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Not yet recruitingNCT06852196Updated Feb 28, 2025

Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia

An interventional study of orthognathic surgery ,lefort 1,bsso ,DO and distraction osteogenesis in Maxillary Hypoplasia, Cleft Lip Palate and Orthognathic Surgery, sponsored by Assiut University. Not yet recruiting. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
12 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Maxillary Hypoplasia
  • Cleft Lip Palate
  • Orthognathic Surgery

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Keywords

  • cleft maxillary hypoplasia
03

In context

Retrognathia

62 studies on the registry are indexed under Retrognathia; 15 are open to participants now.

This study's planned enrollment of 22 is below the median of 34 across 52 interventional studies indexed under Retrognathia.

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Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cleft patients either cleft alveolus or cleft alveolus and palate.
  • Surgically fit patients.
  • Patients ready for orthognathic assessment undergoing either surgical or orthodontics correction.

Exclusion criteria

Exclusion Criteria:

  • 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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    surgery first

    modern surgery-first orthognathic surgery approach (reduced treatment time, efficient tooth decompensation, and early improvement in facial esthetics),

    Procedure: orthognathic surgery ,lefort 1,bsso ,DO · Procedure: distraction osteogenesis

  • Experimental
    othodontics first

    orthodontics first then surgery

    Procedure: orthognathic surgery ,lefort 1,bsso ,DO · Procedure: distraction osteogenesis

Interventions

  • Procedureorthognathic surgery ,lefort 1,bsso ,DO

    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

  • Proceduredistraction osteogenesis

    Distraction osteogenesis is a surgical technique that uses body's own repairing mechanisms for optimal reconstruction of the tissues.

06

What researchers measure

Primary outcomes

  1. CEPHALOMETRIC

    MAXILLARY COMPONENT SNA (degrees) Sella to Nasion to point A angle normal angle is 82 degree plus or minus 3 degree

    Time frame: 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

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06852196
Lead sponsor
Assiut University
Responsible party
Abdullah Hashim Ahmed (Assistant lecturer of plastic surgery, Assiut University) — Principal investigator
First posted
Feb 28, 2025
Start date
Feb 21, 2025 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Feb 28, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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