- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009811
A New Membrane Obturator Prothesis Concept for Soft Palate Defects (VELOMEMBRANE)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33076
- CHU de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Suersen obturator then membraneous obturator
|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Visit M2 : one month after first obturator supply i.e. two months after inclusion
|
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
|
Visit M3 : one month after second obturator supply i.e. three months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Deglutition Handicap Index (DHI) overall score
Time Frame: Visit M1 : one month after inclusion
|
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
|
Visit M1 : one month after inclusion
|
Deglutition Handicap Index (DHI) overall score
Time Frame: Visit M2 : two months after inclusion
|
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
|
Visit M2 : two months after inclusion
|
Deglutition Handicap Index (DHI) overall score
Time Frame: Visit M3 : three months after inclusion
|
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
|
Visit M3 : three months after inclusion
|
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
|
Visit M1 : one month after inclusion
|
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
|
Visit M2 : two months after inclusion
|
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
|
Visit M3 : three months after inclusion
|
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
|
Visit M1 : one month after inclusion
|
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
|
Visit M2 : two months after inclusion
|
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
|
Visit M3 : three months after inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Elise ARRIVE, DDS, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Esophageal Diseases
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Language Disorders
- Communication Disorders
- Disease
- Deglutition Disorders
- Mouth Neoplasms
- Speech Disorders
- Velopharyngeal Insufficiency
Other Study ID Numbers
- CHUBX 2018/34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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