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

NCT ID: NCT03284125

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-02

Study Completion Date

2018-06-12

Brief Summary

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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

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Conditions

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Peripheral Facial Paralysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Facial paralysis

Patients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery.

Swallowing disorders evaluation

Intervention Type OTHER

Self-administered questionnaires and non-invasive clinics tests

Interventions

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Swallowing disorders evaluation

Self-administered questionnaires and non-invasive clinics tests

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris LAURE, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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Service de chirurgie maxillo-faciale, CHRU de TOURS

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01577-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017-39

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH3-RNI17/MATPF

Identifier Type: -

Identifier Source: org_study_id

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