Comparison of Different Feeding Appliances for Cleft Palate Babies

NCT ID: NCT06103162

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-10-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Cleft Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1 rigid feeding plate

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

Group Type ACTIVE_COMPARATOR

flexible feeding plate

Intervention Type DEVICE

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

group 2 flexible feeding plate

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

Group Type ACTIVE_COMPARATOR

flexible feeding plate

Intervention Type DEVICE

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

special feeding appliance

special feeding bottle

Group Type ACTIVE_COMPARATOR

flexible feeding plate

Intervention Type DEVICE

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

Interventions

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flexible feeding plate

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

Intervention Type DEVICE

Other Intervention Names

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special feeding appliance

Eligibility Criteria

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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.-
Minimum Eligible Age

1 Day

Maximum Eligible Age

15 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Amel Salem

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amel AE salem

Role: PRINCIPAL_INVESTIGATOR

faculty of dentistry tanta university

Locations

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faculty of dentistry Tanta University

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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#R-RP-7-23-2

Identifier Type: -

Identifier Source: org_study_id

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