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Prospective Group for Cleft Lip and Palate

N/A
Recruiting
Led By Ahn Tran, DDS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral cleft lip with or without cleft palate
Patients of a single surgeon (Matthew Greives, MD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of surgery(3 months post intervention)
Awards & highlights

Study Summary

This trial will compare outcomes of infants who had the DynaCleft® system to those who had traditional treatment for cleft lip.

Eligible Conditions
  • Cleft Lip and Palate

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of surgery(3 months post intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of surgery(3 months post intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs
Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs
Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs
+1 more
Secondary outcome measures
Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective GroupExperimental Treatment1 Intervention
Group II: Retrospective Group(Control)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,894 Total Patients Enrolled
3 Trials studying Cleft Lip and Palate
115 Patients Enrolled for Cleft Lip and Palate
Ahn Tran, DDSPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025