Comparison of Different Feeding Appliances for Cleft Palate Babies

October 21, 2023 updated by: Amel Salem, Tanta University
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, +2
        • faculty of dentistry Tanta university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1 rigid feeding plate
Heat cure polymerizing acrylic resin was used to fabricate the second appliance.
Device: flexible feeding plate
One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
Other Names:
  • special feeding appliance
Active Comparator: group 2 flexible feeding plate
One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
Device: flexible feeding plate
One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
Other Names:
  • special feeding appliance
Active Comparator: special feeding appliance
special feeding bottle
Device: flexible feeding plate
One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
Other Names:
  • special feeding appliance

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Amel AE salem, faculty of dentistry Tanta university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

October 16, 2023

Study Registration Dates

First Submitted

October 15, 2023

First Submitted That Met QC Criteria

October 21, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 21, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #R-RP-7-23-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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