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

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: Terminated
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Other: Comparator: Retrospective Group(Control); Device: Prospective Group

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Measure Description	Time Frame
Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs	Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.	initial time of examination with study team, time of surgery (3 months post intervention)
Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs	Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination.	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	Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.	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	Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.	initial time of examination with study team, time of surgery (3 months post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Number of Responses Indicating Improvement, no Change, or Decrease in Quality of Life as Assessed by the Infant and New Parent Quality of Life Questionnaire	The Infant and New Parent Quality of Life questionnaire consists of 22 questions related to quality of life. For each question, it was determined whether the response at 3 months indicated an improvement, no change, or a decrease in quality of life relative to the response at the time of initial examination. The average number with an improvement in quality of life (averaged over all 22 questions), the average number who had no change in quality of life (averaged over all 22 questions), and the average number who had a decrease in quality of life (averaged over all 22 questions) are reported.	initial time of examination with study team, time of surgery (3 months post intervention)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Brett T Chiquet, DDS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): April 6, 2021
• Study Completion (Actual): April 6, 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Dynacleft
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Cleft Lip
• 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