Effect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients

Minia University

Status: Invitation-only

Conditions: Unilateral Cleft Lip and Palate

Treatments: Other: Nasoalveolar molding device

Study type: Interventional

Funder types: Other

Identifiers

NCT05837780

Clp04042024

Details and patient eligibility

About

This study includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device

Enrollment: 36 estimated patients

Sex: All

Ages: 7 days to 1 month old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent

Exclusion criteria

• Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

conventionally constructed nasoalveolar molding devices (control group)

Experimental group

Description:

control group: patients receiving conventionally constructed nasoalveolar molding devices

Treatment:

Other: Nasoalveolar molding device

Digitally constructed nasoalveolar molding devices (test group)

Experimental group

Description:

test group: patients receiving digitally constructed nasoalveolar molding devices

Treatment:

Other: Nasoalveolar molding device