Fractured Mandible Due to TraumaNCT06363188
The Impact of ESWT on Healing of Fractured Mandible
An observational study of Fractured Mandible Due to Trauma, run by Cairo University at 1 site in Egypt.
Trial summary
studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fractured Mandible Due to Trauma
- What is being tested?
- Radial Extracorporeal shockwave
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 30 Aug 2025
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 1. Patients with age ranges from 18-75 years old. 2. Patients with fresh mandibular fractures (from zero hour till four or five days). 3. Patients free of systemic conditions that might affect or interfere with the healing process of bone segments or rather interfere with carrying out the surgical procedure (thyroid condition, rheumatoid arthritis, uncontrolled diabetes and osteoporosis).
Who may be able to join
- 1 - Patients with age ranges from 18-75 years old. 2- Patients with fresh mandibular fractures (from zero hour till four or five days).
- 3- Patients free of systemic conditions that might affect or interfere with the healing process of bone segments or rather interfere with carrying out the surgical procedure (thyroid condition, rheumatoid arthritis, uncontrolled diabetes and osteoporosis).
Who cannot join
- 1 - Patients out of the specified range group 2- Patients who went previous operations with infection or malunion. 3- Patients with thyroid condition which affects the serum calcium level. 4- Patients with systemic conditions that might affect the bone health (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes). 5- Patients with heart peacemakers.
Trial locations and contacts
1 site in 1 country.
Emad Saied, prof. contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo Univeristy
Cairo
khloud nasr eldin, GP, 01014919174, khloud.ahmed@dentistry.cu.edu.eg
Emad Saied, prof., 01222117986
About this study
Official title: The Impact of Using Extracorporeal Radial Shock Wave Therapy as an Adjuvant Therapy vs Conventional Open Reduction and Internal Fixation With No Adjuvant Therapy on Bone Healing for Patients With Mandibular Parasymphyseal, Body and Angle Fractures
studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws.
Read the detailed description
Firstly the patient heads to the operating room being placed in a supine position, generally anesthetized by the anesthesiologist.
Sterilization of intraoral and extraoral sites and draping has been installed. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used.
If the arch bar has been used it was inserted before the operation and being cut at the fracture line between the two segments.
The transoral or extra-oral approach is utilized to expose the fracture line separating the two segments.
Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate.
or even one 2.0 plate(champy) Then suturing the incision layers with vicryl 3/0. Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. The control group with no adjuvant intervention will stop at this point. The other intervention group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative.
Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site.
- Conditions
- Fractured Mandible Due to Trauma
- Being tested
- Radial Extracorporeal shockwave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal shockwaveDevice
a device used by physiotherapist to treat various musculoskeletal problems and it was here firstly used to accelerate the bone healing process after bone fracture
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Firstly the patient is generally anesthetized by the anesthesiologist. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used.
The transoral or extraoral approach is utilized to expose the fracture line separating the two segments.
Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate.
or 1 plate2.0 (champy) Then suturing the incision layers Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. This group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative.
Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site. Receives: Device: Radial Extracorporeal shockwave | |
| control group | Firstly the patient is generally anesthetized by the anesthesiologist. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used. The transoral or extraoral approach is utilized to expose the fracture line separating the two segments. Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate. or 1 plate2.0 (champy) Then suturing the incision layers Postoperative evaluation with cone beam computed tomography (CBCT). The control group with no adjuvant intervention will stop at this point. Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone healing (denisty of bone)
radiographically we will analyze the bone denisty at the fracture site
Measured: first and fourth month
Secondary outcomes (1)
pain sensation
depending on the patient using VAS
Measured: immediately after the intervention and 3 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fractured Mandible Due to TraumaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khloud Ahmed Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363188
- Sponsor's protocol ID
- effect of ESWT on fractures
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Publications
Verma S, Chambers I. Update on patterns of mandibular fracture in Tasmania, Australia. Br J Oral Maxillofac Surg. 2015 Jan;53(1):74-7. doi: 10.1016/j.bjoms.2014.10.003. Epub 2014 Nov 1.
PubMed 25453253Sirimaharaj W, Pyungtanasup K. The epidemiology of mandibular fractures treated at Chiang Mai University Hospital: a review of 198 cases. J Med Assoc Thai. 2008 Jun;91(6):868-74.
PubMed 18697387Chocron Y, Azzi AJ, Davison P. Management of Pediatric Mandibular Fractures Using Resorbable Plates. J Craniofac Surg. 2019 Oct;30(7):2111-2114. doi: 10.1097/SCS.0000000000006002.
PubMed 31568159Fridrich KL, Pena-Velasco G, Olson RA. Changing trends with mandibular fractures: a review of 1,067 cases. J Oral Maxillofac Surg. 1992 Jun;50(6):586-9. doi: 10.1016/0278-2391(92)90438-6.
PubMed 1593318Lamphier J, Ziccardi V, Ruvo A, Janel M. Complications of mandibular fractures in an urban teaching center. J Oral Maxillofac Surg. 2003 Jul;61(7):745-9; discussion 749-50. doi: 10.1016/s0278-2391(03)00147-2.
PubMed 12856243Ellis E 3rd. Complications of rigid internal fixation for mandibular fractures. J Craniomaxillofac Trauma. 1996 Summer;2(2):32-9.
PubMed 11951481Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009 Nov;91(11):2589-97. doi: 10.2106/JBJS.H.00841.
PubMed 19884432Kaspar D, Neidlinger-Wilke C, Holbein O, Claes L, Ignatius A. Mitogens are increased in the systemic circulation during bone callus healing. J Orthop Res. 2003 Mar;21(2):320-5. doi: 10.1016/S0736-0266(02)00134-1.
