Retruded Hypoplastic MaxillaNCT03752944
Comparison Between Prebent & Miniplates in Fixation of Lefort I Osteotomty in Maxillary Advancement.
A study testing lefort I osteotomy for maxillary advancement in people with Retruded Hypoplastic Maxilla, run by Cairo University.
Trial summary
In patients with retruded maxilla ,Will the use of two prebent plates produce more stable results postoperatively in fixation of Le Fort I osteotomy in maxillary advancement than conventional four minplates ? Many studies have been conducted to compare between the two plates and these studies showed that the prebent… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Retruded Hypoplastic Maxilla
- What is being tested?
- lefort I osteotomy for maxillary advancement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with retruded maxilla \& need advancement by le fort I osteotomy.
- Patients free from any systemic disease \& bone metabolism diseases.
- Patients with no signs or symptoms of temporomandibular joint disorders.
- No sex predilection
- Age range ( 18-45)
Who cannot join
- Patients with systemic disease \& bone metabolism diseases.
- Patients with cleft lip \& palate.
- Patients with temporomandibular joint disorders
- Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing
- Age less than 18
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Stability of Maxillary Advancement by Lefort I Osteotomy in Patients With Retruded Maxilla Fixed With Two Prebent Plates Versus Four Miniplates. (Randomised Clinical Trial.)
In patients with retruded maxilla ,Will the use of two prebent plates produce more stable results postoperatively in fixation of Le Fort I osteotomy in maxillary advancement than conventional four minplates ? Many studies have been conducted to compare between the two plates and these studies showed that the prebent plate, the plate is not excessively twisted so that it can be adapted passively leading to less changes in the property of the material ,increased titanium contact surface to the bone leading to better force distribution resulting in better rigid fixation as no stresses will be transmitted from the plate to the bone leading to faster bone healing and consequently better long term postoperative stability.
Read the detailed description
The stability of maxillary advancement after Le Fort I osteotomy in retruded maxilla patients has been an issue that has attracted the attention of numerous researchers. That's why different fixation methods have been compared in vitro and in vivo.
Prebent plates is one of the recent modifications of the plate systems used in maxillofacial surgery , they were created to reduce the need for bending and contouring of the titanium miniplates.
Lye et al.,(the only in vivo study in English), aimed to evaluate the predictability of advancement surgery with the use of prebent plates in 36 patients \& he proved the prebent plates have been proven to significantly affect the advancement \& reliable.
In a biomechanical study, prebent plates provided better results than the standard two plate scenario in terms of resistance to displacement, permanent deformation and load for breaking.
Fatih Mehmet Coskunses et al., in 2015 has done in vitro study to evaluate the segmental displacement, and von mises stress on the titanium miniplates \& the maximum principal stress on the bone, with the use of prebent plates and two standard L plates adapted to either the zygomaticomaxillary buttress or the nasal piriform following anterior advancement of 5 mm or 10 mm by Le Fort I osteotomy.
The results of the study were, In 5 mm maxillary advancement using prebent plates for the fixation of bone segments resulted in less segmental displacement than the standard two plate.
Even when adapted posteriorly or anteriorly, the prebent plates were able to be more stable than two plates technique. Moreover, Not only the one prebent scenario had the lowest segmental displacements, but also the lowest maximum principal stresses on bone in the anteriorly adapted group.
These results are due to the structure of the prebent plates that have two arms extending in opposite directions (anteriorly and posteriorly) and it is suggested that the prebent plates are preferable alternatives to the traditional two plate configurations in osteotomies with up to 5 mm advancement. The prebent plates showed similar satisfactory results with 10 mm advancement only when adapted anteriorly. In contrast, when adapted posteriorly, the prebent plates resulted in obvious failure in the 10 mm advancement model.
Based on these data , My research will compare the postoperative stability between 2 groups of retruded maxilla patients having maxillary advancement up to 5 mm
- the 1st group will be fixed using 2 prebent plates placed at nasal piriform
- the 2nd group will be fixed using 4 miniplates placed at nasal piriform \& zygmoaticomaxillay buttress.
The aim of this study:
To find out if the two prebent plates provides a stable postoperative maxillary advancement movement than the traditional four miniplates.
- Conditions
- Retruded Hypoplastic Maxilla
- Being tested
- lefort I osteotomy for maxillary advancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lefort I osteotomy for maxillary advancementProcedure or surgery
Also called four miniplates
fixation of lefort I osteotomy in patients with retruded maxilla with two prebent plates versus four miniplates.
| Study group | Role | What they receive |
|---|---|---|
| prebent plate | Experimental | fixation of le fort I osteotomy using prebent plate Receives: Procedure: lefort I osteotomy for maxillary advancement |
| Conventional four miniplates | Active comparator | fixation of le fort I osteotomy using conventional four miniplates Receives: Procedure: lefort I osteotomy for maxillary advancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary stability
Linear measurements (from A point to the nasion perpendicular, A point perpendicular to Frankfort plane) \& Angular measurements (SNA , Maxillary depth angle ) will be obtained from the immediate postoperative lateral cephalometry and after 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retruded Hypoplastic MaxillaStudies 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
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Mahmoud Ahmed Mohamed, Cairo University
- Investigators
- Hagar A Mohamed, BDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752944
- Sponsor's protocol ID
- CEBD-CU-2018-11-19
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coskunses FM, Kan B, Mutlu I, Cilasun U, Celik T. Evaluation of prebent miniplates in fixation of Le Fort I advancement osteotomy with the finite element method. J Craniomaxillofac Surg. 2015 Oct;43(8):1505-10. doi: 10.1016/j.jcms.2015.07.004. Epub 2015 Jul 15.
