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NCT Number: NCT06852196

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

orthognathic surgery ,lefort 1,bsso ,DO

Procedure

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 osteogenesis

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. facial canons

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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