Dentofacial DeformitiesNCT05340036
Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony
A study testing Bimaxillary orthognathic surgery using conventional plates and Bimaxillary orthognathic surgery using patient specific plates in people with Dentofacial Deformities, run by Hassan Fahmy Hassan Alnimr at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the Skeletal stability of Le Fort I osteotomy using patient-specific osteosynthesis compared to Mini-plate fixation for patients with skeletal class III malocclusion. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dentofacial Deformities
- What is being tested?
- Bimaxillary orthognathic surgery using conventional plates and Bimaxillary orthognathic surgery using patient specific plates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 26 May 2022to Dec 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with skeletal class III malocclusion planned for traditional Orthognathic Approach and requiring bimaxillary orthognathic surgeries in which there will be Le Fort I osteotomy with maxillary advancement ranging from 2mm to 5 mm in addition to mandibular setback.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Who cannot join
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
+20223634965, dentmail@dentistry.cu.edu.eg
About this study
Official title: Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony. A Randomized Controlled Clinical Trial
The aim of the study is to evaluate the Skeletal stability of Le Fort I osteotomy using patient-specific osteosynthesis compared to Mini-plate fixation for patients with skeletal class III malocclusion.
Read the detailed description
postsurgical relapse is one of the most common observations that have been reported after fixation of Le Fort I osteotomy cases.
Fixation systems with plates and screws are used in oral maxillofacial surgery for the treatment of facial fractures and orthognathic surgery cases. Although they have been used for decades and have become the standard treatment, the materials used in these systems may fail due to excess loading and other causal factors during the surgical procedure, including failure in plate adaptation and fixation to bone, material design, fabrication, and degree of purity of the plate material.
In the fixation system, non-customized plates of standard size are used, and are bent to adapt them to the distances required for planning orthognathic surgeries. Therefore, mandatory use of larger plates than those programmed for use in surgeries is required so that they can be bent to enable insertion. Moreover, there are variations in the number of screws required to retain the plates to enable better fixation. The folds of non-customized plates generate stresses that are minimized when using customized plates, because these plates are fabricated individually, with predetermined sizes for each patient.
- Conditions
- Dentofacial Deformities
- Being tested
- Bimaxillary orthognathic surgery using conventional plates, Bimaxillary orthognathic surgery using patient specific plates
- Keywords
- orthognathic surgery, virtual planning, customized titanium plates, cutting guides, CAD/CAM
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimaxillary orthognathic surgery using conventional platesProcedure or surgery
le fort I osteotomy will carried out in the classic way guided by the classic landmarks (maxillary roots apices) as described by Wassmund.
Complete separation of the maxillary segment using chisels and mallets in regular fashion.
Reposition maxilla using the interocclusal wafer while mandible is gently positioned to centric relation position.
Mandible is maintained in place until fixation of the maxilla with plates and screws takes place.
Complete separation of the mandibular segment using chisels and mallets in regular fashion.
Repositioning of mandible using the final interocclusal wafer while condylar segment is gently positioned to centric relation position.
Fixation of mandibular segments with plates and/or screws in regular fashion.
Incision was closed with 4-0 resorbable sutures in a continuous running fashion.
Bimaxillary orthognathic surgery using patient specific platesProcedure or surgery
The cutting guide of the maxilla will be placed onto the exposed bony surface and manipulated to the best fit.
Then, the guide will be fixed using four 2.0-mm screws to avoid any mobilization during drilling of the reference holes. Sixteen reference holes will be established using the cutting guide; eight on each side.
Then, a reciprocating saw will be used to perform the planned Le Fort I osteotomy. After adequate maxillary mobilization and removal of bony interferences, the maxilla will be repositioned using the patient-specific osteosynthesis material guided by the previously established reference holes and fixed using 2.0-mm screws.
Then, the mandibular cutting guide will be fixed in the same manner and bilateral sagittal split osteotomy will be carried out.
After adequate mobilization, the mandible will be repositioned by the patient-specific osteosynthesis material using the reference holes made by cutting guide and fixed using 2.0-mm screws.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Conventional plates) | Active comparator | Digital intermediate and final interocclusal wafer splints will be designed to guide the maxilla and mandible in the desired position using CAD software (3-matic 11.0; Materialise NV, Leuven, Belgium).
