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

Peripheral Facial Paralysis Clinical Trial

— MATPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284125
• Other study ID #: RIPH3-RNI17/MATPF
• Secondary ID: 2017-A01577-4620
• Status: Completed
• Start date: September 2, 2017
• Est. completion date: June 12, 2018

Study information

• Verified date: April 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Deglutition Disorders
• Facial Paralysis
• Facies
• Paralysis
• Peripheral Facial Paralysis

Intervention

Other:
• Swallowing disorders evaluation
Self-administered questionnaires and non-invasive clinics tests

Locations

Country	Name	City	State
France	Service de chirurgie maxillo-faciale, CHRU de TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline lips pressure at 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	Baseline, 3 and 6 months
Secondary	Drooling Severity and Frequency Scale (DSFS)	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)	Baseline, 3 and 6 months
Secondary	Visual scale of food residue	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	Baseline, 3 and 6 months
Secondary	Dysphagia handicap index (DHI)	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)	Baseline, 3 and 6 months