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A New Membrane Obturator Prothesis Concept for Soft Palate Defects (VELOMEMBRANE)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mouth Neoplasms Velopharyngeal Insufficiency Speech Disorders Deglutition Disorders | Device: Suersen and membraneous obturators evaluation | Not Applicable |
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 (Clinical Trial) |
| Estimated 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 : | July 17, 2020 |
| Estimated Primary Completion Date : | April 2022 |
| Estimated Study Completion Date : | July 2022 |
| 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. |
- Voice Handicap Index (VHI) overall score [ Time Frame: 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 [ Time Frame: Visit M3 : one month after second obturator supply i.e. three months after inclusion ]Min : 0 = Non handicap to Max : 120 = voice handicap maximum
- Deglutition Handicap Index (DHI) overall score [ Time Frame: Visit M1 : one month after inclusion ]Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
- Deglutition Handicap Index (DHI) overall score [ Time Frame: Visit M2 : two months after inclusion ]Min : 0 = Non handicap to Max : 120 = deglutition handicap maximum
- Deglutition Handicap Index (DHI) overall score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Visit M3 : three months after inclusion ]Min : 0 = lower level of quality of life to Max : 100 = better level of quality of life
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Adrien NAVEAU, DDS | 05 57 62 34 34 ext +33 | adrien.naveau@chu-bordeaux.fr | |
| Contact: Olivier DELORME | 05 57 82 01 34 ext +33 | olivier.delorme@chu-bordeaux.fr |
| France | |
| CHU de Bordeaux | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Adrien NAVEAU, DDS 05 57 62 34 34 ext +33 adrien.naveau@chu-bordeaux.fr | |
| Contact: Olivier DELORME 05 57 82 01 34 ext +33 olivier.delorme@chu-bordeaux.fr | |
| Principal Investigator: Adrien NAVEAU, DDS | |
| CHU de Toulouse | Not yet recruiting |
| Toulouse, France, 31400 | |
| Contact: Florent DESTRUHAUT, DDS destruhautflorent@yahoo.fr | |
| Principal Investigator: Florent DESTRUHAUT, DDS | |
| Sub-Investigator: Caroline DE BATAILLE, DDS | |
| Study Chair: | Elise ARRIVE, DDS | Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 24, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | July 24, 2020 | ||||||||
| Actual Study Start Date ICMJE | July 17, 2020 | ||||||||
| Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A New Membrane Obturator Prothesis Concept for Soft Palate Defects | ||||||||
| Official Title ICMJE | A New Membrane Obturator Prothesis Concept for Soft Palate Defects | ||||||||
| 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. | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
14 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 2022 | ||||||||
| Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04009811 | ||||||||
| Other Study ID Numbers ICMJE | CHUBX 2018/34 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University Hospital, Bordeaux | ||||||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Bordeaux | ||||||||
| Verification Date | July 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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