The designed splints will be then exported in stereolithography (STL) file format to the additive CAM machine (FORMIGA P 110 printer; EOS e-manufacturing solutions, Munich, Germany) and manufactured in white polyamide (PA2200; EOS e-manufacturing solutions, Munich, Germany) using fused deposition modelling (FDM) technology.The splints will be cold sterilized by overnight immersion in 2% glutaraldehyde.
2.0 conventional mini plates will be used for fixation of maxilla and mandible in the new position. Receives: Procedure: Bimaxillary orthognathic surgery using conventional plates |
| Group II (Patient specific plates) | Experimental | The cutting guides will be designed on the maxilla and mandible to orient the osteotomy and mark reference holes to be used later for the repositioning/ fixation plate, using CAD software.
The designed guide will be then exported in stereolithography (STL) file format to the additive CAM machine and manufactured in white polyamide using fused deposition modelling (FDM) technology. No finishing or polishing was done in order to maintain accuracy. The guides will be cold sterilized by overnight immersion in 2% glutaraldehyde.
The patient-specific osteosynthesis plates will be designed to fix the maxilla and mandible in the desired position making use of the previously established reference holes. The designed plates will be exported in STL file format to be manufactured in grade 5 titanium alloy utilizing selective laser sintering (SLS) technology on an additive CAM machine. Receives: Procedure: Bimaxillary orthognathic surgery using patient specific plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal relapse of Le Fort I osteotomy
Skeletal relapse will be assessed through measuring Linear deviations (DT) between the immediate postoperative (T1) and the 12 months postoperative position (T2) in Mimics 19.0 software using hard tissue reference points (A point, Anterior nasal spine, posterior nasal spine, Incisive foramen, Right side Greater palatine foramen, Left side Greater palatine foramen) in relation to three reference planes (Frankfort horizontal plane (FHP), coronal plane, and mid-facial plane (MFP)). Measurements from the reference points to the FHP indicated vertical deviation, to the coronal plane indicated anteroposterior deviation, and to the MFP indicated mediolateral deviation. measurements will be in millimeters.
Measured: Linear deviations between immediate postoperative and 12 months postoperative position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start26 May 2022
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Dentofacial DeformitiesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hassan Fahmy Hassan Alnimr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hassan Fahmy Hassan Alnimr, Cairo University
- Investigators
- Hassan Alnimr, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340036
- Sponsor's protocol ID
- OMFS 3 3 7
- Status last verified
- May 2022
- First submitted
- 4 Apr 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Publications
Ohba S, Nakao N, Nakatani Y, Yoshimura H, Minamizato T, Kawasaki T, Yoshida N, Sano K, Asahina I. Effects of Vertical Movement of the Anterior Nasal Spine on the Maxillary Stability After LeFort I Osteotomy for Pitch Correction. J Craniofac Surg. 2015 Sep;26(6):e481-5. doi: 10.1097/SCS.0000000000001968.
PubMed 26267571Lee CC, Xhori O, Tannyhill RJ, Kaban LB, Peacock ZS. Variables associated with stability after Le Fort I osteotomy for skeletal class III malocclusion. Int J Oral Maxillofac Surg. 2021 Sep;50(9):1203-1209. doi: 10.1016/j.ijom.2021.02.004. Epub 2021 Feb 28.
PubMed 33658151Wangsrimongkol B, Flores RL, Staffenberg DA, Rodriguez ED, Shetye PR. Skeletal and Dental Correction and Stability Following LeFort I Advancement in Patients With Cleft Lip and Palate With Mild, Moderate, and Severe Maxillary Hypoplasia. Cleft Palate Craniofac J. 2022 Jan;59(1):98-109. doi: 10.1177/1055665621996108. Epub 2021 Mar 15.
PubMed 33722088Ramos VF, Pinto LAPF, Basting RT. Force and deformation stresses in customized and non-customized plates during simulation of advancement genioplasty. J Craniomaxillofac Surg. 2017 Nov;45(11):1820-1827. doi: 10.1016/j.jcms.2017.08.021. Epub 2017 Aug 31.
PubMed 28935483Stokbro K, Borg SW, Andersen MO, Thygesen T. Patient-specific 3D printed plates improve stability of Le Fort 1 osteotomies in vitro. J Craniomaxillofac Surg. 2019 Mar;47(3):394-399. doi: 10.1016/j.jcms.2018.12.015. Epub 2019 Jan 3.
