Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
1 other identifier
interventional
20
1 country
1
Brief Summary
A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 29, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedApril 10, 2023
May 1, 2022
1.4 years
May 29, 2022
April 6, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
number of iatrogenic injuries
intraoperative
number of needle and wire stick injuries
intraoperative
pain assessment using numeric rating scale (NRS)
immediately postoperative
Study Arms (2)
conventional Erich's arch bar
ACTIVE COMPARATOR• Patients will receive conventional Erich's arch bar
Screw Retained Arch Bar
EXPERIMENTALpatients will receive modified screw retained arch bar.
Interventions
maxillomandibular fixation with bone screwed arch bar
maxillomandibular fixation with conventional arch bar fixed to the teeth
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university
Al Mansurah, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2022
First Posted
June 2, 2022
Study Start
September 1, 2021
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
April 10, 2023
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share