathologic fractures due to cysts, tumors, and cancers
• Medical conditions that contraindicate the usage of arch bars (Epilepsy, Asthmatics)

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (24)

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  PMID: 32798159 BACKGROUND

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• Kirk D, Whitney J, Shafer D, Song L. Tight Placement of Erich Arch Bar While Avoiding Wire Fatigue Failure. J Oral Maxillofac Surg. 2016 Mar;74(3):562-8. doi: 10.1016/j.joms.2015.10.008. Epub 2015 Oct 19.

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Related Links

• The Acute Management of Facial Fractures

MeSH Terms

Conditions

Maxillofacial Injuries

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Central Study Contacts

NG Kar Tsyeng, BDS

CONTACT

0165216351; kartsyeng86@Hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: this is a split mouth study. Participants teeth will be divided into left or right side and randomised into either control or intervention side.

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: April 6, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)