PubMed 26297421
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of Maxillary Advancement by Lefort I Osteotomy in Patients With Retruded Maxilla Fixed With Two Prebent Plates Versus Four Miniplates. (Randomised Clinical Trial.)
- ClinicalTrials.gov ID
- NCT03752944
- Acronym / sponsor ID
- CEBD-CU-2018-11-19
- Conditions
- Retruded Hypoplastic Maxilla
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Nov 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.
In patients with retruded maxilla ,Will the use of two prebent plates produce more stable results postoperatively in fixation of Le Fort I osteotomy in maxillary advancement than conventional four minplates ? Many studies have been conducted to compare between the two plates and these studies showed that the prebent plate, the plate is not excessively twisted so that it can be adapted passively leading to less changes in the property of the material ,increased titanium contact surface to the bone leading to better force distribution resulting in better rigid fixation as no stresses will be transmitted from the plate to the bone leading to faster bone healing and consequently better long term postoperative stability.
Detailed description
The stability of maxillary advancement after Le Fort I osteotomy in retruded maxilla patients has been an issue that has attracted the attention of numerous researchers. That's why different fixation methods have been compared in vitro and in vivo.
Prebent plates is one of the recent modifications of the plate systems used in maxillofacial surgery , they were created to reduce the need for bending and contouring of the titanium miniplates.
Lye et al.,(the only in vivo study in English), aimed to evaluate the predictability of advancement surgery with the use of prebent plates in 36 patients \& he proved the prebent plates have been proven to significantly affect the advancement \& reliable.
In a biomechanical study, prebent plates provided better results than the standard two plate scenario in terms of resistance to displacement, permanent deformation and load for breaking.
Fatih Mehmet Coskunses et al., in 2015 has done in vitro study to evaluate the segmental displacement, and von mises stress on the titanium miniplates \& the maximum principal stress on the bone, with the use of prebent plates and two standard L plates adapted to either the zygomaticomaxillary buttress or the nasal piriform following anterior advancement of 5 mm or 10 mm by Le Fort I osteotomy.
The results of the study were, In 5 mm maxillary advancement using prebent plates for the fixation of bone segments resulted in less segmental displacement than the standard two plate.
Even when adapted posteriorly or anteriorly, the prebent plates were able to be more stable than two plates technique. Moreover, Not only the one prebent scenario had the lowest segmental displacements, but also the lowest maximum principal stresses on bone in the anteriorly adapted group.
These results are due to the structure of the prebent plates that have two arms extending in opposite directions (anteriorly and posteriorly) and it is suggested that the prebent plates are preferable alternatives to the traditional two plate configurations in osteotomies with up to 5 mm advancement. The prebent plates showed similar satisfactory results with 10 mm advancement only when adapted anteriorly. In contrast, when adapted posteriorly, the prebent plates resulted in obvious failure in the 10 mm advancement model.
Based on these data , My research will compare the postoperative stability between 2 groups of retruded maxilla patients having maxillary advancement up to 5 mm
- the 1st group will be fixed using 2 prebent plates placed at nasal piriform
- the 2nd group will be fixed using 4 miniplates placed at nasal piriform \& zygmoaticomaxillay buttress.
The aim of this study:
To find out if the two prebent plates provides a stable postoperative maxillary advancement movement than the traditional four miniplates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| prebent plate | Experimental | Procedure: lefort I osteotomy for maxillary advancementfixation of le fort I osteotomy using prebent plate |
| Conventional four miniplates | Active comparator | Procedure: lefort I osteotomy for maxillary advancementfixation of le fort I osteotomy using conventional four miniplates |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with retruded maxilla \& need advancement by le fort I osteotomy.
- Patients free from any systemic disease \& bone metabolism diseases.
- Patients with no signs or symptoms of temporomandibular joint disorders.
- No sex predilection
- Age range ( 18-45)
Key exclusion criteria (5 listed)
- Patients with systemic disease \& bone metabolism diseases.
- Patients with cleft lip \& palate.
- Patients with temporomandibular joint disorders
- Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing
- Age less than 18
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 |
|---|---|---|
| lefort I osteotomy for maxillary advancementAlso: four miniplatesfixation of lefort I osteotomy in patients with retruded maxilla with two prebent plates versus four miniplates. | Procedure or surgery | Conventional four miniplates, prebent plate |
Primary outcome
Maxillary stability
Time frame: 12 months
Linear measurements (from A point to the nasion perpendicular, A point perpendicular to Frankfort plane) \& Angular measurements (SNA , Maxillary depth angle ) will be obtained from the immediate postoperative lateral cephalometry and after 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Background: PubMed 26297421Coskunses FM, Kan B, Mutlu I, Cilasun U, Celik T. Evaluation of prebent miniplates in fixation of Le Fort I advancement osteotomy with the finite element method. J Craniomaxillofac Surg. 2015 Oct;43(8):1505-10. doi: 10.1016/j.jcms.2015.07.004. Epub 2015 Jul 15.
- Individual participant dataSharing planned: No
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.
Hagar A Mohamed, BDS principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing lefort I osteotomy for maxillary advancement in people with Retruded Hypoplastic Maxilla, 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 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 26 Nov 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 Hagar A Mohamed, BDS (01016799911, hagar_elsherif92@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary stability (time frame: 12 months). 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 NCT03752944, which also lists 1 linked publication.
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 Nov 2018.