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

NCT04455035 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-30

Study results available
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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.

Conditions

  • Cleft Lip and Palate

Interventions

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Brett T Chiquet, DDS · The University of Texas Health Science Center, Houston

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2021-04-06
Completion
2021-04-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04455035 on ClinicalTrials.gov