Mandibular FracturesNCT04443998
Mandibular Fracture Reduction Using Bone Reduction Forceps
A study testing Bone reducion forceps in people with Mandibular Fractures, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Bone reducion forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Oct 2019to 1 Sep 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged from 20 to 45 years will be included.
- Patients suffered from recent and uninfected.
- Patients with isolated mandibular fractures.
Who cannot join
- Medically compromised patients that will be not fit for surgery.
- Edentulous patients.
- Non-displaced
- Comminuted fracture with bone loss
- Old fracture, more than 3 weeks
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Evaluation of Bone Reduction Forceps in Reducing Mandibular Fracture
Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments.
Read the detailed description
The aim of this study is to evaluate clinically and radiographically the effect of using bone reduction forceps in the reduction of isolated mandibular fractures.
10 patients complaining of isolated mandibular fractures in need of open reduction and internal fixation underwent reduction using bone reduction forceps.
The patients followed up clinically after 1 and 2 weeks, 1, 3, and 6 months postoperatively. Radiographic evaluation will be performed by computed tomography (CT) preoperatively, and cone-beam computed tomography (CBCT) will be done after 3 and 6 months
- Conditions
- Mandibular Fractures
- Being tested
- Bone reducion forceps
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone reducion forcepsDevice
Repositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction
| Study group | Role | What they receive |
|---|---|---|
| Bone reduction forceps | Experimental | Not described Receives: Device: Bone reducion forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiodensitometric measurements
cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture
Measured: at 3rd, 6th months
change in maximal mouth opening
maximal interincisal opening between maxillary and mandibular central incisors.
Measured: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
change in occlusion
Any occlusal disturbance including open bite or improper tooth contact will be recorded
Measured: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
change in pain level
Pain: will be measured on Visual Analogue Scale (VAS). The patients will be asked to rate their postoperative pain on a 4-point scale (0= none, 1= slight, 2= moderate, 3- severe)
Measured: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start16 Oct 2019
- Primary completion18 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT04443998
- Sponsor's protocol ID
- Mandibular fracture reduction
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 23 Jun 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 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Reduction Forceps in Reducing Mandibular Fracture
- ClinicalTrials.gov ID
- NCT04443998
- Acronym / sponsor ID
- Mandibular fracture reduction
- Conditions
- Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 18 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 23 Jun 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.
Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments.
Detailed description
The aim of this study is to evaluate clinically and radiographically the effect of using bone reduction forceps in the reduction of isolated mandibular fractures.
10 patients complaining of isolated mandibular fractures in need of open reduction and internal fixation underwent reduction using bone reduction forceps.
The patients followed up clinically after 1 and 2 weeks, 1, 3, and 6 months postoperatively. Radiographic evaluation will be performed by computed tomography (CT) preoperatively, and cone-beam computed tomography (CBCT) will be done after 3 and 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone reduction forceps | Experimental | Device: Bone reducion forceps |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aged from 20 to 45 years will be included.
- Patients suffered from recent and uninfected.
- Patients with isolated mandibular fractures.
Key exclusion criteria (5 listed)
- Medically compromised patients that will be not fit for surgery.
- Edentulous patients.
- Non-displaced
- Comminuted fracture with bone loss
- Old fracture, more than 3 weeks
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 |
|---|---|---|
| Bone reducion forcepsRepositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction | Device | Bone reduction forceps |
Primary outcome
Change in radiodensitometric measurements
Time frame: at 3rd, 6th months
cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture
change in maximal mouth opening
Time frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
maximal interincisal opening between maxillary and mandibular central incisors.
change in occlusion
Time frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Any occlusal disturbance including open bite or improper tooth contact will be recorded
change in pain level
Time frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Pain: will be measured on Visual Analogue Scale (VAS). The patients will be asked to rate their postoperative pain on a 4-point scale (0= none, 1= slight, 2= moderate, 3- severe)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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 Bone reducion forceps 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 3 inclusion and 5 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 23 Jun 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?
Results are not available in the source record.
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 radiodensitometric measurements (time frame: at 3rd, 6th months). The study lists 4 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 23 Jun 2020.