Here is the design of a clinical trial:

Official Title: A New Membrane Obturator Prothesis Concept for Soft Palate Defects

Included conditions:
- Mouth Neoplasms
- Velopharyngeal Insufficiency
- Speech Disorders
- Deglutition Disorders

Study Armgroups:
- {'label': 'Suersen obturator then membraneous obturator', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Suersen and membraneous obturators evaluation']}
- {'label': 'Membraneous obturator then Suersen obturator', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Suersen and membraneous obturators evaluation']}

Interventions:
- {'type': 'DEVICE', 'name': 'Suersen and membraneous obturators evaluation', 'description': 'The patient will wear one month each obturator prothesis (Suersen and membraneous obturators). The order of evaluation will be randomized in two arms.\n\nHalf 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.', 'armGroupLabels': ['Membraneous obturator then Suersen obturator', 'Suersen obturator then membraneous obturator']}

Primary Outcomes:
- {'measure': 'Voice Handicap Index (VHI) overall score', 'description': 'Min : 0 = Non handicap to Max : 120 = voice handicap maximum', 'timeFrame': 'Visit M2 : one month after first obturator supply i.e. two months after inclusion'}
- {'measure': 'Voice Handicap Index (VHI) overall score', 'description': 'Min : 0 = Non handicap to Max : 120 = voice handicap maximum', 'timeFrame': 'Visit M3 : one month after second obturator supply i.e. three months after inclusion'}

Please estimate the sample size based on the assumption: 
Power of 90%, alpha risk of 5%, no drop-out included due to the small duration of the study follow-up (3 months).
Sample size {14}
        Sample size calculation is based on the average comparison of crossover tests: the t-test for difference of means in 2 Ã 2 crossover design (N-Query software). We assume that the use of the rigid obturator will be associated with a mean VHI score of 34 and a standard deviation of 15 [14, 15]. To ensure a power of 90%, an alpha risk of 5%, and an expected difference of 15 points between the reference and new obturator, 7 patients per treatment sequence are required, thus 14 in all. No drop-out was included in the sample size calculation due to the small duration of the study follow-up (3 months).