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

Table 1 VELOMEMBRANE study timeline: enrollment, interventions, and assessments

		Study time
		Enrolment and allocation	Post-allocation		Close-out
Timepoints	−t₁	0	M1 30 days	M2 60 days	M3 90 days
Enrollment
Clinical examination	✓
Collection of dental arch Impressions	✓
Occlusion examinations	✓
Eligibility screening	✓
Collection of information	✓
Obtaining informed consent		✓
Allocation to groups		✓
Collection of velopharyngeal impressions		✓
Interventions
Fitting of obturator prostheses			✓	✓
Assessments
Questionnaire surveys			✓	✓	✓

ISSN: 1745-6215