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
NCT ID: NCT03011489
Last Updated: 2017-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
14 participants
INTERVENTIONAL
2017-01-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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.
control group
This group will not receive any treatment
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Infants less than 3 months of age
* Males and females.
* Infants with displaced alveolus
* Patients whose parents provided written consent for the study.
Exclusion Criteria
* Syndromic, malnourished and systemically ill infants.
* Patients with bilateral cleft lip and palate.
* Incomplete Cleft lip.
* Medically compromised patients
* Patient's/guardians who will be unwilling to go through the PNAM therapy
1 Week
3 Months
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Khadega Ali Al Khateeb
Master student, faculty of oral and dental medicine, Cairo university
Principal Investigators
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Fatma Abdu Abdelsayed, professor
Role: STUDY_DIRECTOR
Cairo University
Central Contacts
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Other Identifiers
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UCLP_Vacuum
Identifier Type: -
Identifier Source: org_study_id
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