Completed

VELOMEMBRANEA New Membrane Obturator Prothesis Concept for Soft Palate Defects

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What is being tested

Suersen and membraneous obturators evaluation

Device
Who is being recruted

Congenital Abnormalities+22

+ Communication Disorders

+ Deglutition Disorders

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2020
See protocol details

Summary

Principal SponsorUniversity Hospital, Bordeaux
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 17, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleA New Membrane Obturator Prothesis Concept for Soft Palate Defects
NCT04009811
Principal SponsorUniversity Hospital, Bordeaux
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCommunication DisordersDeglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesHead and Neck NeoplasmsLanguage DisordersMouth AbnormalitiesStomatognathic DiseasesMouth DiseasesMouth NeoplasmsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SiteNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesPharyngeal DiseasesSigns and SymptomsSpeech DisordersPathological Conditions, Signs and SymptomsVelopharyngeal InsufficiencyStomatognathic System AbnormalitiesNeurobehavioral Manifestations

Criteria

7 inclusion criteria required to participate
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)

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9 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

CHU de Bordeaux

Bordeaux, FranceOpen CHU de Bordeaux in Google Maps
CompletedOne Study Center
VELOMEMBRANE | A New Membrane Obturator Prothesis Concept for Soft Palate Defects | PatLynk