Status:
COMPLETED
A New Membrane Obturator Prothesis Concept for Soft Palate Defects
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Mouth Neoplasms
Velopharyngeal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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 r...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04009811
Start Date
July 17 2020
End Date
July 15 2022
Last Update
February 24 2023
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France, 33076