CHU de Bordeaux
Bordeaux, 33076, France
NCT Number: NCT04009811
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bordeaux, 33076, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
Time frame: Visit M1 : one month after inclusion
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
Time frame: Visit M2 : two months after inclusion
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
Time frame: Visit M3 : three months after inclusion
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
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
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
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
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
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
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
University Hospital, Bordeaux
Other
Acronym: VELOMEMBRANE
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