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

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04455035
• Other study ID #: HSC-DB-20-0311
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: November 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: Ahn Tran, DDS
• Phone: (713) 486-4150
• Email: Anh.T.Tran[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs		initial time of examination with study team, time of surgery(3 months post intervention)
Primary	Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs		initial time of examination with study team, time of surgery(3 months post intervention)
Primary	Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs		initial time of examination with study team, time of surgery(3 months post intervention)
Primary	Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs		initial time of examination with study team, time of surgery(3 months post intervention)
Secondary	Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire		initial time of examination with study team
Secondary	Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire		time of surgery(3 months post intervention)