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

November 4, 2020 updated by: Anh T Tran, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs
Time Frame: initial time of examination with study team, time of surgery(3 months post intervention)
initial time of examination with study team, time of surgery(3 months post intervention)
Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs
Time Frame: initial time of examination with study team, time of surgery(3 months post intervention)
initial time of examination with study team, time of surgery(3 months post intervention)
Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs
Time Frame: initial time of examination with study team, time of surgery(3 months post intervention)
initial time of examination with study team, time of surgery(3 months post intervention)
Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs
Time Frame: initial time of examination with study team, time of surgery(3 months post intervention)
initial time of examination with study team, time of surgery(3 months post intervention)

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire
Time Frame: initial time of examination with study team
initial time of examination with study team
Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire
Time Frame: time of surgery(3 months post intervention)
time of surgery(3 months post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Ahn Tran, DDS, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-DB-20-0311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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