Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510881
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Single Stage Versus Multiple Staged Repair of Nasal Alveolar Deformities in Patients With Cleft Lip and Palate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single Stage Versus Multiple Staged Repair of Nasal Alveolar Deformities in Patients With Cleft Lip and Palate
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Patients complaints 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
Pre-operative evaluation
History taking
Personal history name age gender and occupation Patients complaints 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None