Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches

Tanta University

Status: Completed

Conditions: Evaluation

Treatments: Device: digital nasoalveolar molding appliance; Device: nasoalveolar molding appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT06522217

RP-12-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 2 to 4 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Conventional Group A

Active Comparator group

Description:

10 neonates receiving conventional nasoalveolar molding appliances

Treatment:

Device: nasoalveolar molding appliance

Digital Group B

Active Comparator group

Description:

10 neonates receiving CAD- nasoalveolar molding appliances

Treatment:

Device: digital nasoalveolar molding appliance