NCT05796336

Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

Effectiveness of Two Methods of Lip Taping as a Presurgical Orthopedic in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 1 Day – 1 Month
• Healthy volunteers: Accepted

Summary

A randomized clinical trial to compare the effectiveness of two methods of lip taping as a 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 with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping 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	Lip taping	Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. 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: 2023-01-12
• Primary completion: 2024-03-01
• Completion: 2024-05-01
• First posted: 2023-04-03
• Last updated: 2024-04-08

Locations

1 site across 1 country: Iraq