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

Primary Purpose

Maxillofacial Injuries

Status

Not yet recruiting

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Maxillofacial Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

Universiti Sains Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Occlusal ending of wires

Apical ending of wires

Arm Description

The wires will be bent occlusally for the interventional side

The wires will be bent apically for the control side.

Outcomes

Primary Outcome Measures

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'.

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'.

Secondary Outcome Measures

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

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?

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.

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

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.

Full Information

NCT ID

NCT05801328

First Posted

March 12, 2023

Last Updated

March 23, 2023

Sponsor

Universiti Sains Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT05801328

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2023 (Anticipated)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Maxillofacial Injuries

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Masking Description

Participants are blinded

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Occlusal ending of wires

Arm Type

Experimental

Arm Description

The wires will be bent occlusally for the interventional side

Arm Title

Apical ending of wires

Arm Type

No Intervention

Arm Description

The wires will be bent apically for the control side.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?

Description

Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'.

Time Frame

Assessed on the second week

Title

Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?

Description

Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'.

Time Frame

Assessed on the fourth week

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Assessed on the fourth week.

Title

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

Description

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.

Time Frame

Assessed on the second week

Title

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

Description

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.

Time Frame

Assessed on the fourth week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

NG Kar Tsyeng, BDS

Phone

0165216351

kartsyeng86@Hotmail.com

Facility Information:

Facility Name

Universiti Sains Malaysia

City

Kota Bharu

State/Province

Kelantan

ZIP/Postal Code

16150

Country

Malaysia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NG Kar Tsyeng, BDS

Phone

0165216351

kartsyeng86@hotmail.com

First Name & Middle Initial & Last Name & Degree

NG Kar Tsyeng, BDS

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

https://www.infona.pl/resource/bwmeta1.element.springer-doi-10_1007-S40719-016-0040-4

Description

The Acute Management of Facial Fractures

URL

https://www.karger.com/Article/Abstract/77756

Description

Dental plaque as a microbial biofilm.

Learn more about this trial

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

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