Fracture Gap After Herbert Screw Insertion by 3d Stents Vs Titanium Plate(Minimally Displaced Mandibular Angle Fracture)
Primary Purpose
Minimally Displaced Mandibular Angle Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D stent in Herbert screw insertion vs titanium plate
Sponsored by
About this trial
This is an interventional treatment trial for Minimally Displaced Mandibular Angle Fracture
Eligibility Criteria
Inclusion Criteria:
patient age between 20 to 45
- Patients with minimally displaced angular fracture
- Patients free from any systemic disease that delay bone healing
- Patients free from any metabolic bone disease delaying the healing
- Patients who approved to be included in the trial and signed the informed consent.
Exclusion Criteria:
.Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing.(Hopewell, 2003)
- Patients who refused to be included in the trial
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
intervention group
control group
Arm Description
3D stent in Herbert screw insertion vs titanium plate
titanium plate
Outcomes
Primary Outcome Measures
inertfragmentary gap
will be measured using the panoramic xray film on the panoramic radiograph a line was drawn along the fracture and it was divided into 3 equal parts in mm. Perpendicular lines were projected onto the fracture line for reproducible measure points. Measurements of the fracture gap were conducted on these 4 defined points
Secondary Outcome Measures
pain relief
measuring the pain using visual analogue scale (scale fom 0 -10) the patient is asked to pick a number from 0(no pain) till 10(unbearable pain)
nerve sensitivity
nerve sensitivity through neurosensory examination score (score from 1-5) 1means absent to 5 which is intense
maximum incisal opening
using a caliper the measuring unit is in millimeters more opening means better result
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03692260
Brief Title
Fracture Gap After Herbert Screw Insertion by 3d Stents Vs Titanium Plate(Minimally Displaced Mandibular Angle Fracture)
Official Title
Interfragmentary Gap Following Cannulated Headless Herbert Screw Insertion Using Customized 3-D Surgical Templates Versus Titanium Plate In Reduction & Fixation of Unilateral Minimally Displaced Mandibular Angle Fracture. RCT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2018 (Anticipated)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
interfragmentary gap measurement using Herbert cannulated headless screw using a 3D surgical customized template versus titanuim plate
Detailed Description
Intervention for each group
Diagnosis
for group I and II According to inclusion and exclusion criteria, patients are selected after a comprehensive clinical and radiographic examination and understanding of participant s chief complains.
Inspection for the soft tissue laceration, edema, ecchymosis, hemorrhage, cerebrospinal fluid leakage, gingival lacerations, mandible contour deformity, facial asymmetry and the other facial bones bilateral palpation starting from the condylar region descending towards the posterior border of the mandible to look for any tenderness, step deformities or crepitus. Examination of the integrity of the neurosensory and motor function of the injured area.
Checking the amount of occlusal discrepancy with complete and comprehensive examination of the dentition.
Mandibular movements will also be checked with emphasis on maximal Interincisal opening and midline shift in opening and closing positions.
Surgical planning Group I :participants will be treated using Herbert headless cannulated screw(Zimmer® Herbert™ ,united states of America )Cannulated Bone Screw) using 3d template GroupII :patients are treated using titanium plates (4 or 6 holes according to each case) orthomed ,6th of October,Egypt)
Intra-operative procedures:
-All of the participants will be treated under general anaesthesia using nasal intubation
The occlusion was secured with temporary IMF and the fracture line was exposed and manually reduced.
Infiltration Local anesthesia with vasoconstrictor will be injected intraorally at the incision site for hemostatic purposes and pain control.
Scrubbing and draping of the patient will be carried out in a standard fashion.
An intraoral incision to expose the fracture line. Dissection and reflection to reach the bone For the intervention group planning using the ct software to produce a guiding template of the mandible in the normal position for the insertion of the Herbert screw.
