Mandibular DeficiencyNCT06850194
Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy
A study testing vertical ramus osteotomy with iliac graft and bilateral sagittal splitting osteotomy in people with Mandibular Deficiency, run by Fayoum University at 1 site in Egypt.
Trial summary
Patients will be collected from faculty of dentistry bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO All patients will be studied by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Deficiency
- What is being tested?
- vertical ramus osteotomy with iliac graft and bilateral sagittal splitting osteotomy
- 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
- 15 Feb 2025to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with age above 18 years old suffered from skeletal class II with severe mandibular deficiency
Who cannot join
- patients with chin deviation,
- severe temporomandibular joint (TMJ) symptoms.
- Sever periodontal disease
- pregnancy,
- previous mandibular surgery,
- inability to follow-up for the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suief University
Beni-seuf, Egypt, 02
shaimaa m refahee, 0201227407987, smr11@fayoum.edu.eg
About this study
Official title: Evaluating the Efficacy of Vertical Ramus Osteotomy With Iliac Graft Versus Bilateral Sagittal Split Osteotomy for the Correction of Mandibular Deficiency in Skeletal Class II Cases Management. A Randomized Controlled Trial
- Patients will be collected from faculty of dentistry
- bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or
- bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO
- All patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (T0), immediately after the surgery (T1), and 6 months after surgery (T2).
- All lateral cephalometric radiographs and clinical photographs must be standardized for all cases.
- After pre-surgical orthodontic treatment , a lateral cephalograph Will be obtained for planning the surgical movement of both jaws
- Surgical models and surgical stent will be fabricated.
- All surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard LeFort I setback fosteotomy; the BSSO group will be underwent BSSO, and VRO group will be underwent VRO
- The bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )
- Conditions
- Mandibular Deficiency
- Being tested
- vertical ramus osteotomy with iliac graft, bilateral sagittal splitting osteotomy
- Medical subject headings
- Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertical ramus osteotomy with iliac graftProcedure or surgery
in the VRO group all patient will undergo vertical ramus osteotomy surgery with iliac graft to correct the sever mandibular defficiency
bilateral sagittal splitting osteotomyProcedure or surgery
all patients in this group will undergo to bilateral sagittal split osteotomy to correct the sever mandibular deficiency
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Sagittal Split Osteotomy Group | Active comparator | Not described Receives: Procedure: bilateral sagittal splitting osteotomy |
| vertical ramus osteotomy with iliac graft group | Experimental | Not described Receives: Procedure: vertical ramus osteotomy with iliac graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal stability
Skeletal stability will be assessed by lateral cephalometric x-ray. It will be done pre operatively, immediate postoperative, and 6 months later
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular DeficiencyStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850194
- Sponsor's protocol ID
- 111
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Vertical Ramus Osteotomy With Iliac Graft Versus Bilateral Sagittal Split Osteotomy for the Correction of Mandibular Deficiency in Skeletal Class II Cases Management. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06850194
- Acronym / sponsor ID
- 111
- Conditions
- Mandibular Deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 27 Feb 2025 (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.
- Patients will be collected from faculty of dentistry
- bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or
- bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO
- All patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (T0), immediately after the surgery (T1), and 6 months after surgery (T2).
- All lateral cephalometric radiographs and clinical photographs must be standardized for all cases.
- After pre-surgical orthodontic treatment , a lateral cephalograph Will be obtained for planning the surgical movement of both jaws
- Surgical models and surgical stent will be fabricated.
- All surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard LeFort I setback fosteotomy; the BSSO group will be underwent BSSO, and VRO group will be underwent VRO
- The bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Sagittal Split Osteotomy Group | Active comparator | Procedure: bilateral sagittal splitting osteotomy |
| vertical ramus osteotomy with iliac graft group | Experimental | Procedure: vertical ramus osteotomy with iliac graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with age above 18 years old suffered from skeletal class II with severe mandibular deficiency
Key exclusion criteria (6 listed)
- patients with chin deviation,
- severe temporomandibular joint (TMJ) symptoms.
- Sever periodontal disease
- pregnancy,
- previous mandibular surgery,
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 |
|---|---|---|
| vertical ramus osteotomy with iliac graftin the VRO group all patient will undergo vertical ramus osteotomy surgery with iliac graft to correct the sever mandibular defficiency | Procedure or surgery | vertical ramus osteotomy with iliac graft group |
| bilateral sagittal splitting osteotomyall patients in this group will undergo to bilateral sagittal split osteotomy to correct the sever mandibular deficiency | Procedure or surgery | Bilateral Sagittal Split Osteotomy Group |
Primary outcome
skeletal stability
Time frame: 6 months
Skeletal stability will be assessed by lateral cephalometric x-ray. It will be done pre operatively, immediate postoperative, and 6 months later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vertical ramus osteotomy with iliac graft and bilateral sagittal splitting osteotomy in people with Mandibular Deficiency, run by Fayoum 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal stability (time frame: 6 months). 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 28 Feb 2025.