A New Membrane Obturator Prothesis Concept for Soft Palate Defects (NCT04009811) | Clinical Trial Compass
CompletedNot Applicable
A New Membrane Obturator Prothesis Concept for Soft Palate Defects
France4 participantsStarted 2020-07-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Voice Handicap Index (VHI) overall score
Timeframe: Visit M2 : one month after first obturator supply i.e. two months after inclusion
2
Voice Handicap Index (VHI) overall score
Timeframe: Visit M3 : one month after second obturator supply i.e. three months after inclusion