Reduction of the fracture -Fixation of the fractured segments through Herbert screw using the 3D template fabricated by Plastycad 3diemme Italy(group I), or by using titanium the plate (groupII)
-Double checking and verification of the occlusion before wound closure.
-Wounds are debrided and sutured.
Postoperative
- Cold application at the site of surgery in the form of ice packs 10 minutes every hour in the first 6 hours.
-Broad spectrum antibiotic therapy in the form of Unasyn 1500 mg vials was given as an IV shot to the patient every 12 hours for 5 days to reduce the risk of infection. (Unasyn®: manufactured by Pfizer, Egypt S.A.E Cairo, A.R.E)
Non-steroidal anti-inflammatory drug will be administered in the form of Voltaren 75mg ampoule 3 times daily for 3 days to relief the pain. (Voltaren®: NOVARTIS PHARMA S.A.E. Cairo, under license from: Novartis Pharma AG, Basle, Switzerland.)
Follow up & Evaluation
Clinical follow up parameters:
For group I and group II - Dehiscence of the soft tissue and hardware exposure. - Pain over visual analogue scale over first 72 hours.
Maximum incisal opening (MIO)
Stability of the fractured segments.
Radiographic follow up parameters:
- Bone union/nonunion and malunion (OPG).
Bone to bone contact via mandible form & border contour (OPG) (3diagnosys 3diemme Italy version 4.2 Any participant that can cause an adverse effect to the intervention/control group will be excluded
the patients will receive their panoramic x-ray at the accurate indicated intervals.
The the MIO will be tested for all patients under the same chair postion using the same caliper, the visual analogue scale to measure the pain will be explained to the patient to prevent any misunderstanding and for the sensory function the patients will be asked to close their eyes before we start to prevent any misleading data as he will not be able to see area we are checking. Those Strategies will be used to improve adherence to intervention protocols.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimally Displaced Mandibular Angle Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
3D stent in Herbert screw insertion vs titanium plate
Arm Title
control group
Arm Type
No Intervention
Arm Description
titanium plate
Intervention Type
Procedure
Intervention Name(s)
3D stent in Herbert screw insertion vs titanium plate
Intervention Description
benefit of 3d template in fracture gap
Primary Outcome Measure Information:
Title
inertfragmentary gap
Description
will be measured using the panoramic xray film on the panoramic radiograph a line was drawn along the fracture and it was divided into 3 equal parts in mm. Perpendicular lines were projected onto the fracture line for reproducible measure points. Measurements of the fracture gap were conducted on these 4 defined points
Time Frame
3 months as after that time bone remodeling will happen and measuring the interfragmentary gap will be inaccurate
Secondary Outcome Measure Information:
Title
pain relief
Description
measuring the pain using visual analogue scale (scale fom 0 -10) the patient is asked to pick a number from 0(no pain) till 10(unbearable pain)
Time Frame
3 months
Title
nerve sensitivity
Description
nerve sensitivity through neurosensory examination score (score from 1-5) 1means absent to 5 which is intense
Time Frame
3 months
Title
maximum incisal opening
Description
using a caliper the measuring unit is in millimeters more opening means better result
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patient age between 20 to 45
Patients with minimally displaced angular fracture
Patients free from any systemic disease that delay bone healing
Patients free from any metabolic bone disease delaying the healing
Patients who approved to be included in the trial and signed the informed consent.
Exclusion Criteria:
.Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing.(Hopewell, 2003)
Patients who refused to be included in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nevine AE Fathy mohammed elfath omar, a lecturer
Phone
01011180702
Ext
202
Email
vina.alex@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
omnia i sultan, lecturer
Phone
01001741757
Ext
202
Email
omom1278@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hussein h Abd elrahman, a professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results are published as partial fulfillment of the requirements for Phd degree in Oral and maxillofacial surgery by the investigator by cairo university
Learn more about this trial
Fracture Gap After Herbert Screw Insertion by 3d Stents Vs Titanium Plate(Minimally Displaced Mandibular Angle Fracture)
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