Mandibular FracturesNCT04518956
Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing
A study testing inter maxillary fixation with shockwave therapy, Inter maxillary fixation and exposure to low intensity pulsed and Inter maxillary fixation in people with Mandibular Fractures, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- inter maxillary fixation with shockwave therapy, Inter maxillary fixation and exposure to low intensity pulsed and Inter maxillary fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2016to 23 Jun 2018
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- -Patients having the following criteria will be excluded scars, burns, infection in the Skin in the relevant working area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between the Effect of Shockwave Therapy and Low-intensity Pulsed Ultrasound (LIPUS) on Bone Healing of Mandibular Fracture
compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures
Read the detailed description
The mandible is the commonest facial bone to fracture. Mandibular fractures represent more than 74% of all maxillofacial fractures.
To compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures.
A total of 21 patients; aged between 20-40 years, who have mandibular fracture were selected for this study from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. In this study all patients were subjected to closed reduction and intermaxillary fixation. This will be followed by shockwave therapy in seven patients as a study group and by low-intensity pulsed ultrasound in seven patients as study group. Seven patients will receive neither and will constitute the control group.
- Conditions
- Mandibular Fractures
- Being tested
- inter maxillary fixation with shockwave therapy, Inter maxillary fixation and exposure to low intensity pulsed, Inter maxillary fixation
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inter maxillary fixation with shockwave therapyProcedure or surgery
Shockwave therapy device which give 1500-4000 pulses per session with or without anesthesia, and the treatment session takes approximately 5-10 minutes at the day after surgery.
Inter maxillary fixation and exposure to low intensity pulsedProcedure or surgery
Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.
Inter maxillary fixationProcedure or surgery
Closed reduction will be done. Intermaxillary fixation (IMF) will be secured after proper reduction of the fractured segments to assure proper occlusion using upper and lower arch bars or eyelet wires for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Inter maxillary fixation and exposure to shockwave therapy | Experimental | Not described Receives: Procedure: inter maxillary fixation with shockwave therapy |
| Inter maxillary fixation and exposure to low intensity pulsed | Experimental | Not described Receives: Procedure: Inter maxillary fixation and exposure to low intensity pulsed |
| Inter maxillary fixation only | Active comparator | Not described Receives: Procedure: Inter maxillary fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scale
pain was scores using visual analouge scale from 0 to 10 0 means no pain 10 most severe pain
Measured: after 24 hours and 1 week
Change in bone density
using CT
Measured: after 6 Weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start18 Dec 2016
- Primary completion7 Feb 2018
- Study completion23 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518956
- Sponsor's protocol ID
- Mandibular fracture healing
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Shockwave Therapy and Low-intensity Pulsed Ultrasound (LIPUS) on Bone Healing of Mandibular Fracture
- ClinicalTrials.gov ID
- NCT04518956
- Acronym / sponsor ID
- Mandibular fracture healing
- Conditions
- Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 18 Dec 2016 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 23 Jun 2018 (actual)
- First posted
- 19 Aug 2020 (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.
compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures
Detailed description
The mandible is the commonest facial bone to fracture. Mandibular fractures represent more than 74% of all maxillofacial fractures.
To compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures.
A total of 21 patients; aged between 20-40 years, who have mandibular fracture were selected for this study from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. In this study all patients were subjected to closed reduction and intermaxillary fixation. This will be followed by shockwave therapy in seven patients as a study group and by low-intensity pulsed ultrasound in seven patients as study group. Seven patients will receive neither and will constitute the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inter maxillary fixation and exposure to shockwave therapy | Experimental | Procedure: inter maxillary fixation with shockwave therapy |
| Inter maxillary fixation and exposure to low intensity pulsed | Experimental | Procedure: Inter maxillary fixation and exposure to low intensity pulsed |
| Inter maxillary fixation only | Active comparator | Procedure: Inter maxillary fixation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -Patients having the following criteria will be excluded scars, burns, infection in the Skin in the relevant working area
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 |
|---|---|---|
| inter maxillary fixation with shockwave therapyShockwave therapy device which give 1500-4000 pulses per session with or without anesthesia, and the treatment session takes approximately 5-10 minutes at the day after surgery. | Procedure or surgery | Inter maxillary fixation and exposure to shockwave therapy |
| Inter maxillary fixation and exposure to low intensity pulsedLow-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery. | Procedure or surgery | Inter maxillary fixation and exposure to low intensity pulsed |
| Inter maxillary fixationClosed reduction will be done. Intermaxillary fixation (IMF) will be secured after proper reduction of the fractured segments to assure proper occlusion using upper and lower arch bars or eyelet wires for six weeks. | Procedure or surgery | Inter maxillary fixation only |
Primary outcome
Change in pain scale
Time frame: after 24 hours and 1 week
pain was scores using visual analouge scale from 0 to 10 0 means no pain 10 most severe pain
Change in bone density
Time frame: after 6 Weeks and 12 weeks
using CT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inter maxillary fixation with shockwave therapy, Inter maxillary fixation and exposure to low intensity pulsed and Inter maxillary fixation in people with Mandibular Fractures, run by Hams Hamed Abdelrahman 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 0 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: finished, as of the sponsor's last update on 19 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scale (time frame: after 24 hours and 1 week). The study lists 2 primary outcomes in all. 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 19 Aug 2020.