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Trial record 19 of 365 for:    "Speech Disorder"

A New Membrane Obturator Prothesis Concept for Soft Palate Defects (VELOMEMBRANE)

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ClinicalTrials.gov Identifier: NCT04009811
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
When soft palate defects lead to palatal insufficiency, the patient's quality of life is affected by difficulties swallowing, hypernasality, and poor intelligibility of speech. If immediate surgical reconstruction is not an option, the patient may benefit from the placement of a rigid obturator prosthesis. Unfortunately, the residual muscle stumps are often unable to adequately move this stiff and inert obturator to properly restore the velopharyngeal valve function. The objective of this case report was to describe the use of a membrane obturator prosthesis that incorporates a dental dam to compensate for the soft palate defect.

Condition or disease Intervention/treatment Phase
Mouth Neoplasms Velopharyngeal Insufficiency Speech Disorders Deglutition Disorders Device: Suersen and membraneous obturators evaluation Not Applicable

Detailed Description:

The velopharyngeal sphincter seals the oropharynx from the nasopharynx during swallowing and speech. This three-dimensional muscular valve closes through the synergistic behavior of the soft palate and the lateral and posterior walls of the pharynx. A soft palate defect surgically acquired in the context of oral cancer may impede complete closure and lead to a palatopharyngeal insufficiency. The resultant airflow escape results in hypernasality, poor speech intelligibility, and swallowing problems (such as leakage of foods and fluids into the nasal airways). The best way to rehabilitate and restore chewing and swallowing is one of the top ten research priorities in head and neck cancer. When the velopharyngeal function cannot be immediately restored with surgical reconstruction, patients can benefit from an obturator prosthesis. This obturator is a rigid extension of acrylic resin positioned at the level of the hard palate that provides surface contact for the remaining musculature. Often, the residual muscle stumps cannot move adequately around this stiff and inert obturator to properly restore the velopharyngeal valve function. The resulting blockage, or free space between the tissues and obturator, is a main cause of prosthetic failure. Subsequently, in many cases, oral functions remain impaired, with a negative impact on the patient's quality of life.

The compensating treatment consists of a provisional removable partial denture (RPD) with a membrane obturator. The membrane consisted of a thick dental dam shaped with scissors to create a 10-mm overlap with the pharyngeal walls that was then perforated with four holes using punch pliers.

The follow-up ends after the last visit. However, our team can provide cares of any patient seeking for dental care, prosthetic treatments and routine follow-up.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A New Membrane Obturator Prothesis Concept for Soft Palate Defects
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Suersen obturator then membraneous obturator Device: Suersen and membraneous obturators evaluation

The patient will wear one month each obturator prothesis (Suersen and membraneous obturators). The order of evaluation will be randomized in two arms.

Half of patient will first wear one month the membranous obturator then one month the Suersen, the other half of patient will first wear one month the Suersen obturator and one month the membranous obturator.


Experimental: Membraneous obturator then Suersen obturator Device: Suersen and membraneous obturators evaluation

The patient will wear one month each obturator prothesis (Suersen and membraneous obturators). The order of evaluation will be randomized in two arms.

Half of patient will first wear one month the membranous obturator then one month the Suersen, the other half of patient will first wear one month the Suersen obturator and one month the membranous obturator.





Primary Outcome Measures :
  1. Voice Handicap Index (VHI) overall score [ Time Frame: Visit M2 : one month after first obturator supply i.e. two months after inclusion ]
    Min : 0 = Non handicap to Max : 120 = voice handicap maximum

  2. Voice Handicap Index (VHI) overall score [ Time Frame: Visit M3 : one month after second obturator supply i.e. three months after inclusion ]
    Min : 0 = Non handicap to Max : 120 = voice handicap maximum


Secondary Outcome Measures :
  1. Deglutition Handicap Index (DHI) overall score [ Time Frame: Visit M1 : one month after inclusion ]
    Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum

  2. Deglutition Handicap Index (DHI) overall score [ Time Frame: Visit M2 : two months after inclusion ]
    Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum

  3. Deglutition Handicap Index (DHI) overall score [ Time Frame: Visit M3 : three months after inclusion ]
    Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum

  4. Health-related quality of life EORTC QLQ-C30 questionnaire score [ Time Frame: Visit M1 : one month after inclusion ]
    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

  5. Health-related quality of life EORTC QLQ-C30 questionnaire score [ Time Frame: Visit M2 : two months after inclusion ]
    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

  6. Health-related quality of life EORTC QLQ-C30 questionnaire score [ Time Frame: Visit M3 : three months after inclusion ]
    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

  7. Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score [ Time Frame: Visit M1 : one month after inclusion ]
    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

  8. Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score [ Time Frame: Visit M2 : two months after inclusion ]
    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

  9. Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score [ Time Frame: Visit M3 : three months after inclusion ]
    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult over 18 year-old
  • Acquired loss of velar or palato-velar substance (maxillectomies of Class I and II a-d, Brown 2010) following the excision of a tumor
  • Indication of Suersen obturator prosthesis rehabilitation
  • Possible dental rehabilitation with removable prosthesis (retention and stability prosthetic provided without the use of glue, mouth opening allowing fingerprints, presence of saliva, dexterity allowing the insertion and removal of prostheses, as well as the cleaning of devices)
  • Having given their consent to participate in the study
  • Speaking French, knowing how to read it
  • Available and motivated for regular follow-up during the study period

Exclusion Criteria:

  • Child under 18
  • Allergy to acrylic resin
  • Radiotherapy or chemotherapy in progress
  • Surgery of the veil programmed during the 3 months necessary for the realization and the wearing of the prostheses.
  • Loss of congenital or traumatic palato-velar substance
  • Maxillectomies including orbital floor or total maxillectomy
  • Pregnant or lactating woman
  • Participation in another interventional study
  • Inability to give informed consent

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): NCT04009811


Contacts
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Contact: Adrien NAVEAU, DDS 05 57 62 34 34 ext +33 adrien.naveau@chu-bordeaux.fr
Contact: Olivier DELORME 05 57 82 01 34 ext +33 olivier.delorme@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Adrien NAVEAU, DDS    05 57 62 34 34 ext +33    adrien.naveau@chu-bordeaux.fr   
Contact: Olivier DELORME    05 57 82 01 34 ext +33    olivier.delorme@chu-bordeaux.fr   
Principal Investigator: Adrien NAVEAU, DDS         
CHU de Toulouse Not yet recruiting
Toulouse, France, 31400
Contact: Florent DESTRUHAUT, DDS       destruhautflorent@yahoo.fr   
Principal Investigator: Florent DESTRUHAUT, DDS         
Sub-Investigator: Caroline DE BATAILLE, DDS         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Elise ARRIVE, DDS Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04009811     History of Changes
Other Study ID Numbers: CHUBX 2018/34
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University Hospital, Bordeaux:
Randomized controlled trial
Palatal obturators

Additional relevant MeSH terms:
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Speech Disorders
Disease
Deglutition Disorders
Mouth Neoplasms
Velopharyngeal Insufficiency
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities