A New Membrane Obturator Prothesis Concept for Soft Palate Defects (VELOMEMBRANE)

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.

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders; Speech Disorders; Mouth Neoplasms; Velopharyngeal Insufficiency
• Intervention / Treatment: Device: Suersen and membraneous obturators evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suersen obturator then membraneous obturator	Device: Suersen and membraneous obturators evaluation; 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.
Experimental: Membraneous obturator then Suersen obturator	Device: Suersen and membraneous obturators evaluation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voice Handicap Index (VHI) overall score	Min : 0 = Non handicap to Max : 120 = voice handicap maximum	Visit M2 : one month after first obturator supply i.e. two months after inclusion
Voice Handicap Index (VHI) overall score	Min : 0 = Non handicap to Max : 120 = voice handicap maximum	Visit M3 : one month after second obturator supply i.e. three months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deglutition Handicap Index (DHI) overall score	Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum	Visit M1 : one month after inclusion
Deglutition Handicap Index (DHI) overall score	Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum	Visit M2 : two months after inclusion
Deglutition Handicap Index (DHI) overall score	Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum	Visit M3 : three months after inclusion
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	Visit M1 : one month after inclusion
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	Visit M2 : two months after inclusion
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	Visit M3 : three months after inclusion
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	Visit M1 : one month after inclusion
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	Visit M2 : two months after inclusion
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	Visit M3 : three months after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Elise ARRIVE, DDS, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): April 10, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Palatal obturators
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Gastrointestinal Diseases; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Esophageal Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Language Disorders; Communication Disorders; Disease; Deglutition Disorders; Mouth Neoplasms; Speech Disorders; Velopharyngeal Insufficiency
• Other Study ID Numbers: CHUBX 2018/34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No