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

NCT ID: NCT06510881

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2027-02-20

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 .

Detailed Description

Patients are assigned randomly into two groups; group (1) for combined rhinoplasty and alveolar repair , and group (2) for alveolar repair alone and a planned rhinoplasty in an upcoming session .

Pre-operative evaluation:

History taking:

Personal history; name, age, gender and occupation . Patient's complaint(s); as dental problems related to cleft alveolus and both cosmetic and obstructive problems related to nasal deformities .

Clinical examination :

Dental assessment and assessment of the nose according to the Final Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS criteria) :

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

Radiological evaluation:

Computed Tomography (CT) scan of maxillofacial bones .

Laboratory investigations:

Blood picture, coagulation profile, kidney and liver function tests .

Photogrammetric evaluation

Standard facial photographs of the basal view taken before and after operation will be used to evaluate the results. The photos will evaluate : alar base , nasal tip and nasolabial angle .

Operative procedures:

will be carried out by the same team, under general anesthesia, nasotracheal intubation and supine position.

• Group (1) : Correction of nasal deformity will be carried out according to the pattern of deformity and the complaint of the patient as : cartilage strut for septal support and columellar lengthening , repositioning the alar bases or reconstructing the nasal muscular ring . A concomitant iliac bone graft is taken to reconstruct the alveolar bone .
• Group (2) : Patients will have their alveolus repaired . Bone grafting will be done . Another session will be prepared after 6 months for the rhinoplasty session . The same technique regarding iliac bone graft will be done for those patients .

Post-operative :

Patients will be counselled for wound care , oral hygiene and medications as : Antibiotics , analgesics and anti-inflammatory drugs . Functional and cosmetic outcomes will be assessed 6 months postoperatively .

Conditions

Cleft Lip and Palate; Rhinoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Rhinoplasty with or without cleft alveolus repair

Intervention Type: 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 B

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

Group Type: EXPERIMENTAL

Rhinoplasty with or without cleft alveolus repair

Intervention Type: 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 .

Interventions

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 .

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• * 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Youssef Saleh

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salaheldin Shaltout, MD

Role: STUDY_CHAIR

Assiut University

Locations

Assiut university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammed Ramadan, Master

Role: CONTACT

mhmdrmdn1994@gmail.com

01024529525

Facility Contacts

Assiut university Hospital

Role: primary

irbasyut@aun.edu.eg

+2088241-1906

References

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.

Reference Type: BACKGROUND

PMID: 37433309 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35973113 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27563610 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15988248 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27002917 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37981415 (View on PubMed)

Other Identifiers

Post cleft rhinoplasty

Identifier Type: -

Identifier Source: org_study_id