Cleft Lip and Palate
Conditions
Brief summary
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.
Detailed description
newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.
Interventions
DEVICEVacuum formed aligners
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.
Sponsors
Cairo University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 3 Months
Healthy volunteers
Yes
Inclusion criteria
* Non-syndromic Infants with complete unilateral cleft lip and palate * Infants less than 3 months of age * Males and females. * Infants with displaced alveolus * Patients whose parents provided written consent for the study.
Exclusion criteria
* Patients above 3 months of age * Syndromic, malnourished and systemically ill infants. * Patients with bilateral cleft lip and palate. * Incomplete Cleft lip. * Medically compromised patients * Patient's/guardians who will be unwilling to go through the PNAM therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parents' satisfaction | 3 months | It will be measured by questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Nasal morphology( Height, width, angulation of columella | 3 months | It will be measured in mm by Standardized Digital photographs |
| Changes in Interlabial gab | 3 months | It will be measured in mm by Standardized Digital photographs |
| Changes in Maxillary arch dimension | 3 months | It will be measured in mm by Digital models |
Contacts
Primary ContactKhadega Ali Al Khateeb, Master
Outcome results
None listed