A New Membrane Obturator Prothesis Concept for Soft Palate Defects

NCT04009811 | Completed

• 1 other identifier: CHUBX 2018/34
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Mouth Neoplasms; Velopharyngeal Insufficiency; Speech Disorders; Deglutition Disorders

Keywords

Randomized controlled trial; Palatal obturators

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Deglutition Handicap Index (DHI) overall score

  Visit M1 : one month after inclusion

• Deglutition Handicap Index (DHI) overall score

  Visit M2 : two months after inclusion

• Deglutition Handicap Index (DHI) overall score

  Visit M3 : three months after inclusion

• Health-related quality of life EORTC QLQ-C30 questionnaire score

  Visit M1 : one month after inclusion

• Health-related quality of life EORTC QLQ-C30 questionnaire score

  Visit M2 : two months after inclusion

Study Arms (2)

Suersen obturator then membraneous obturator

EXPERIMENTAL

Device: Suersen and membraneous obturators evaluation

Membraneous obturator then Suersen obturator

EXPERIMENTAL

Device: Suersen and membraneous obturators evaluation

Interventions

Suersen and membraneous obturators evaluation DEVICE

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.

Membraneous obturator then Suersen obturator; Suersen obturator then membraneous obturator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (1)

• 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.

  PMID: 35303932 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms; Velopharyngeal Insufficiency; Speech Disorders; Deglutition Disorders

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Pharyngeal Diseases; Stomatognathic System Abnormalities; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Elise ARRIVE, DDS

  Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 5, 2019
• Study Start: July 17, 2020
• Primary Completion: April 10, 2022
• Study Completion: July 15, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)