Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate
July 18, 2024 updated by: Youssef Saleh, Assiut University
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 .
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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) :
- Having a blocked or obstructed nose
- Getting air through my nose during exercise
- Having a congested nose
- Breathing through my nose during sleep
- Decreased mood and self-esteem due to my nose
- The shape of my nasal tip
- The straightness of my nose
- The shape of my nose from the side
- How well my nose suits my face
- 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 .
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohammed Ramadan, Master
- Phone Number: 01024529525
- Email: mhmdrmdn1994@gmail.com
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Assiut University
-
Contact:
- Assiut university Hospital
- Phone Number: +2088241-1906
- Email: irbasyut@aun.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Patients at or above age of 8 years for combined rhinoplasty and alveolar repair
|
|
|
Experimental: Group B
patients below 8 years for rhinoplasty alone and a planned alveolar repair in an upcoming session before canine eruption .
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 .
Time Frame: 6 months after surgery
|
|
6 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Salaheldin Shaltout, MD, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 20, 2024
Primary Completion (Estimated)
February 20, 2026
Study Completion (Estimated)
February 20, 2027
Study Registration Dates
First Submitted
July 15, 2024
First Submitted That Met QC Criteria
July 18, 2024
First Posted (Actual)
July 19, 2024
Study Record Updates
Last Update Posted (Actual)
July 19, 2024
Last Update Submitted That Met QC Criteria
July 18, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Post cleft rhinoplasty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.