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NCT Number: NCT06510881

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

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 .

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Rhinoplasty Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

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 .

    Time frame: 6 months after surgery

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Ramadan, Master

CONTACT

[email protected]

01024529525

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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