Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function

Alexandria University

Status: Completed

Conditions: Cleft Lip and Palate

Treatments: Device: Feeding appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT06075069

#111

Details and patient eligibility

About

Aim of the study was to evaluate the effect of feeding appliance for congenital cleft lip and palate infants on the middle ear function

Enrollment: 30 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants with bilateral cleft lip and palate.
• Centralized pre-maxilla that does not need active appliance.
• Normal inner ear and auditory nerve function.

Exclusion criteria

• Infant with unilateral cleft lip and palate or cleft palate only.
• Deviated pre-maxilla that needs active appliance.
• Congenital hearing problems or sensorineural hearing loss/

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Feeding appliance immediately after birth

Experimental group

Treatment:

Device: Feeding appliance

Feeding appliance after 1-3 months

Experimental group

Treatment:

Device: Feeding appliance

Feeding appliance after 4 -12 months

Experimental group

Treatment:

Device: Feeding appliance