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Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate

NCT06510881 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-19

No results posted yet for this study

Summary

Cleft lip and palate patients are commonly seen among maxillofacial patients. Patients with cleft lip and palate have evident cosmetic nasal deformities. The interrupted insertion of orbicularis oris muscle into the columella on the noncleft side forces the premaxilla, columella and caudal nasal septum towards that side. At the same time, as the orbicularis oris inserts into the alar base on the cleft side, the base is pulled laterally, inferiorly and posteriorly. The malformed lower lateral cartilage on the side of the cleft contributes majorly to the deformity of the nasal tip, causing it to be more blunt. A shorter medial crus and longer lateral crus on the cleft side results in a horizontally wider and displaced nostril on the cleft side. In addition, those patients have alveolar bone defect which results in both cosmetic and dental problems. Repair of the deformed nose along with the reconstruction of the alveolar defect may have an advantage over the staged repair in:- decrease the surgical burden on the patient , correction of the facial asymmetry by redeeming the maxillary bony support , peri-alar augmentation and accordingly obtaining faster and better socio-cosmetic benefit .

Conditions

  • Cleft Lip and Palate
  • Rhinoplasty

Interventions

PROCEDURE

Rhinoplasty with or without cleft alveolus repair

* Group (A) : Correction of nasal deformity will be carried out using costochondral cartilage strut for support of septum and lengthening of columella . A concomitant iliac bone graft is taken to reconstruct the alveolar bone . This group age will be above 8 years . * Group (B) : Patients who present early before age of 8 years will have rhinoplasty session only . Another session will be prepared for cleft alveolus at age of 8 years .

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Salaheldin Shaltout, MD · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-20
Primary Completion
2026-02-20
Completion
2027-02-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510881 on ClinicalTrials.gov