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Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches

24 participantsStarted 2023-08-01

Plain-language summary

The nasal deformity is an abnormality in the appearance and structure of the nose in cleft patients having unilateral cleft lip and palate (UCLP). It involves the displacement of the lower lateral nasal cartilage, oblique and short columella, depressed dome, overhanging nostril apex, and deviated septum. Difficulty in breathing and smelling are the main problems of this deformity. Rhinoplasty for CLP patients is very complicated due to the complex nature of this type of deformity, especially in wide and bilateral cleft patients it is quite challenging.

Who can participate

Age range1 Day – 1 Month

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants with 0 (after birth) to 1 month of age * Non-syndromic with no other medical conditions * Unilateral complete cleft lip and palate * Cleft width \> 5 mm Exclusion Criteria: * Syndromic UCLP or bilateral cleft lip and palate * Incomplete UCLP * Cleft width ≤ 5 mm

What they're measuring

Change in nasal tip projection

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

change in Columella height

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in projection alar length

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in width of the nostril

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in nasal basal width

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in the angle of the columella

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in cleft lip segment

Trial details

NCT IDNCT05940389

SponsorAl-Azhar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

Contact for this trial

Abdallah Bahaa, M.Sc.

01114084090 abdallahbahaa000@gmail.com

View on ClinicalTrials.gov More Unilateral Cleft Lip trials

Plain-language summary

Who can participate

Age range1 Day – 1 Month

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in nasal tip projection

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

change in Columella height

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in projection alar length

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in width of the nostril

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in nasal basal width

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in the angle of the columella

Timeframe: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Change in cleft lip segment