PubMed 12568965Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
PubMed 28850536
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using Extracorporeal Radial Shock Wave Therapy as an Adjuvant Therapy vs Conventional Open Reduction and Internal Fixation With No Adjuvant Therapy on Bone Healing for Patients With Mandibular Parasymphyseal, Body and Angle Fractures
- ClinicalTrials.gov ID
- NCT06363188
- Acronym / sponsor ID
- effect of ESWT on fractures
- Conditions
- Fractured Mandible Due to Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws.
Detailed description
Firstly the patient heads to the operating room being placed in a supine position, generally anesthetized by the anesthesiologist.
Sterilization of intraoral and extraoral sites and draping has been installed. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used.
If the arch bar has been used it was inserted before the operation and being cut at the fracture line between the two segments.
The transoral or extra-oral approach is utilized to expose the fracture line separating the two segments.
Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate.
or even one 2.0 plate(champy) Then suturing the incision layers with vicryl 3/0. Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. The control group with no adjuvant intervention will stop at this point. The other intervention group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative.
Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Device: Radial Extracorporeal shockwaveFirstly the patient is generally anesthetized by the anesthesiologist. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used. The transoral or extraoral approach is utilized to expose the fracture line separating the two segments. Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate. or 1 plate2.0 (champy) Then suturing the incision layers Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. This group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative. Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site. |
| control group | – | –Firstly the patient is generally anesthetized by the anesthesiologist. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used. The transoral or extraoral approach is utilized to expose the fracture line separating the two segments. Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate. or 1 plate2.0 (champy) Then suturing the incision layers Postoperative evaluation with cone beam computed tomography (CBCT). The control group with no adjuvant intervention will stop at this point. Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with age ranges from 18-75 years old. 2. Patients with fresh mandibular fractures (from zero hour till four or five days). 3. Patients free of systemic conditions that might affect or interfere with the healing process of bone segments or rather interfere with carrying out the surgical procedure (thyroid condition, rheumatoid arthritis, uncontrolled diabetes and osteoporosis).
Key inclusion criteria (2 listed)
- 1 - Patients with age ranges from 18-75 years old. 2- Patients with fresh mandibular fractures (from zero hour till four or five days).
- 3- Patients free of systemic conditions that might affect or interfere with the healing process of bone segments or rather interfere with carrying out the surgical procedure (thyroid condition, rheumatoid arthritis, uncontrolled diabetes and osteoporosis).
Key exclusion criteria (1 listed)
- 1 - Patients out of the specified range group 2- Patients who went previous operations with infection or malunion. 3- Patients with thyroid condition which affects the serum calcium level. 4- Patients with systemic conditions that might affect the bone health (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes). 5- Patients with heart peacemakers.
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 |
|---|---|---|
| Radial Extracorporeal shockwavea device used by physiotherapist to treat various musculoskeletal problems and it was here firstly used to accelerate the bone healing process after bone fracture | Device | intervention group |
Primary outcome
bone healing (denisty of bone)
Time frame: first and fourth month
radiographically we will analyze the bone denisty at the fracture site
1 secondary outcome
pain sensation
Time frame: immediately after the intervention and 3 days after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 25453253Verma S, Chambers I. Update on patterns of mandibular fracture in Tasmania, Australia. Br J Oral Maxillofac Surg. 2015 Jan;53(1):74-7. doi: 10.1016/j.bjoms.2014.10.003. Epub 2014 Nov 1.
- Background: PubMed 18697387Sirimaharaj W, Pyungtanasup K. The epidemiology of mandibular fractures treated at Chiang Mai University Hospital: a review of 198 cases. J Med Assoc Thai. 2008 Jun;91(6):868-74.
- Background: PubMed 31568159Chocron Y, Azzi AJ, Davison P. Management of Pediatric Mandibular Fractures Using Resorbable Plates. J Craniofac Surg. 2019 Oct;30(7):2111-2114. doi: 10.1097/SCS.0000000000006002.
- Background: PubMed 1593318Fridrich KL, Pena-Velasco G, Olson RA. Changing trends with mandibular fractures: a review of 1,067 cases. J Oral Maxillofac Surg. 1992 Jun;50(6):586-9. doi: 10.1016/0278-2391(92)90438-6.
- Background: PubMed 12856243Lamphier J, Ziccardi V, Ruvo A, Janel M. Complications of mandibular fractures in an urban teaching center. J Oral Maxillofac Surg. 2003 Jul;61(7):745-9; discussion 749-50. doi: 10.1016/s0278-2391(03)00147-2.
- Background: PubMed 11951481Ellis E 3rd. Complications of rigid internal fixation for mandibular fractures. J Craniomaxillofac Trauma. 1996 Summer;2(2):32-9.
- Background: PubMed 19884432Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009 Nov;91(11):2589-97. doi: 10.2106/JBJS.H.00841.
- Background: PubMed 12568965Kaspar D, Neidlinger-Wilke C, Holbein O, Claes L, Ignatius A. Mitogens are increased in the systemic circulation during bone callus healing. J Orthop Res. 2003 Mar;21(2):320-5. doi: 10.1016/S0736-0266(02)00134-1.
- Background: PubMed 28850536Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
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.
Emad Saied, prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractured Mandible Due to Trauma, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 1 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 khloud nasr el-din, GP. (01014919174, khloud.ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone healing (denisty of bone) (time frame: first and fourth month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06363188, which also lists 9 linked publications.
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 12 Apr 2024.