A New Membrane Obturator Prothesis Concept for Soft Palate Defects

Deglutition Disorders Clinical Trial

— VELOMEMBRANE  

Official title:

A New Membrane Obturator Prothesis Concept for Soft Palate Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009811
• Other study ID #: CHUBX 2018/34
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: February 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 15, 2022
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Disease
• Mouth Neoplasms
• Speech Disorders
• Velopharyngeal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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