Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis (MATPF)
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|ClinicalTrials.gov Identifier: NCT03284125|
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : October 27, 2017
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 .
|Condition or disease||Intervention/treatment|
|Peripheral Facial Paralysis||Other: Swallowing disorders evaluation|
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis|
|Actual Study Start Date :||September 2, 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Patients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery.
Other: Swallowing disorders evaluation
Self-administered questionnaires and non-invasive clinics tests
- Change from baseline lips pressure at 6 months [ Time Frame: 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
- Drooling Severity and Frequency Scale (DSFS) [ Time Frame: 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)
- Visual scale of food residue [ Time Frame: 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
- Dysphagia handicap index (DHI) [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284125
|Contact: Benjamin CROISE||02.47.47.89.54 ext +firstname.lastname@example.org|
|Contact: Boris LAURE, MD-PhD||02.47.47.89.54 ext +email@example.com|
|Service de chirurgie maxillo-faciale, CHRU de TOURS||Recruiting|
|Tours, France, 37044|
|Contact: Benjamin CROISE 02.47.47.89.54 ext +33 firstname.lastname@example.org|
|Principal Investigator: Boris Boris, MD-PhD|
|Principal Investigator:||Boris LAURE, MD-PhD||University Hospital, Tours|