Comparison of Different Feeding Appliances for Cleft Palate Babies

Tanta University

Status: Completed

Conditions: Cleft Palate

Treatments: Device: flexible feeding plate

Study type: Interventional

Funder types: Other

Identifiers

NCT06103162

#R-RP-7-23-2

Details and patient eligibility

About

This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

Full description

This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

The purpose of the present study will be explained to the patient's parents and informed consent will be obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.

Enrollment: 30 patients

Sex: All

Ages: 1 to 15 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants with age range from 1-15 days.
• Unilateral cleft palate.
• Medically free subjects.
• Both males and females.

Exclusion criteria

• Patients older than 15 days.
• Syndromic patients with other defects in addition to cleft lip and palate.
• Patients with bilateral cleft lip and palate.
• Patients with previous presurgical infant orthopedic treatment.
• Medically compromised patients.-

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

group 1 rigid feeding plate

Active Comparator group

Description:

Heat cure polymerizing acrylic resin was used to fabricate the second appliance.

Treatment:

Device: flexible feeding plate

group 2 flexible feeding plate

Active Comparator group

Description:

One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.

Treatment:

Device: flexible feeding plate

special feeding appliance

Active Comparator group

Description:

special feeding bottle

Treatment:

Device: flexible feeding plate