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

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.

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.

Inclusion Criteria:

• 1. Healthy new born infants with complete bilateral cleft lip, alveolus and palate.

  2. Non-syndromic. 3. Non-operated cases.

Exclusion Criteria:

• 1. Infants with systemic syndromes. 2.Facial deformities.