Page 74 - Impact of implant retained overdenture treatment and speech, oromyofunction, social participation and quality of life.

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Chapter 3
previous literature we expect problems pronouncing /s/, /z/, /ʃ/, /ξ/, /t/, /d/, /l/ /n/, and /r/ sounds and especially the /s/ sound is most likely to be distorted in all stages of treatment. We expect no disorders of vowels. We expect higher patients’ satisfaction with speech and overall health, and improved OHRQoL.
Materials and methods
Patient selection
The current clinical logopaedic study was part of a prospective clinical cohort study aimed at evaluating implants with different design and connection type. Patients dissatisfied with their CD in the maxilla, in terms of stability or comfort, were offered inclusion in a clinical study previously described.35 The study protocol was designed according to the principle of the Helsinki Declaration on clinical research (1975, revised in 2002). Before signing a written informed consent, every patient was informed about the study protocol, financial costs, treatment plan, follow-up period, and possible complications and risks. The study received approval from the ethical committee of the Ghent University Hospital (EC/2015/0338) on clinical research involving human beings. Subjects were included when they were at least 4 months edentulous in the maxilla, had sufficient bone volume for 4 implants of 4 mm diameter and 9-11 mm length, with absence of neurological disorders and having Dutch as their native language. In the northern part of Belgium the main language is Dutch. It is important to include people who speak the same (native) language because over languages there are other standards of speech evaluation. Subjects were excluded when they were younger than 18 years, smoking more than 10 cigarettes per day, and if general contraindications for implant placement were present like full-dose radiation in head and neck area, intravenous bisphosphonates and ongoing chemotherapy. Secondary exclusion occurred when the prosthetic space, defined as the distance between the maxillary crest and the mandible, was less than 12 mm because this space is required for the bar and prosthesis. In addition, the bone height, measured on Cone Beam CT (Planmeca, Helsinki, Finland) images, was to be sufficient. The implant-related results are not reported in the current paper.