Cleft Lip and Palate
Conditions
Brief summary
This randomized trial is designed to assess the effectiveness of nasal elevator as a presurgical infant orthopedics on improvement of nose esthetics vs taping alone.
Interventions
DEVICENasal Elevator
A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.
DEVICETaping Alone
Horizontal tape alone.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
Yes
Inclusion criteria
* Infants with age range from 1-30 days. * Unilateral complete cleft lip and alveolus. * Medically free subjects. * Both males and females. * Cleft gap more than 10 mm.
Exclusion criteria
* Patients older than 30 days. * Syndromic patients with other defects in addition to cleft lip and palate. * Patients with bilateral cleft lip and palate. * Incomplete Cleft lip. * Patient with previous surgical lip repair or adhesion. * Patients with previous presurgical infant orthopedic treatment. * Medically compromised patients. * Cleft gap distance less than 10mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Esthetics | 3 months | Nasal esthetics will be following Dr Farkas' measurements and it will be carried out as linear and angular measurements on standardized photographs. it will be measured using photoshop software. |
| Maxillary arch changes | 3 months | Different maxillary arch dimensions (e.g. cleft and arch widths and symmetry) will be measured virtually on digital models in mm using 3shape software. |
Countries
Egypt
Outcome results
None listed