PubMed 30661925Kotaniemi KVM, Heliovaara A, Kotaniemi M, Stoor P, Leikola J, Palotie T, Suojanen J. Comparison of postoperative skeletal stability of maxillary segments after Le Fort I osteotomy, using patient-specific implant versus mini-plate fixation. J Craniomaxillofac Surg. 2019 Jul;47(7):1020-1030. doi: 10.1016/j.jcms.2019.04.003. Epub 2019 Apr 27.
PubMed 31085061Buijs GJ, van Bakelen NB, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, Bos RR. A randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery. J Dent Res. 2012 Mar;91(3):299-304. doi: 10.1177/0022034511434353. Epub 2012 Jan 23.
PubMed 22269272Larsen AJ, Van Sickels JE, Thrash WJ. Postsurgical maxillary movement: a comparison study of bone plate and screw versus wire osseous fixation. Am J Orthod Dentofacial Orthop. 1989 Apr;95(4):334-43. doi: 10.1016/0889-5406(89)90167-4.
PubMed 2705414Park JH, Kim M, Kim SY, Jung HD, Jung YS. Three-dimensional analysis of maxillary stability after Le Fort I osteotomy using hydroxyapatite/poly-L-lactide plate. J Craniomaxillofac Surg. 2016 Apr;44(4):421-6. doi: 10.1016/j.jcms.2016.01.011. Epub 2016 Jan 19.
PubMed 26880012Hanafy M, Akoush Y, Abou-ElFetouh A, Mounir RM. Precision of orthognathic digital plan transfer using patient-specific cutting guides and osteosynthesis versus mixed analogue-digitally planned surgery: a randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2020 Jan;49(1):62-68. doi: 10.1016/j.ijom.2019.06.023. Epub 2019 Jun 29.
PubMed 31262680Al-Delayme R, Al-Khen M, Hamdoon Z, Jerjes W. Skeletal and dental relapses after skeletal class III deformity correction surgery: single-jaw versus double-jaw procedures. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Apr;115(4):466-72. doi: 10.1016/j.oooo.2012.08.443. Epub 2012 Nov 22.
PubMed 23177758Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.
PubMed 2161310Suojanen J, Leikola J, Stoor P. The use of patient-specific implants in orthognathic surgery: A series of 32 maxillary osteotomy patients. J Craniomaxillofac Surg. 2016 Dec;44(12):1913-1916. doi: 10.1016/j.jcms.2016.09.008. Epub 2016 Sep 23.
PubMed 27769722
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05340036
- Acronym / sponsor ID
- OMFS 3 3 7
- Conditions
- Dentofacial Deformities
- Keywords
- orthognathic surgery, virtual planning, customized titanium plates, cutting guides, CAD/CAM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hassan Fahmy Hassan AlnimrUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Apr 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.
The aim of the study is to evaluate the Skeletal stability of Le Fort I osteotomy using patient-specific osteosynthesis compared to Mini-plate fixation for patients with skeletal class III malocclusion.
Detailed description
postsurgical relapse is one of the most common observations that have been reported after fixation of Le Fort I osteotomy cases.
Fixation systems with plates and screws are used in oral maxillofacial surgery for the treatment of facial fractures and orthognathic surgery cases. Although they have been used for decades and have become the standard treatment, the materials used in these systems may fail due to excess loading and other causal factors during the surgical procedure, including failure in plate adaptation and fixation to bone, material design, fabrication, and degree of purity of the plate material.
