An interventional study of Rhinoplasty with or without cleft alveolus repair in Cleft Lip and Palate and Rhinoplasty, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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 .
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) :
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.
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 .
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 116 interventional studies indexed under Cleft Lip.
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Exclusion Criteria:
* Patients with bilateral complete cleft palate .
Patients at or above age of 8 years for combined rhinoplasty and alveolar repair
Procedure: Rhinoplasty with or without cleft alveolus repair
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
* 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 .
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
Time frame: 6 months after surgery
Plan to share: Yes
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