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

NCT06510881 | Recruiting

• 1 other identifier: Post cleft rhinoplasty
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Evaluation of SCHNOS criteria in both groups for evaluation of both cosmetic and functional improvement . The patients will be assessed on the scale and compared between the obtained pre and post operative results after 6 months of surgery .

  1. Having a blocked or obstructed nose 2. Getting air through my nose during exercise 3. Having a congested nose 4. Breathing through my nose during sleep 5. Decreased mood and self-esteem due to my nose 6. The shape of my nasal tip 7. The straightness of my nose 8. The shape of my nose from the side 9. How well my nose suits my face 10. The overall symmetry of my nose

  6 months after surgery

Study Arms (2)

Group A

EXPERIMENTAL

Patients at or above age of 8 years for combined rhinoplasty and alveolar repair

Procedure: Rhinoplasty with or without cleft alveolus repair

Group B

EXPERIMENTAL

patients below 8 years for rhinoplasty alone and a planned alveolar repair in an upcoming session before canine eruption .

Procedure: Rhinoplasty with or without cleft alveolus repair

Interventions

Rhinoplasty with or without cleft alveolus repair PROCEDURE

* 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 .

Group A; Group B

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Patients with unilateral cleft lip and palate deformities with evident nasal and cleft lip and palate aged between 5 - 18 years.

You may not qualify if:

• \* Patients with bilateral complete cleft palate .
• Patients with only cleft lip.
• Patients with cleft secondary palate.
• Patients non fit for surgery.
• Patients refuse the consent.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Related Publications (6)

• DeVictor SR, Tollefson TT. Rhinoplasty in Patients with Cleft Lip Nasal Deformity: Correcting the Alar Base. Facial Plast Surg. 2023 Dec;39(6):668-673. doi: 10.1055/a-2127-3665. Epub 2023 Jul 11.

  PMID: 37433309 BACKGROUND

• Phillips S, Hauc SC, Sasson DC, Khetpal S, Ihnat JM, Boroumand S, Rodriguez J, Prassinos A, Lopez J, Steinbacher DM. Sociodemographic Disparities in Access to Cleft Rhinoplasty. J Craniofac Surg. 2023 Jan-Feb 01;34(1):92-95. doi: 10.1097/SCS.0000000000008908. Epub 2022 Aug 17.

  PMID: 35973113 RESULT

• Balaji SM. Cleft Rhinoplasty- Columellar lengthening prolabial reconstruction with Abbe flap. Ann Maxillofac Surg. 2016 Jan-Jun;6(1):63-7. doi: 10.4103/2231-0746.186146.

  PMID: 27563610 RESULT

• Fisher DM. Unilateral cleft lip repair: an anatomical subunit approximation technique. Plast Reconstr Surg. 2005 Jul;116(1):61-71. doi: 10.1097/01.prs.0000169693.87591.9b.

  PMID: 15988248 RESULT

• Patil PG, Nimbalkar-Patil SP. Modified Activation Technique for Nasal Stent of Nasoalveolar Molding Appliance for Columellar Lengthening in Bilateral Cleft Lip/Palate. J Prosthodont. 2018 Jan;27(1):94-97. doi: 10.1111/jopr.12464. Epub 2016 Mar 22.

  PMID: 27002917 RESULT

• Liao D, Pereira N, Obayemi A Jr, Sclafani AP. Secondary Cleft Rhinoplasty. Facial Plast Surg Clin North Am. 2024 Feb;32(1):43-54. doi: 10.1016/j.fsc.2023.06.003. Epub 2023 Jul 26.

  PMID: 37981415 RESULT

MeSH Terms

Conditions

Cleft Lip

Interventions

Rhinoplasty

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Nasal Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Salaheldin Shaltout, MD

  Assiut University

  STUDY CHAIR

Central Study Contacts

Mohammed Ramadan, Master

CONTACT

01024529525; mhmdrmdn1994@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: July 20, 2024
• Primary Completion: February 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)