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

A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation

Study Overview

• Status: Completed
• Conditions: Mandibular Fractures
• Intervention / Treatment: Procedure: conventional Erich's Arch Bar; Procedure: screw retained arch bar

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional Erich's arch bar; • Patients will receive conventional Erich's arch bar	Procedure: conventional Erich's Arch Bar; maxillomandibular fixation with conventional arch bar fixed to the teeth
Experimental: Screw Retained Arch Bar; patients will receive modified screw retained arch bar.	Procedure: screw retained arch bar; maxillomandibular fixation with bone screwed arch bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of surgical procedure in minutes	Duration between the starting of fixation and complete fixation of fracture	intraoperative
maxillomandibular fixation stability in nominal scale(stable-unstable)	stability after fixation	immediately postoperative
maxillomandibular fixation stability in nominal scale(stable-unstable)	stability after fixation	4-6 weeks
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.	immediately postoperative
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.	4-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of iatrogenic injuries	iatrogenic injuries to teeth and gingiva	intraoperative
number of needle and wire stick injuries	injuries to the surgeon and the assistants.	intraoperative
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").	immediately postoperative

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: A03080921

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