In the fixation system, non-customized plates of standard size are used, and are bent to adapt them to the distances required for planning orthognathic surgeries. Therefore, mandatory use of larger plates than those programmed for use in surgeries is required so that they can be bent to enable insertion. Moreover, there are variations in the number of screws required to retain the plates to enable better fixation. The folds of non-customized plates generate stresses that are minimized when using customized plates, because these plates are fabricated individually, with predetermined sizes for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Conventional plates) | Active comparator | Procedure: Bimaxillary orthognathic surgery using conventional platesDigital intermediate and final interocclusal wafer splints will be designed to guide the maxilla and mandible in the desired position using CAD software (3-matic 11.0; Materialise NV, Leuven, Belgium). The designed splints will be then exported in stereolithography (STL) file format to the additive CAM machine (FORMIGA P 110 printer; EOS e-manufacturing solutions, Munich, Germany) and manufactured in white polyamide (PA2200; EOS e-manufacturing solutions, Munich, Germany) using fused deposition modelling (FDM) technology.The splints will be cold sterilized by overnight immersion in 2% glutaraldehyde. 2.0 conventional mini plates will be used for fixation of maxilla and mandible in the new position. |
| Group II (Patient specific plates) | Experimental | Procedure: Bimaxillary orthognathic surgery using patient specific platesThe cutting guides will be designed on the maxilla and mandible to orient the osteotomy and mark reference holes to be used later for the repositioning/ fixation plate, using CAD software. The designed guide will be then exported in stereolithography (STL) file format to the additive CAM machine and manufactured in white polyamide using fused deposition modelling (FDM) technology. No finishing or polishing was done in order to maintain accuracy. The guides will be cold sterilized by overnight immersion in 2% glutaraldehyde. The patient-specific osteosynthesis plates will be designed to fix the maxilla and mandible in the desired position making use of the previously established reference holes. The designed plates will be exported in STL file format to be manufactured in grade 5 titanium alloy utilizing selective laser sintering (SLS) technology on an additive CAM machine. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with skeletal class III malocclusion planned for traditional Orthognathic Approach and requiring bimaxillary orthognathic surgeries in which there will be Le Fort I osteotomy with maxillary advancement ranging from 2mm to 5 mm in addition to mandibular setback.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Key exclusion criteria (3 listed)
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
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 |
|---|---|---|
| Bimaxillary orthognathic surgery using conventional platesle fort I osteotomy will carried out in the classic way guided by the classic landmarks (maxillary roots apices) as described by Wassmund. Complete separation of the maxillary segment using chisels and mallets in regular fashion. Reposition maxilla using the interocclusal wafer while mandible is gently positioned to centric relation position. Mandible is maintained in place until fixation of the maxilla with plates and screws takes place. Complete separation of the mandibular segment using chisels and mallets in regular fashion. Repositioning of mandible using the final interocclusal wafer while condylar segment is gently positioned to centric relation position. Fixation of mandibular segments with plates and/or screws in regular fashion. Incision was closed with 4-0 resorbable sutures in a continuous running fashion. | Procedure or surgery | Group I (Conventional plates) |
| Bimaxillary orthognathic surgery using patient specific platesThe cutting guide of the maxilla will be placed onto the exposed bony surface and manipulated to the best fit. Then, the guide will be fixed using four 2.0-mm screws to avoid any mobilization during drilling of the reference holes. Sixteen reference holes will be established using the cutting guide; eight on each side. Then, a reciprocating saw will be used to perform the planned Le Fort I osteotomy. After adequate maxillary mobilization and removal of bony interferences, the maxilla will be repositioned using the patient-specific osteosynthesis material guided by the previously established reference holes and fixed using 2.0-mm screws. Then, the mandibular cutting guide will be fixed in the same manner and bilateral sagittal split osteotomy will be carried out. After adequate mobilization, the mandible will be repositioned by the patient-specific osteosynthesis material using the reference holes made by cutting guide and fixed using 2.0-mm screws. | Procedure or surgery | Group II (Patient specific plates) |
Primary outcome
Skeletal relapse of Le Fort I osteotomy
Time frame: Linear deviations between immediate postoperative and 12 months postoperative position
Skeletal relapse will be assessed through measuring Linear deviations (DT) between the immediate postoperative (T1) and the 12 months postoperative position (T2) in Mimics 19.0 software using hard tissue reference points (A point, Anterior nasal spine, posterior nasal spine, Incisive foramen, Right side Greater palatine foramen, Left side Greater palatine foramen) in relation to three reference planes (Frankfort horizontal plane (FHP), coronal plane, and mid-facial plane (MFP)). Measurements from the reference points to the FHP indicated vertical deviation, to the coronal plane indicated anteroposterior deviation, and to the MFP indicated mediolateral deviation. measurements will be in millimeters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 26267571Ohba S, Nakao N, Nakatani Y, Yoshimura H, Minamizato T, Kawasaki T, Yoshida N, Sano K, Asahina I. Effects of Vertical Movement of the Anterior Nasal Spine on the Maxillary Stability After LeFort I Osteotomy for Pitch Correction. J Craniofac Surg. 2015 Sep;26(6):e481-5. doi: 10.1097/SCS.0000000000001968.
