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.

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: A Randomized Clinical Trial.

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06211205

Enrollment

Registered

2024-01-18

Start date

2024-01-30

Completion date

2025-06-30

Last updated

2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Brief summary

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.

Interventions

DEVICECustomized 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

PROCEDURELip taping

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 30 Days

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Nasolabial esthetics	3 months	Nasal basal width, Collumella Length, Defetcted Nostril width and height, Interlabial gap will be measured in mm at 2 time points to evaluate the effect of the intervention. This will be performed on a 3D scan for the infants and through calibrated photographs

Secondary

Measure	Time frame	Description
Maxillary arch changes	3 months	Interalveolar gap will be measured in mm through an intraoral scan for the infants at 2 time points

Countries

Egypt

Contacts

Primary ContactHana A Adawy

hana_adel@dentistry.cu.edu.eg+201002061202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026