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
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|ClinicalTrials.gov Identifier: NCT03011489|
Recruitment Status : Unknown
Verified April 2017 by Khadega Ali Al Khateeb, Cairo University.
Recruitment status was: Not yet recruiting
First Posted : January 5, 2017
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cleft Lip and Palate||Device: Vacuum formed aligners||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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 Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Vacuum formed aligners group
This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks
Device: Vacuum formed aligners
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.
No Intervention: control group
This group will not receive any treatment
- Parents' satisfaction [ Time Frame: 3 months ]It will be measured by questionnaire
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011489
|Contact: Khadega Ali Al Khateeb, Masterfirstname.lastname@example.org|
|Study Director:||Fatma Abdu Abdelsayed, professor||Cairo University|