NCT05535530

The Effect of a Newly Designed Presurgical Orthopedic Appliance

The Effect of a Newly Designed Presurgical Orthopedic Appliance on Maxillary Arch Dimensions in Infants With Bilateral Cleft Lip and Palate: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 5 Days – 2 Months
• Healthy volunteers: Accepted

Summary

A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

Detailed description

It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used, and group two a new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Conditions

• Cleft Lip and Palate

Interventions

Type	Name	Description
DEVICE	Active PSIO	new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-08-15
• Completion: 2022-09-01
• First posted: 2022-09-10
• Last updated: 2022-09-21

Locations

1 site across 1 country: Iraq