Maxillary HypoplasiaNCT06852196
Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia
A study testing orthognathic surgery ,lefort 1,bsso ,DO and distraction osteogenesis in people with Maxillary Hypoplasia and Cleft Lip Palate, run by Assiut University.
Trial summary
Maxillary hypoplasia in CLP deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from CLP repair.Turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related… Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Maxillary Hypoplasia, Cleft Lip Palate, Orthognathic Surgery
- What is being tested?
- orthognathic surgery ,lefort 1,bsso ,DO and distraction osteogenesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2025to 1 Dec 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cleft patients either cleft alveolus or cleft alveolus and palate.
- Surgically fit patients.
- Patients ready for orthognathic assessment undergoing either surgical or orthodontics correction.
Who cannot join
- Non- cleft cases .
- Previous correction.
- History of active infection or underlying disease such as hematologic disorders neoplasm, and immune deficiency.
- Patient refused to sign an informed consent.
About this study
Maxillary hypoplasia in CLP deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from CLP repair.Turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related to the congenital cleft deformity, Midfacial hypoplasia is commonly treated by performing conventional Le Fort surgery to displace the maxilla anteriorly and stabilization afterward with rigid fixation along with orthodontics treatment. .
Midface hypoplasia cleft patient has the following characteristics: concave facial profile, inverted nasal tip, wide alar base, acute nasolabial angle, and excessive exposure of sclera. Intraoral findings are anterior and posterior crossbite, CLP, accentuated curve of Spee, Class III dental malocclusion, multiple missing teeth, oronasal communication, and residual cleft. Speech disturbances are also usually present due to velopharyngeal incompetency and oronasal communication.
- Conditions
- Maxillary Hypoplasia, Cleft Lip Palate, Orthognathic Surgery
- Being tested
- orthognathic surgery ,lefort 1,bsso ,DO, distraction osteogenesis
- Keywords
- cleft maxillary hypoplasia
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthognathic surgery ,lefort 1,bsso ,DOProcedure or surgery
Le Fort I osteotomy is often used in the correction of dental occlusion and maxillary hypoplasia in cleft patients. In addition, the osteotomy may also improve patients' facial appearance and self-esteem
distraction osteogenesisProcedure or surgery
Distraction osteogenesis is a surgical technique that uses body's own repairing mechanisms for optimal reconstruction of the tissues.
| Study group | Role | What they receive |
|---|---|---|
| surgery first | Experimental | modern surgery-first orthognathic surgery approach (reduced treatment time, efficient tooth decompensation, and early improvement in facial esthetics), Receives: Procedure: orthognathic surgery ,lefort 1,bsso ,DO; Procedure: distraction osteogenesis |
| othodontics first | Experimental | orthodontics first then surgery Receives: Procedure: orthognathic surgery ,lefort 1,bsso ,DO; Procedure: distraction osteogenesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEPHALOMETRIC
MAXILLARY COMPONENT SNA (degrees) Sella to Nasion to point A angle normal angle is 82 degree plus or minus 3 degree
Measured: 1 year
Secondary outcomes (1)
facial canons
the rule of fifths, which divides the face in the transverse dimension into five equal parts by assuming that the intercanthal distance is equal to the nasal width and widths of the eyes, incorporates orbital and orbito-nasal canons
and three equal lengths of the face (the forehead, the nose, and the mouth and chin), as well as the intercanthal distance being equal to the eye fissure length measurement are in cm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start21 Feb 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary HypoplasiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Hashim Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852196
- Sponsor's protocol ID
- Cleft Maxillary Hypoplasia
- Status last verified
- Feb 2025
- First submitted
- 10 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
- Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia
- ClinicalTrials.gov ID
- NCT06852196
- Acronym / sponsor ID
- Cleft Maxillary Hypoplasia
- Conditions
- Maxillary Hypoplasia, Cleft Lip Palate, Orthognathic Surgery
- Keywords
- cleft maxillary hypoplasia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Feb 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 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.
Maxillary hypoplasia in CLP deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from CLP repair.Turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related to the congenital cleft deformity, Midfacial hypoplasia is commonly treated by performing conventional Le Fort surgery to displace the maxilla anteriorly and stabilization afterward with rigid fixation along with orthodontics treatment. .
Midface hypoplasia cleft patient has the following characteristics: concave facial profile, inverted nasal tip, wide alar base, acute nasolabial angle, and excessive exposure of sclera. Intraoral findings are anterior and posterior crossbite, CLP, accentuated curve of Spee, Class III dental malocclusion, multiple missing teeth, oronasal communication, and residual cleft. Speech disturbances are also usually present due to velopharyngeal incompetency and oronasal communication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery first | Experimental | Procedure: orthognathic surgery ,lefort 1,bsso ,DO, Procedure: distraction osteogenesismodern surgery-first orthognathic surgery approach (reduced treatment time, efficient tooth decompensation, and early improvement in facial esthetics), |
| othodontics first | Experimental | Procedure: orthognathic surgery ,lefort 1,bsso ,DO, Procedure: distraction osteogenesisorthodontics first then surgery |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Cleft patients either cleft alveolus or cleft alveolus and palate.
- Surgically fit patients.
- Patients ready for orthognathic assessment undergoing either surgical or orthodontics correction.
Key exclusion criteria (4 listed)
- Non- cleft cases .
- Previous correction.
- History of active infection or underlying disease such as hematologic disorders neoplasm, and immune deficiency.
- Patient refused to sign an informed consent.
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 |
|---|---|---|
| orthognathic surgery ,lefort 1,bsso ,DOLe Fort I osteotomy is often used in the correction of dental occlusion and maxillary hypoplasia in cleft patients. In addition, the osteotomy may also improve patients' facial appearance and self-esteem | Procedure or surgery | othodontics first, surgery first |
| distraction osteogenesisDistraction osteogenesis is a surgical technique that uses body's own repairing mechanisms for optimal reconstruction of the tissues. | Procedure or surgery | othodontics first, surgery first |
Primary outcome
CEPHALOMETRIC
Time frame: 1 year
MAXILLARY COMPONENT SNA (degrees) Sella to Nasion to point A angle normal angle is 82 degree plus or minus 3 degree
1 secondary outcome
facial canons
Time frame: 1 year
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.
Related trials for Maxillary Hypoplasia
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
Recruiting
Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery
Maxillary Deficiency, Bone Resorption
Recruiting
3D Printed Reverse Twin Block for Class III Malocclusion
Class III Malocclusion
Recruiting
Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.
Posterior Crossbite, Maxilla; Hypoplasia
Recruiting
Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment
Dental Malocclusion, Maxillary Deficiency
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.
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 orthognathic surgery ,lefort 1,bsso ,DO and distraction osteogenesis in people with Maxillary Hypoplasia and Cleft Lip Palate, run by Assiut 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 3 inclusion and 4 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: opening soon, 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.
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?
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?
CEPHALOMETRIC (time frame: 1 year). 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.