- Background: PubMed 33658151Lee CC, Xhori O, Tannyhill RJ, Kaban LB, Peacock ZS. Variables associated with stability after Le Fort I osteotomy for skeletal class III malocclusion. Int J Oral Maxillofac Surg. 2021 Sep;50(9):1203-1209. doi: 10.1016/j.ijom.2021.02.004. Epub 2021 Feb 28.
- Background: PubMed 33722088Wangsrimongkol B, Flores RL, Staffenberg DA, Rodriguez ED, Shetye PR. Skeletal and Dental Correction and Stability Following LeFort I Advancement in Patients With Cleft Lip and Palate With Mild, Moderate, and Severe Maxillary Hypoplasia. Cleft Palate Craniofac J. 2022 Jan;59(1):98-109. doi: 10.1177/1055665621996108. Epub 2021 Mar 15.
- Background: PubMed 28935483Ramos VF, Pinto LAPF, Basting RT. Force and deformation stresses in customized and non-customized plates during simulation of advancement genioplasty. J Craniomaxillofac Surg. 2017 Nov;45(11):1820-1827. doi: 10.1016/j.jcms.2017.08.021. Epub 2017 Aug 31.
- Background: PubMed 30661925Stokbro K, Borg SW, Andersen MO, Thygesen T. Patient-specific 3D printed plates improve stability of Le Fort 1 osteotomies in vitro. J Craniomaxillofac Surg. 2019 Mar;47(3):394-399. doi: 10.1016/j.jcms.2018.12.015. Epub 2019 Jan 3.
- Background: PubMed 31085061Kotaniemi KVM, Heliovaara A, Kotaniemi M, Stoor P, Leikola J, Palotie T, Suojanen J. Comparison of postoperative skeletal stability of maxillary segments after Le Fort I osteotomy, using patient-specific implant versus mini-plate fixation. J Craniomaxillofac Surg. 2019 Jul;47(7):1020-1030. doi: 10.1016/j.jcms.2019.04.003. Epub 2019 Apr 27.
- Background: PubMed 22269272Buijs GJ, van Bakelen NB, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, Bos RR. A randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery. J Dent Res. 2012 Mar;91(3):299-304. doi: 10.1177/0022034511434353. Epub 2012 Jan 23.
- Background: PubMed 2705414Larsen AJ, Van Sickels JE, Thrash WJ. Postsurgical maxillary movement: a comparison study of bone plate and screw versus wire osseous fixation. Am J Orthod Dentofacial Orthop. 1989 Apr;95(4):334-43. doi: 10.1016/0889-5406(89)90167-4.
- Background: PubMed 26880012Park JH, Kim M, Kim SY, Jung HD, Jung YS. Three-dimensional analysis of maxillary stability after Le Fort I osteotomy using hydroxyapatite/poly-L-lactide plate. J Craniomaxillofac Surg. 2016 Apr;44(4):421-6. doi: 10.1016/j.jcms.2016.01.011. Epub 2016 Jan 19.
- Background: PubMed 31262680Hanafy M, Akoush Y, Abou-ElFetouh A, Mounir RM. Precision of orthognathic digital plan transfer using patient-specific cutting guides and osteosynthesis versus mixed analogue-digitally planned surgery: a randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2020 Jan;49(1):62-68. doi: 10.1016/j.ijom.2019.06.023. Epub 2019 Jun 29.
- Background: PubMed 23177758Al-Delayme R, Al-Khen M, Hamdoon Z, Jerjes W. Skeletal and dental relapses after skeletal class III deformity correction surgery: single-jaw versus double-jaw procedures. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Apr;115(4):466-72. doi: 10.1016/j.oooo.2012.08.443. Epub 2012 Nov 22.
- Background: PubMed 2161310Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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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.
Hassan Alnimr principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bimaxillary orthognathic surgery using conventional plates and Bimaxillary orthognathic surgery using patient specific plates in people with Dentofacial Deformities, run by Hassan Fahmy Hassan Alnimr 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 3 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 1 Jun 2022. 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 Hassan Alnimr (+201002961175, hassan-fahmy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal relapse of Le Fort I osteotomy (time frame: Linear deviations between immediate postoperative and 12 months postoperative position). 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 NCT05340036, which also lists 13 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 1 Jun 2022.