An interventional study of Suersen and membraneous obturators evaluation in Mouth Neoplasms, Velopharyngeal Insufficiency and Speech Disorders, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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.
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.
446 studies on the registry are indexed under Mouth Neoplasms; 130 are open to participants now.
This study's enrollment of 4 is below the median of 60 across 313 interventional studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Suersen and membraneous obturators evaluation
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.
Voice Handicap Index (VHI) overall score
Min : 0 = Non handicap to Max : 120 = voice handicap maximum
Time frame: Visit M2 : one month after first obturator supply i.e. two months after inclusion
Voice Handicap Index (VHI) overall score
Min : 0 = Non handicap to Max : 120 = voice handicap maximum
Time frame: Visit M3 : one month after second obturator supply i.e. three months after inclusion
Deglutition Handicap Index (DHI) overall score
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
Time frame: Visit M1 : one month after inclusion
Deglutition Handicap Index (DHI) overall score
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
Time frame: Visit M2 : two months after inclusion
Deglutition Handicap Index (DHI) overall score
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
Time frame: Visit M3 : three months after inclusion
Health-related quality of life EORTC QLQ-C30 questionnaire score
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Time frame: Visit M1 : one month after inclusion
Health-related quality of life EORTC QLQ-C30 questionnaire score
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Time frame: Visit M2 : two months after inclusion
Health-related quality of life EORTC QLQ-C30 questionnaire score
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Time frame: Visit M3 : three months after inclusion
Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Time frame: Visit M1 : one month after inclusion
Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Time frame: Visit M2 : two months after inclusion
Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Time frame: Visit M3 : three months after inclusion
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Bordeaux →