Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.

NCT ID: NCT06211205

Last Updated: 2024-01-18

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2025-06-30

Brief Summary

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Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.

The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.

Detailed Description

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Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Customized nostril retainer combined with lip taping

Group Type EXPERIMENTAL

Customized 3D printed nostril retainer combined with lip taping

Intervention Type DEVICE

the infants will receive a customised nostril retainer appliance to enhance the nasal esthetics combined with lip tape to approximate the labial and alveolar segments

Lip taping

Group Type ACTIVE_COMPARATOR

Lip taping

Intervention Type PROCEDURE

the infants will receive lip tape to approximate the labial and alveolar segments

Interventions

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Customized 3D printed nostril retainer combined with lip taping

the infants will receive a customised nostril retainer appliance to enhance the nasal esthetics combined with lip tape to approximate the labial and alveolar segments

Intervention Type DEVICE

Lip taping

the infants will receive lip tape to approximate the labial and alveolar segments

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Infants with age range from 1-30 days.
2. Unilateral complete cleft lip and palate
3. Medically free subjects.
4. Both males and females.

Exclusion Criteria

1. Patients older than 30 days.
2. Syndromic patients with other defects in addition to cleft lip and palate.
3. Patients with bilateral cleft lip and palate.
4. Incomplete cleft lip.
5. Patient with previous surgical lip repair or adhesion.
6. Patients with previous presurgical infant orthopedic treatment.
7. Medically compromised patients.
Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hana Adel Adawy

Hana Adawy, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Orthodontics, Faculty of Dentistry, Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hana A Adawy

Role: CONTACT

+201002061202

Facility Contacts

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Hana A Adawy

Role: primary

+01002061202

Other Identifiers

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NCT26091993123

Identifier Type: -

Identifier Source: org_study_id

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