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

NCT ID: NCT06852196

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-21

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Maxillary Hypoplasia Cleft Lip Palate Orthognathic Surgery

Keywords

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cleft maxillary hypoplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery first

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

Group Type EXPERIMENTAL

orthognathic surgery ,lefort 1,bsso ,DO

Intervention Type 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

Intervention Type PROCEDURE

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

othodontics first

orthodontics first then surgery

Group Type EXPERIMENTAL

orthognathic surgery ,lefort 1,bsso ,DO

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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orthognathic 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

Intervention Type PROCEDURE

distraction osteogenesis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdullah Hashim Ahmed

Assistant lecturer of plastic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Cleft Maxillary Hypoplasia

Identifier Type: -

Identifier Source: org_study_id