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

March 23, 2023 updated by: Ng Kar Tsyeng, Universiti Sains Malaysia

Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar: A Prospective Split-mouth Randomized Clinical Trial

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia
        • Contact:
        • Principal Investigator:
          • NG Kar Tsyeng, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occlusal ending of wires
The wires will be bent occlusally for the interventional side
Device: 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
No Intervention: Apical ending of wires
The wires will be bent apically for the control side.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Are there any differences between occlusally and apically bent groups in terms of Turesky-Gilmore-Glickman plaque score?
Time Frame: 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.
Assessed on the fourth week.
Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?
Time Frame: Assessed on the second week

The operator will assess all circumferential wires on the second week. Any loose wires will be scored as '1' and '0' if the wires are firm.

The loose wires will be retightened.
Assessed on the second week
Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?
Time Frame: 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.
Assessed on the fourth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/22110704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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