VELOMEMBRANE: A New Membrane Obturator Prothesis Concept for Soft Palate Defects

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT04009811

Collaborator

(none)

Enrollment

Locations

Arms

23.5

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mouth Neoplasms Velopharyngeal Insufficiency Speech Disorders Deglutition Disorders	Device: Suersen and membraneous obturators evaluation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A New Membrane Obturator Prothesis Concept for Soft Palate Defects

Actual Study Start Date :

Jul 17, 2020

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Deglutition Handicap Index (DHI) overall score [Visit M1 : one month after inclusion]
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
Deglutition Handicap Index (DHI) overall score [Visit M2 : two months after inclusion]
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
Deglutition Handicap Index (DHI) overall score [Visit M3 : three months after inclusion]
Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
Health-related quality of life EORTC QLQ-C30 questionnaire score [Visit M1 : one month after inclusion]
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Health-related quality of life EORTC QLQ-C30 questionnaire score [Visit M2 : two months after inclusion]
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Health-related quality of life EORTC QLQ-C30 questionnaire score [Visit M3 : three months after inclusion]
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score [Visit M1 : one month after inclusion]
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score [Visit M2 : two months after inclusion]
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
Head and Neck quality of life EORTC QLQ-H&N35 questionnaire score [Visit M3 : three months after inclusion]
Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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