DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants

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

  • Cleft Lip and Palate

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