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Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

Recruiting
1 - 1 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  1. Non-Syndromic infants with complete bilateral cleft lip and palate.
  2. Both sexes.
  3. Age range from 1-30 day

Exclusion Criteria:

  1. Infants with systemic syndromes.
  2. infants with unilateral cleft
  3. infants whom parents refuse to consent.

Study details

Cleft Lip and Palate

NCT05796336

University of Baghdad

13 April 2024

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