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

NCT04455035 | Terminated Results FDA Device

• 1 other identifier: HSC-DB-20-0311
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dynacleft

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

  initial time of examination with study team, time of surgery (3 months post intervention)

Study Arms (2)

Retrospective Group(Control)

ACTIVE COMPARATOR

Other: Comparator: Retrospective Group(Control)

Prospective Group

EXPERIMENTAL

Device: Prospective Group

Interventions

Comparator: Retrospective Group(Control) OTHER

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.

Retrospective Group(Control)

Prospective Group DEVICE

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.

Prospective Group

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 with tape allergies to the adhesive of the DynaCleft®
• Patients with syndromic craniofacial conditions or Tessier type facial clefts

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Brett Chiquet, DDS, PhD, Associate Professor
• Organization: The University of Texas Health Science Center at Houston

Brett.T.Chiquet@uth.tmc.edu

7135008220

Study Officials

• Brett T Chiquet, DDS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 2, 2020
• Study Start: September 21, 2020
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: December 30, 2024
• Results First Posted: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)