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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03284125
Acronym
MATPF
Enrollment
13
Registered
2017-09-15
Start date
2017-09-02
Completion date
2018-06-12
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Facial Paralysis

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 .

Interventions

OTHERSwallowing disorders evaluation

Self-administered questionnaires and non-invasive clinics tests

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline lips pressure at 6 monthsBaseline, 3 and 6 monthsPatients 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

MeasureTime frameDescription
Drooling Severity and Frequency Scale (DSFS)Baseline, 3 and 6 monthsThe 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 residueBaseline, 3 and 6 monthsPatients 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)Baseline, 3 and 6 monthsThis 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026