Back to resultsComparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
Primary Purpose
Mandibular Fractures
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lag Screws
double Y-shaped plates
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Fractures
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders
- with age ranging from 25 to 45 years,
- suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)
Exclusion Criteria:
- old fractures,
- infected fractures
- comminuted fractures
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lag Screws
Double Y-shaped plates
Arm Description
Group 1: underwent open reduction and internal fixation using two lag screws.
Group 2: underwent open reduction and internal fixation using double Y-shaped plates.
Outcomes
Primary Outcome Measures
progress of fracture healing in the postoperative period
Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density
Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04396054
Brief Title
Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
Official Title
Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lydia Nabil
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
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.
Detailed Description
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.
Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.
Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.
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
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lag Screws
Arm Type
Active Comparator
Arm Description
Group 1: underwent open reduction and internal fixation using two lag screws.
Arm Title
Double Y-shaped plates
Arm Type
Active Comparator
Arm Description
Group 2: underwent open reduction and internal fixation using double Y-shaped plates.
Intervention Type
Device
Intervention Name(s)
Lag Screws
Intervention Description
Method of internal fixation
Intervention Type
Device
Intervention Name(s)
double Y-shaped plates
Intervention Description
Method of internal fixation
Primary Outcome Measure Information:
Title
progress of fracture healing in the postoperative period
Description
Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density
Time Frame
after 6 months
Title
Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
Description
Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both genders
with age ranging from 25 to 45 years,
suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)
Exclusion Criteria:
old fractures,
infected fractures
comminuted fractures
Facility Information:
Facility Name
Faculty of Dentistry
City
Alexandria
ZIP/Postal Code
21411
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
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