Clinical trial · Interventional
A New Membrane Obturator Prothesis Concept for Soft Palate Defects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deglutition Disorders | — | UNRESOLVED | — |
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
| Speech Disorders | — | UNRESOLVED | — |
| Velopharyngeal Insufficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Suersen and membraneous obturators evaluation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Suersen obturator then membraneous obturator
- interventionNames
- Device: Suersen and membraneous obturators evaluation
- type
- EXPERIMENTAL
- label
- Membraneous obturator then Suersen obturator
- interventionNames
- Device: Suersen and membraneous obturators evaluation
Primary outcomes (2)
- measure
- Voice Handicap Index (VHI) overall score
- timeFrame
- Visit M2 : one month after first obturator supply i.e. two months after inclusion
- description
- Min : 0 = Non handicap to Max : 120 = voice handicap maximum
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNaveau A, Kret M, Plaire V, Delorme O, Marchi S, de Bataille C, Destruhaut F, Arrive E, Bou C. Efficacy of a new membrane obturator prosthesis in terms of speech, swallowing, and the quality of life of patients with acquired soft palate defects: study protocol of the VELOMEMBRANE randomized crossover trial. Trials. 2022 Mar 18;23(1):221. doi: 10.1186/s13063-022-06163-6. PMID 35303932