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
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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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-01-30
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Customized nostril retainer combined with lip taping
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
Lip taping
Lip taping
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
Lip taping
the infants will receive lip tape to approximate the labial and alveolar segments
Eligibility Criteria
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Inclusion Criteria
2. Unilateral complete cleft lip and palate
3. Medically free subjects.
4. Both males and females.
Exclusion Criteria
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.
30 Days
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Hana Adel Adawy
Hana Adawy, Principal Investigator
Locations
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Department of Orthodontics, Faculty of Dentistry, Cairo university
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCT26091993123
Identifier Type: -
Identifier Source: org_study_id
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