Comparison of Different Feeding Appliances for Cleft Palate Babies

Not Applicable

Completed

• Conditions: Cleft Palate
• Interventions: Device: flexible feeding plate

• Registration Number: NCT06103162
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-07-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-15
• Study Completion: 2023-10-16
• Study First Submitted QC: 2023-10-21
• Last Update Submitted: 2023-10-21
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1 rigid feeding plate	flexible feeding plate	Heat cure polymerizing acrylic resin was used to fabricate the second appliance.
group 2 flexible feeding plate	flexible feeding plate	One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
special feeding appliance	flexible feeding plate	special feeding bottle

Primary Outcome Measures

Name	Time	Method
The feeding efficiency	during 1 month	The measure was defined as the volume of fluid transferred per unit time, in milliliters per minute (mL/min).

Trial Locations

Locations (1)

faculty of dentistry Tanta University; 🇪🇬 Tanta, Egypt