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AzTrials

Mouth NeoplasmsVELOMEMBRANENCT04009811

A New Membrane Obturator Prothesis Concept for Soft Palate Defects

A study testing Suersen and membraneous obturators evaluation in people with Mouth Neoplasms and Velopharyngeal Insufficiency, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Suersen and membraneous obturators evaluation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteFrance
Study dates
17 Jul 2020to 15 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Pregnant or lactating woman
  • Participation in another interventional study
  • Inability to give informed consent

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Bordeaux

    Bordeaux, 33076

Other trials in France

About this study

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.

Read the 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 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.

Being tested
Suersen and membraneous obturators evaluation
Keywords
Randomized controlled trial, Palatal obturators
Medical subject headings
Mouth Neoplasms, Velopharyngeal Insufficiency, Speech Disorders, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suersen and membraneous obturators evaluationDevice

    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.

Study groups in NCT04009811
Study groupRoleWhat they receive
Suersen obturator then membraneous obturatorExperimentalNot described
Receives: Device: Suersen and membraneous obturators evaluation
Membraneous obturator then Suersen obturatorExperimentalNot described
Receives: Device: Suersen and membraneous obturators evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Voice Handicap Index (VHI) overall score

    Min : 0 = Non handicap to Max : 120 = voice handicap maximum

    Measured: Visit M2 : one month after first obturator supply i.e. two months after inclusion

  2. Voice Handicap Index (VHI) overall score

    Min : 0 = Non handicap to Max : 120 = voice handicap maximum

    Measured: Visit M3 : one month after second obturator supply i.e. three months after inclusion

Secondary outcomes (9)

  1. Deglutition Handicap Index (DHI) overall score

    Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum

    Measured: Visit M1 : one month after inclusion

  2. Deglutition Handicap Index (DHI) overall score

    Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum

    Measured: Visit M2 : two months after inclusion

  3. Deglutition Handicap Index (DHI) overall score

    Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum

    Measured: Visit M3 : three months after inclusion

  4. Health-related quality of life EORTC QLQ-C30 questionnaire score

    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

    Measured: Visit M1 : one month after inclusion

  5. Health-related quality of life EORTC QLQ-C30 questionnaire score

    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

    Measured: Visit M2 : two months after inclusion

  6. Health-related quality of life EORTC QLQ-C30 questionnaire score

    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

    Measured: Visit M3 : three months after inclusion

  7. Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score

    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

    Measured: Visit M1 : one month after inclusion

  8. Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score

    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

    Measured: Visit M2 : two months after inclusion

  9. Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score

    Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

    Measured: Visit M3 : three months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start17 Jul 2020
  3. Primary completion10 Apr 2022
  4. Study completion15 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009811
Sponsor's protocol ID
CHUBX 2018/34
Acronym
VELOMEMBRANE
Status last verified
Feb 2023
First submitted
24 Jun 2019
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Naveau 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.

    PubMed 35303932

Questions about this trial

What is this clinical trial studying?

A study testing Suersen and membraneous obturators evaluation in people with Mouth Neoplasms and Velopharyngeal Insufficiency, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Voice Handicap Index (VHI) overall score (time frame: Visit M2 : one month after first obturator supply i.e. two months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009811, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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