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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
Sponsor:
Information provided by (Responsible Party):
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 .


Condition or disease Intervention/treatment
Peripheral Facial Paralysis Other: Swallowing disorders evaluation

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Facial paralysis
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients affected by facial paralysis and treated by lenthening temporalis myoplasty
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Benjamin CROISE 02.47.47.89.54 ext +33 benjamin.croise.med@gmail.com
Contact: Boris LAURE, MD-PhD 02.47.47.89.54 ext +33 b.laure@chu-tours.fr

Locations
France
Service de chirurgie maxillo-faciale, CHRU de TOURS Recruiting
Tours, France, 37044
Contact: Benjamin CROISE    02.47.47.89.54 ext +33    benjamin.croise.med@gmail.com   
Principal Investigator: Boris Boris, MD-PhD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Boris LAURE, MD-PhD University Hospital, Tours

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03284125     History of Changes
Other Study ID Numbers: RIPH3-RNI17/MATPF
2017-A01577-46 ( Other Identifier: IdRCB )
2017-39 ( Other Identifier: CPP )
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Paralysis
Facial Paralysis
Bell Palsy
Facies
Deglutition Disorders
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases