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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04455035
Other study ID # HSC-DB-20-0311
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 21, 2020
Est. completion date June 1, 2021

Study information

Verified date November 2020
Source The University of Texas Health Science Center, Houston
Contact Ahn Tran, DDS
Phone (713) 486-4150
Email Anh.T.Tran@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility Inclusion Criteria: Retrospective Group: - 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: Retrospective Group: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Device:
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.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs initial time of examination with study team, time of surgery(3 months post intervention)
Primary Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs initial time of examination with study team, time of surgery(3 months post intervention)
Primary Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs initial time of examination with study team, time of surgery(3 months post intervention)
Primary Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs initial time of examination with study team, time of surgery(3 months post intervention)
Secondary Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire initial time of examination with study team
Secondary Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire time of surgery(3 months post intervention)
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