Effect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients

NCT ID: NCT05837780

Last Updated: 2024-07-23

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2025-10-31

Brief Summary

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This study includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device

Detailed Description

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Conditions

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Unilateral Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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conventionally constructed nasoalveolar molding devices (control group)

control group: patients receiving conventionally constructed nasoalveolar molding devices

Group Type EXPERIMENTAL

Nasoalveolar molding device

Intervention Type OTHER

comparison between using conventionally and digitally constructed nasoalveolar molding devices

Digitally constructed nasoalveolar molding devices (test group)

test group: patients receiving digitally constructed nasoalveolar molding devices

Group Type EXPERIMENTAL

Nasoalveolar molding device

Intervention Type OTHER

comparison between using conventionally and digitally constructed nasoalveolar molding devices

Interventions

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Nasoalveolar molding device

comparison between using conventionally and digitally constructed nasoalveolar molding devices

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent

Exclusion Criteria

* Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent
Minimum Eligible Age

7 Days

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Amany Alaa Abd el Aziz

assistant Lecturer of prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry ,Minya university

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Clp04042024

Identifier Type: -

Identifier Source: org_study_id

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