Mandibular PrognathismNCT03855072
Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism
A study testing customized fixation plate and maxillomandibular fixation in people with Mandibular Prognathism, run by Cairo University.
Trial summary
Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Mandibular Prognathism
- What is being tested?
- customized fixation plate and maxillomandibular fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Aug 2022
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All subjects were required:
- Patients with mandibular prognanthism indicated for mandibular setback.
- All ages >18 years
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance
Who cannot join
- History of mandibular trauma
- Previous orthognathic surgery
- Degenerative disease of temporomandibular joint
- Craniofacial syndrome such as cleft lip or palate
- Follow up period will be less than 6 months
About this study
Official title: Patient Satisfaction Following Vertical Ramus Osteotomy After Mandibular Setback Fixed With Patients Specific Osteosynthesis and Immediate Mobilization Versus Vertical Ramus Osteotomy Fixed With MMFin Patients With Mandibular Prognanthism
Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate
Read the detailed description
Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate
Interventions:
General operative procedures
Eligible patients will be randomized in equal proportions between the study group (customized plate fixation of VRO) and the control group (maxillomandibular fixation of VRO).
Patients of Both groups will be subjected to:
- Case history including personal data, medical, surgical history and family history
- Clinical examination .
- Radiographic examination in the form of cephalometric radiogragh .
- Preoperative laboratory tests (complete blood cell count, Hemoglobin count, coagulation profile, liver function, kidney function and blood glucose level).
- Preoperative anesthesia assessment for fitness for general anesthesia. vertical ramus osteotmy fixed with customized plate
- All cases will undergo one surgery under general anesthesia.
- Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
- Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
- The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. The osteotomy is placed 5 mm anterior to the posterior border of the mandible to avoid injury to the inferior alveolar neurovascular bundle
- 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
- The setback will be simulated according to pre-planned measure
- The customized bone plate is positioned to fix the proximal and distal segment together vertical ramus osteotomy fixed with MMF.
- All cases will undergo one surgery under general anesthesia.
- incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
- Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
- The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. The osteotomy is placed 5 mm anterior to the posterior border of the mandible to avoid injury to inferior alveolar neurovascular bundle.
- Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position. follow up clinical and radiographic evaluation will be performed at the first week postoperative then the patients will recalled for radiograghic evaluation at 2weeks and 2 months .finall follow up visit will be at 6 months postoperative
- Conditions
- Mandibular Prognathism
- Being tested
- customized fixation plate, maxillomandibular fixation
- Keywords
- Mandibular Prognanthism,customized plate
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized fixation plateProcedure or surgery
Also called patient specific osteosynthesis
- All cases will undergo one surgery under general anesthesia.
- Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
- Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
- The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
- 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
- The customized fixation plate is positioned to fix the proximal and distal segment together after setback
maxillomandibular fixationProcedure or surgery
Also called intermaxillary fixation
- All cases will undergo one surgery under general anesthesia.
- incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
- The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
- Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position.
| Study group | Role | What they receive |
|---|---|---|
| Customized plate fixation | Experimental | Customized Plate fixation of Vertical Ramus Osteotomy after Mandibular Setback
- intervention:
* All cases will undergo one surgery under general anesthesia.
* Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
* The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
* 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
* The customized fixation plate is positioned to fix the proximal and distal segment together Receives: Procedure: customized fixation plate |
| maxillomandibular fixation | Active comparator | Mandibular Setback by Vertical Ramus Ostotmy fixed with Maxillomandibular fixation
- intervention:
* All cases will undergo one surgery under general anesthesia
* incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
* The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
* Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint Receives: Procedure: maxillomandibular fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient were asked to fill out a questionnaire in order to investigate their satisfaction degree after surgery ,according to an adapted (10 cm) visual analogue scale (VAS) from 0 to +10 0 is the least satisfied 10 is the most satisfied
Measured: immediately postoperative
Secondary outcomes (1)
stability of Mandible
assessed by determining the differences between measurements of three mandibular reference points (B-point, menton, and pogonion) in relation to SNy ,SNx axis obtained at six different time points
Measured: pre- operative , 2 weeks postoperative , 2 months postoperative , 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study startJun 2019 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular PrognathismStudies 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
- * A Randomized Controlled Trial * A Trial will be carried out in Hospital of Oral and Maxillofacial surgery departement- faculty of Dentistry , Cairo University * Equal randomization : participant with equal probabilities for intervention * Parallel group study : Each group of patients recieves a single treatment simultaneously
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Sayed Abbass Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855072
- Sponsor's protocol ID
- Goal NO 5 , OMFS IV A3
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction Following Vertical Ramus Osteotomy After Mandibular Setback Fixed With Patients Specific Osteosynthesis and Immediate Mobilization Versus Vertical Ramus Osteotomy Fixed With MMFin Patients With Mandibular Prognanthism
- ClinicalTrials.gov ID
- NCT03855072
- Acronym / sponsor ID
- Goal NO 5 , OMFS IV A3
- Conditions
- Mandibular Prognathism
- Keywords
- Mandibular Prognanthism,customized plate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 26 Feb 2019 (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.
Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate
Detailed description
Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate
Interventions:
General operative procedures
Eligible patients will be randomized in equal proportions between the study group (customized plate fixation of VRO) and the control group (maxillomandibular fixation of VRO).
Patients of Both groups will be subjected to:
- Case history including personal data, medical, surgical history and family history
- Clinical examination .
- Radiographic examination in the form of cephalometric radiogragh .
- Preoperative laboratory tests (complete blood cell count, Hemoglobin count, coagulation profile, liver function, kidney function and blood glucose level).
- Preoperative anesthesia assessment for fitness for general anesthesia. vertical ramus osteotmy fixed with customized plate
- All cases will undergo one surgery under general anesthesia.
- Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
- Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
- The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. The osteotomy is placed 5 mm anterior to the posterior border of the mandible to avoid injury to the inferior alveolar neurovascular bundle
- 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
- The setback will be simulated according to pre-planned measure
- The customized bone plate is positioned to fix the proximal and distal segment together vertical ramus osteotomy fixed with MMF.
- All cases will undergo one surgery under general anesthesia.
- incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
- Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
- The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. The osteotomy is placed 5 mm anterior to the posterior border of the mandible to avoid injury to inferior alveolar neurovascular bundle.
- Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position. follow up clinical and radiographic evaluation will be performed at the first week postoperative then the patients will recalled for radiograghic evaluation at 2weeks and 2 months .finall follow up visit will be at 6 months postoperative
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * A Randomized Controlled Trial * A Trial will be carried out in Hospital of Oral and Maxillofacial surgery departement- faculty of Dentistry , Cairo University * Equal randomization : participant with equal probabilities for intervention * Parallel group study : Each group of patients recieves a single treatment simultaneously
| Arm | Type | Receives |
|---|---|---|
| Customized plate fixation | Experimental | Procedure: customized fixation plateCustomized Plate fixation of Vertical Ramus Osteotomy after Mandibular Setback - intervention: * All cases will undergo one surgery under general anesthesia. * Incision was made medial to external oblique ridge from the asendindg ramus to second molar region * The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. * 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS * The customized fixation plate is positioned to fix the proximal and distal segment together |
| maxillomandibular fixation | Active comparator | Procedure: maxillomandibular fixationMandibular Setback by Vertical Ramus Ostotmy fixed with Maxillomandibular fixation - intervention: * All cases will undergo one surgery under general anesthesia * incision was made medial to external oblique ridge from the asendindg ramus to second molar region . * The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. * Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with mandibular prognanthism indicated for mandibular setback.
- All ages >18 years
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance
Key exclusion criteria (5 listed)
- History of mandibular trauma
- Previous orthognathic surgery
- Degenerative disease of temporomandibular joint
- Craniofacial syndrome such as cleft lip or palate
- Follow up period will be less than 6 months
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 |
|---|---|---|
| customized fixation plateAlso: patient specific osteosynthesis* All cases will undergo one surgery under general anesthesia. * Incision was made medial to external oblique ridge from the asendindg ramus to second molar region * Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch * The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. * 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS * The customized fixation plate is positioned to fix the proximal and distal segment together after setback | Procedure or surgery | Customized plate fixation |
| maxillomandibular fixationAlso: intermaxillary fixation* All cases will undergo one surgery under general anesthesia. * incision was made medial to external oblique ridge from the asendindg ramus to second molar region . * The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. * Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position. | Procedure or surgery | maxillomandibular fixation |
Primary outcome
Patient Satisfaction
Time frame: immediately postoperative
Patient were asked to fill out a questionnaire in order to investigate their satisfaction degree after surgery ,according to an adapted (10 cm) visual analogue scale (VAS) from 0 to +10 0 is the least satisfied 10 is the most satisfied
1 secondary outcome
stability of Mandible
Time frame: pre- operative , 2 weeks postoperative , 2 months postoperative , 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
Related trials for Mandibular Prognathism
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Evaluating the Accuracy of Soft Tissue Prediction in Patients With Mandibular Prognathism After Orthognathic Surgery Using Handheld Scanner Versus Optical Scanner A Prospective Clinical Trial
Mandibular Prognathism, Orthognathic Surgery
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.
Questions about this trial
What is this clinical trial studying?
A study testing customized fixation plate and maxillomandibular fixation in people with Mandibular Prognathism, 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 6 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 Feb 2019. 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?
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?
Patient Satisfaction (time frame: immediately postoperative). 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 26 Feb 2019; AzTrials last refreshed its copy on 1 Nov 2026.