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

• Sponsor: Minia University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05837780
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 32.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Unilateral Cleft Lip and Palate	Other: Nasoalveolar molding device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jan 3, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: conventionally constructed nasoalveolar molding devices (control group) control group: patients receiving conventionally constructed nasoalveolar molding devices	Other: Nasoalveolar molding device; comparison between using conventionally and digitally constructed nasoalveolar molding devices
Experimental: Digitally constructed nasoalveolar molding devices (test group) test group: patients receiving digitally constructed nasoalveolar molding devices	Other: Nasoalveolar molding device; comparison between using conventionally and digitally constructed nasoalveolar molding devices

Outcome Measures

Primary Outcome Measures

1. Alveolar cleft width [3 months]

   measurement of width between two alveolar segments

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Days to 1 Month
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry ,Minya university	Minya		Egypt

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Doaa Tawfik Hassan, Lecturer of prosthodontics, Minia University
• ClinicalTrials.gov Identifier: NCT05837780
• Other Study ID Numbers: Clp04042024
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cleft Lip

Study Results

No Results Posted as of May 1, 2023