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Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation

Primary Purpose

Mandibular Fractures

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
screw retained arch bar
conventional Erich's Arch Bar
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Fractures

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patients age ranges from 18 to 50 years.
  2. Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.
  3. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.

Exclusion Criteria:

  • 1) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.

Sites / Locations

  • Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional Erich's arch bar

Screw Retained Arch Bar

Arm Description

• Patients will receive conventional Erich's arch bar

patients will receive modified screw retained arch bar.

Outcomes

Primary Outcome Measures

duration of surgical procedure in minutes
Duration between the starting of fixation and complete fixation of fracture
maxillomandibular fixation stability in nominal scale(stable-unstable)
stability after fixation
maxillomandibular fixation stability in nominal scale(stable-unstable)
stability after fixation
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.

Secondary Outcome Measures

number of iatrogenic injuries
iatrogenic injuries to teeth and gingiva
number of needle and wire stick injuries
injuries to the surgeon and the assistants.
pain assessment using numeric rating scale (NRS)
participants rated their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Full Information

First Posted
May 29, 2022
Last Updated
April 6, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05401994
Brief Title
Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
Official Title
Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation
Detailed Description
2) Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional Erich's arch bar
Arm Type
Active Comparator
Arm Description
• Patients will receive conventional Erich's arch bar
Arm Title
Screw Retained Arch Bar
Arm Type
Experimental
Arm Description
patients will receive modified screw retained arch bar.
Intervention Type
Procedure
Intervention Name(s)
screw retained arch bar
Intervention Description
maxillomandibular fixation with bone screwed arch bar
Intervention Type
Procedure
Intervention Name(s)
conventional Erich's Arch Bar
Intervention Description
maxillomandibular fixation with conventional arch bar fixed to the teeth
Primary Outcome Measure Information:
Title
duration of surgical procedure in minutes
Description
Duration between the starting of fixation and complete fixation of fracture
Time Frame
intraoperative
Title
maxillomandibular fixation stability in nominal scale(stable-unstable)
Description
stability after fixation
Time Frame
immediately postoperative
Title
maxillomandibular fixation stability in nominal scale(stable-unstable)
Description
stability after fixation
Time Frame
4-6 weeks
Title
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
Description
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
Time Frame
immediately postoperative
Title
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
Description
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
number of iatrogenic injuries
Description
iatrogenic injuries to teeth and gingiva
Time Frame
intraoperative
Title
number of needle and wire stick injuries
Description
injuries to the surgeon and the assistants.
Time Frame
intraoperative
Title
pain assessment using numeric rating scale (NRS)
Description
participants rated their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time Frame
immediately postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients age ranges from 18 to 50 years. Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures. Exclusion Criteria: 1) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.
Facility Information:
Facility Name
Mansoura university
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation

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