Digital Impression in Neonates

NCT ID: NCT05929560

Last Updated: 2023-07-03

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-06-15

Brief Summary

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The goal of this \[clinical trial\] is to \[explore the attitudes of guardians with different educational background regarding the technique of impression registration as well as the compliance to using feeding appliances \] in \[neonates\].

Researchers will compare \[conventional impression technique to digital impression\]

Detailed Description

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Conditions

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Unilateral Complete Cleft Lip and Palate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Paired design "Same patients receive conventional impression and digital"
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional impression

Group Type ACTIVE_COMPARATOR

Conventional impression

Intervention Type OTHER

Palatal impressions obtained using an irreversible hydrocolloid impression material

Digital impression

Group Type EXPERIMENTAL

Digital impression

Intervention Type OTHER

after obtaining stone models from conventional impression material, stone models were scanned using the I700 (Medit) scanner and Patients were directly scanned intraorally using an intraoral 3D scanner Subsequently, the printed 3D model scan data of the seven patients were then used for standard triangulated language (STL)

Interventions

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Conventional impression

Palatal impressions obtained using an irreversible hydrocolloid impression material

Intervention Type OTHER

Digital impression

after obtaining stone models from conventional impression material, stone models were scanned using the I700 (Medit) scanner and Patients were directly scanned intraorally using an intraoral 3D scanner Subsequently, the printed 3D model scan data of the seven patients were then used for standard triangulated language (STL)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with unilateral complete cleft lip and palate
* neonates

Exclusion Criteria

* infants and children
* bilateral cleft lip and palatal
* incomplete cleft lip
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Digital_impression_neonates_23

Identifier Type: -

Identifier Source: org_study_id

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