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NCT Number: NCT03284125

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

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 .

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Key information

Conditions

Peripheral Facial Paralysis Facial Paralysis Mouth Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de chirurgie maxillo-faciale, CHRU de TOURS

Tours, 37044, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swallowing disorders evaluation

Other

Self-administered questionnaires and non-invasive clinics tests

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: MATPF

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2017
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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