Treatment results of combined platelet-rich plasma and fat injection in patients with velopharyngeal insufficiency

Phase 2

• Conditions: Velopharyngeal insufficiency.; Unspecified soft tissue disorder related to use, overuse and pressure

• Registration Number: IRCT201306018435N5
• Lead Sponsor: Vice chancellor for research, Tehran University of Medical Sciences and Health Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients with repaired cleft palate; Patients aged 15-20 years;Patients with any defects in the pharyngeal wall area and volume;Patients undergoing injection of combined platelet-rich plasma and fat; Patients with mild to moderate velopharyngeal insufficiency confirmed by nasoendoscopy; signing consent to participate in the study.
Exclusion criteria: Neurological impairment ; Mental retardation; Tumor area velopharyngeal; Hearing loss; Presence of pharyngeal flap; Oronasal fistula;Large tonsils; Severe velopharyngeal insufficiency.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gap velopharyngeal. Timepoint: Before the injection, at 6 weeks and 6 months after the injection. Method of measurement: Nasal endoscopy video analysis.;Displacement of the soft palate. Timepoint: Before the injection, at 6 weeks and 6 months after the injection. Method of measurement: Nasal endoscopy video analysis.;Lateral and the posterior pharyngeal wall motion. Timepoint: Before the injection, at 6 weeks and 6 months after the injection. Method of measurement: Nasal endoscopy video analysis.;Hypernasal resonance. Timepoint: Before the injection, at 6 weeks and 6 months after the injection. Method of measurement: Repeat the words and phrases.;Nasal air escape. Timepoint: Before the injection, at 6 weeks and 6 months after the injection. Method of measurement: Repeat the words and phrases.;Intelligibility. Timepoint: Before the injection, at 6 weeks and 6 months after the injection. Method of measurement: Repeat the words and phrases.