DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
NCT ID: NCT04455035
Last Updated: 2024-12-30
Study Results
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View full resultsBasic Information
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TERMINATED
NA
24 participants
INTERVENTIONAL
2020-09-21
2021-04-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Retrospective Group(Control)
Comparator: Retrospective Group(Control)
The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.
Prospective Group
Prospective Group
The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.
DynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.
Linear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.
Interventions
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Comparator: Retrospective Group(Control)
The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.
Prospective Group
The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.
DynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.
Linear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.
Eligibility Criteria
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Inclusion Criteria
* Unilateral cleft lip with or without cleft palate
* Patients of a single surgeon (Matthew Greives, MD)
* Patients with complete photographs:
* After birth, first visit
* At cleft lip repair (3-4 months)
* Post-operative cleft repair (about 1 year of age)
Prospective Group:
* Patients with incomplete unilateral cleft lip with or without cleft palate
* Patients of any surgeon
Exclusion Criteria
* Bilateral cleft lip or complete unilateral cleft lip
* Patients operated on by other primary surgeons
* Patients with incomplete photo records will be evaluated to determine if the patient should be excluded
Prospective Group:
* Patients with bilateral cleft lip or complete unilateral cleft lip
* Patients whose parents refuse to consent to inclusion
* Patients with tape allergies to the adhesive of the DynaCleft®
* Patients with syndromic craniofacial conditions or Tessier type facial clefts
6 Months
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Brett Thomas Chiquet
Associate Professor
Principal Investigators
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Brett T Chiquet, DDS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-DB-20-0311
Identifier Type: -
Identifier Source: org_study_id