Minimally Displaced Mandibular Angle FractureNCT03692260
Fracture Gap After Herbert Screw Insertion by 3d Stents Vs Titanium Plate(Minimally Displaced Mandibular Angle Fracture)
A study testing 3D stent in Herbert screw insertion vs titanium plate in people with Minimally Displaced Mandibular Angle Fracture, run by Cairo University.
Trial summary
interfragmentary gap measurement using Herbert cannulated headless screw using a 3D surgical customized template versus titanuim plate Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Minimally Displaced Mandibular Angle Fracture
- What is being tested?
- 3D stent in Herbert screw insertion vs titanium plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- .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
Trial locations and contacts
No sites are listed yet.
About this study
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
interfragmentary gap measurement using Herbert cannulated headless screw using a 3D surgical customized template versus titanuim plate
Read the 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.
- Being tested
- 3D stent in Herbert screw insertion vs titanium plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D stent in Herbert screw insertion vs titanium plateProcedure or surgery
benefit of 3d template in fracture gap
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | 3D stent in Herbert screw insertion vs titanium plate Receives: Procedure: 3D stent in Herbert screw insertion vs titanium plate |
| control group | No intervention | titanium plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months as after that time bone remodeling will happen and measuring the interfragmentary gap will be inaccurate
Secondary outcomes (3)
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)
Measured: 3 months
nerve sensitivity
nerve sensitivity through neurosensory examination score (score from 1-5) 1means absent to 5 which is intense
Measured: 3 months
maximum incisal opening
using a caliper the measuring unit is in millimeters more opening means better result
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start25 Oct 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Displaced Mandibular Angle FractureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevine Alaa Eldine, Cairo University
- Investigators
- Hussein h Abd elrahman, a professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692260
- Sponsor's protocol ID
- CEBD-CU-2018-09-29
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results are published as partial fulfillment of the requirements for Phd degree in Oral and maxillofacial surgery by the investigator by cairo university
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03692260
- Acronym / sponsor ID
- CEBD-CU-2018-09-29
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Oct 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Procedure: 3D stent in Herbert screw insertion vs titanium plate3D stent in Herbert screw insertion vs titanium plate |
| control group | No intervention | –titanium plate |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patient age between 20 to 45
Key exclusion criteria (2 listed)
- .Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing.(Hopewell, 2003)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D stent in Herbert screw insertion vs titanium platebenefit of 3d template in fracture gap | Procedure or surgery | intervention group |
Primary outcome
inertfragmentary gap
Time frame: 3 months as after that time bone remodeling will happen and measuring the interfragmentary gap will be inaccurate
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
3 secondary outcomes
pain relief
Time frame: 3 months
nerve sensitivity
Time frame: 3 months
maximum incisal opening
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: Yes. Study results are published as partial fulfillment of the requirements for Phd degree in Oral and maxillofacial surgery by the investigator by cairo university
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussein h Abd elrahman, a professor principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing 3D stent in Herbert screw insertion vs titanium plate in people with Minimally Displaced Mandibular Angle Fracture, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nevine AE Fathy mohammed elfath omar, a lecturer (01011180702 ext. 202, vina.alex@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inertfragmentary gap (time frame: 3 months as after that time bone remodeling will happen and measuring the interfragmentary gap will be inaccurate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.