Clinical Trial: Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligner

Brief Summary: Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.

Detailed Summary:

newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners.

the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.


Sponsor: Cairo University

Current Primary Outcome: Parents' satisfaction [ Time Frame: 3 months ]

It will be measured by questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in Nasal morphology( Height, width, angulation of columella [ Time Frame: 3 months ]
    It will be measured in mm by Standardized Digital photographs
  • Changes in Interlabial gab [ Time Frame: 3 months ]
    It will be measured in mm by Standardized Digital photographs
  • Changes in Maxillary arch dimension [ Time Frame: 3 months ]
    It will be measured in mm by Digital models


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: January 4, 2017
Date Started: January 2017
Date Completion: December 2017
Last Updated: April 22, 2017
Last Verified: April 2017