Mandibular FracturesNCT05401994
Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
A study testing screw retained arch bar and conventional Erich's Arch Bar in people with Mandibular Fractures, run by Mansoura University at 1 site in Egypt.
Trial summary
A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- screw retained arch bar and conventional Erich's Arch Bar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Feb 2023
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients age ranges from 18 to 50 years.
- Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.
- Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.
Who cannot join
- 1) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.
Trial locations and contacts
1 site in 1 country.
About this study
A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation
Read the detailed description
- Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.
- Conditions
- Mandibular Fractures
- Being tested
- screw retained arch bar, conventional Erich's Arch Bar
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screw retained arch barProcedure or surgery
maxillomandibular fixation with bone screwed arch bar
conventional Erich's Arch BarProcedure or surgery
maxillomandibular fixation with conventional arch bar fixed to the teeth
| Study group | Role | What they receive |
|---|---|---|
| conventional Erich's arch bar | Active comparator | • Patients will receive conventional Erich's arch bar Receives: Procedure: conventional Erich's Arch Bar |
| Screw Retained Arch Bar | Experimental | patients will receive modified screw retained arch bar. Receives: Procedure: screw retained arch bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of surgical procedure in minutes
Duration between the starting of fixation and complete fixation of fracture
Measured: intraoperative
maxillomandibular fixation stability in nominal scale(stable-unstable)
stability after fixation
Measured: immediately postoperative
maxillomandibular fixation stability in nominal scale(stable-unstable)
stability after fixation
Measured: 4-6 weeks
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
Measured: immediately postoperative
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
Measured: 4-6 weeks
Secondary outcomes (3)
number of iatrogenic injuries
iatrogenic injuries to teeth and gingiva
Measured: intraoperative
number of needle and wire stick injuries
injuries to the surgeon and the assistants.
Measured: intraoperative
pain assessment using numeric rating scale (NRS)
participants rated their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Sep 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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.
- More trials run by Mansoura 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401994
- Sponsor's protocol ID
- A03080921
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
- ClinicalTrials.gov ID
- NCT05401994
- Acronym / sponsor ID
- A03080921
- Conditions
- Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 2 Jun 2022 (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.
A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation
Detailed description
- Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional Erich's arch bar | Active comparator | Procedure: conventional Erich's Arch Bar• Patients will receive conventional Erich's arch bar |
| Screw Retained Arch Bar | Experimental | Procedure: screw retained arch barpatients will receive modified screw retained arch bar. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The patients age ranges from 18 to 50 years.
- Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.
- Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.
Key exclusion criteria (1 listed)
- 1) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.
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 |
|---|---|---|
| screw retained arch barmaxillomandibular fixation with bone screwed arch bar | Procedure or surgery | Screw Retained Arch Bar |
| conventional Erich's Arch Barmaxillomandibular fixation with conventional arch bar fixed to the teeth | Procedure or surgery | conventional Erich's arch bar |
Primary outcome
duration of surgical procedure in minutes
Time frame: intraoperative
Duration between the starting of fixation and complete fixation of fracture
maxillomandibular fixation stability in nominal scale(stable-unstable)
Time frame: immediately postoperative
stability after fixation
maxillomandibular fixation stability in nominal scale(stable-unstable)
Time frame: 4-6 weeks
stability after fixation
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
Time frame: immediately postoperative
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
Time frame: 4-6 weeks
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
3 secondary outcomes
number of iatrogenic injuries
Time frame: intraoperative
number of needle and wire stick injuries
Time frame: intraoperative
pain assessment using numeric rating scale (NRS)
Time frame: immediately postoperative
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 10 Apr 2023.
- Individual participant dataSharing planned: No
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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 screw retained arch bar and conventional Erich's Arch Bar in people with Mandibular Fractures, run by Mansoura 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 3 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 10 Apr 2023. 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?
duration of surgical procedure in minutes (time frame: intraoperative). The study lists 5 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 10 Apr 2023.