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CompletedNCT03284125MATPFUpdated Apr 28, 2021

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

An observational study in Peripheral Facial Paralysis, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by University Hospital, Tours · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13
Ages
6 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Facial Paralysis with a site in France — 5 open to participants now, 5 under way, none of them phase 3. Facial Paralysis · France.

Started
2017
with 2 others
Observational
2 of 14
1 open now
Registered
5th of 14
by date
Lead sponsor
1 of 14
University Hospital, Tours

Among the 14 studies in Facial Paralysis with a site in France, this one is one of 3 that started in 2017, is one of 2 observational ones, and was the 5th registered.

Facial Paralysis

81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.

Browse Facial Paralysis studies →

Open to participants now

5 of the 14 studies in Facial Paralysis with a site in France are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 19 Facial Paralysis studies recruiting now, 7 (37%) set no upper age limit and 9 (47%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 6 Years and older · all sexes · no healthy volunteers.

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02

Study 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 .

03

Conditions studied

  • Peripheral Facial Paralysis

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04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients affected by facial paralysis and treated by lenthening temporalis myoplasty

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic peripheral facial paralysis
  • Freyss score inferior at 15
  • Benefiting of a lengthening temporalis myoplasty

Exclusion criteria

Exclusion Criteria:

  • Malformative syndrome
  • Other swallowing trouble
  • Psychiatric trouble
  • Opposed at this study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherSwallowing disorders evaluation

    Self-administered questionnaires and non-invasive clinics tests

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, 3 and 6 months

Secondary outcomes

  1. 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)

    Time frame: Baseline, 3 and 6 months

  2. 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

    Time frame: Baseline, 3 and 6 months

  3. 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)

    Time frame: Baseline, 3 and 6 months

07

Study locations

1 site
  • Service de chirurgie maxillo-faciale, CHRU de TOURS
    Tours, 37044, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Jun 2018, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2017
First posted
Sep 15, 2017
StartActual
Sep 2, 2017
Primary completionActual
Jun 12, 2018
CompletionActual
Jun 12, 2018
Last update
Apr 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03284125
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Sep 2, 2017
Primary completion
Jun 12, 2018
Completion
Jun 12, 2018
Last update
Apr 28, 2021

Study contacts

Boris LAURE, MD-PhD
principal investigator · University Hospital, Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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