Evaluation
Conditions
Keywords
nasoalveolar molding, digital nasoalveolar molding, complete unilateral cleft lip and palate
Brief summary
This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.
Detailed description
For this prospective study, twenty newborns with non-syndromic complete unilateral cleft lip and palate were referred from the Outpatient Clinics of several pediatric surgeons and obstetricians to the Department of Prosthodontics -Faculty of Dentistry - Tanta University. Inclusion criteria: * Age range from 2-3 weeks after birth. * Only the Non-syndromic unilateral cleft lip and palate neonates. * Newborn infants without any surgical intervention. Exclusion criteria: * Patients with the life threatening syndromes. * Respiratory difficulties are not considered for presurgical treatment. * Uncooperative guardians.
Interventions
DEVICEnasoalveolar molding appliance
making impression then make the conventional lab procedures for group A for the production of conventional appliances
DEVICEdigital nasoalveolar molding appliance
group B scanning the model and designing the appliances on 3shap and 3d printing the appliances
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
starting 2 conventional then 2 CAD NAM patients
Intervention model description
2 groups : Group A receiving conventional nasoalveolar molding appliance and Group B receiving CAD NAM
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 4 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Age range from 2-3 weeks after birth. * Only the Non-syndromic unilateral cleft lip and palate neonates. * Newborn infants without any surgical intervention.
Exclusion criteria
* Patients with the life threatening syndromes. * Respiratory difficulties are not considered for presurgical treatment. * Uncooperative guardians.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoral measurements | 3 -4 months | measuring 2 points the first is the intersegmental distance in (mm) and the second is the alveolar width in (mm) |
| extraoral measurements | 3-4 months | * Nostril height in (mm) * Nasal dome height in (mm) * Columella height in( mm) * Nostril basal width in (mm) * Nostril width in (mm) |
Countries
Egypt
Outcome results
None listed