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

NCT ID: NCT05801328

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-07-01

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)

Detailed Description

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Conditions

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Maxillofacial Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants are blinded

Study Groups

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Occlusal ending of wires

The wires will be bent occlusally for the interventional side

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Apical ending of wires

The wires will be bent apically for the control side.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type DEVICE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Ng Kar Tsyeng

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia

Site Status

Countries

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Malaysia

Central Contacts

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NG Kar Tsyeng, BDS

Role: CONTACT

0165216351

Facility Contacts

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NG Kar Tsyeng, BDS

Role: primary

0165216351

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Related Links

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Other Identifiers

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USM/JEPeM/22110704

Identifier Type: -

Identifier Source: org_study_id

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