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Purpose

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.

Condition

Eligibility

Eligible Ages
Under 6 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Retrospective Group(Control)
  • 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.
Experimental
Prospective Group
  • 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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Anh Tran, DDs
713-486-4150
Anh.T.Tran@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Ahn Tran, DDS
(713) 486-4150
Anh.T.Tran@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.