Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis

Completed

• Conditions: Peripheral Facial Paralysis
• Interventions: Other: Swallowing disorders evaluation

• Registration Number: NCT03284125
• Lead Sponsor: University Hospital, Tours

Brief Summary

The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.

This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-02
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-15
• Primary Completion: 2018-06-12
• Study Completion: 2018-06-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Chronic peripheral facial paralysis
• Freyss score inferior at 15
• Benefiting of a lengthening temporalis myoplasty

Exclusion Criteria

• Malformative syndrome
• Other swallowing trouble
• Psychiatric trouble
• Opposed at this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Facial paralysis	Swallowing disorders evaluation	Patients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery.

Primary Outcome Measures

Name	Time	Method
Change from baseline lips pressure at 6 months	Baseline, 3 and 6 months	Patients must contracted their lips of the paretic side in a manometer to evaluate the pressure of the lips before surgery and at 3 and 6 months after

Secondary Outcome Measures

Name	Time	Method
Drooling Severity and Frequency Scale (DSFS)	Baseline, 3 and 6 months	The Drooling Score equals the sum of the Severity and Frequency sub-scores. the severity sub scores contains five items ( 1= never, 2= mild drooling, 3= moderate drool, 4= severe drool, 5= profuse drool) The frequency sub score contains four items ( 1= no drooling, 2= occasionally, 3=frequently, 4= constant drooling)
Dysphagia handicap index (DHI)	Baseline, 3 and 6 months	This self-administered questionnaire allows to evaluate 3 types of handicap (physical, functional and social) It contains 30 questions and the maximum score is 120 (0= never, 1= almost never, 2= occasionally, 3= almost always, 4= always)
Visual scale of food residue	Baseline, 3 and 6 months	Patients must eat a melba toast on paretic side and after we evaluate the food residue before surgery and at 3 and 6 months after

Trial Locations

Locations (1)

Service de chirurgie maxillo-faciale, CHRU de TOURS; 🇫🇷 Tours, France