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

Unilateral Cleft Lip and Palate Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05837780
• Other study ID #: Clp04042024
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: October 2025

Study information

• Verified date: April 2023
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: October 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Days to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Unilateral Cleft Lip and Palate

Intervention

Other:
• Nasoalveolar molding device
comparison between using conventionally and digitally constructed nasoalveolar molding devices

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry ,Minya university	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar cleft width	measurement of width between two alveolar segments	3 months