NCT05837780

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

April 20, 2023

Last Update Submit

July 21, 2024

Conditions

Unilateral Cleft Lip and Palate

Outcome Measures

Primary Outcomes (1)

  • Alveolar cleft width

    measurement of width between two alveolar segments

    3 months

Study Arms (2)

conventionally constructed nasoalveolar molding devices (control group)

EXPERIMENTAL

control group: patients receiving conventionally constructed nasoalveolar molding devices

Other: Nasoalveolar molding device

Digitally constructed nasoalveolar molding devices (test group)

EXPERIMENTAL

test group: patients receiving digitally constructed nasoalveolar molding devices

Other: Nasoalveolar molding device

Interventions

Nasoalveolar molding deviceOTHER

comparison between using conventionally and digitally constructed nasoalveolar molding devices

Digitally constructed nasoalveolar molding devices (test group)conventionally constructed nasoalveolar molding devices (control group)

Eligibility Criteria

Age7 Days - 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry ,Minya university

Minya, Egypt

Location

MeSH Terms

Interventions

Palatal Obturators

Intervention Hierarchy (Ancestors)

Dental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant Lecturer of prosthodontics

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 1, 2023

Study Start

January 3, 2023

Primary Completion

January 1, 2025

Study Completion

October 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations

EG(1)