Page 99 - Impact of implant retained overdenture treatment and speech, oromyofunction, social participation and quality of life.

Speech, OMF and OHRQoL in OD on MDI in the maxilla
The study protocol was set up according to the principles of the Helsinki Declaration on clinical research (1975, revised in 2002). All patients received detailed oral and written information about the study protocol, treatment plan, financial costs, follow-up period, and potential risks and complications. A written consent was obtained from each patient before being enrolled in the study. The study was approved by the Ethical Committee of the Ghent University Hospital on clinical research involving human beings (EC/2014/1253) and by the Ethical Committee of the General Hospital AZ ZENO Knokke-Blankenberge. The mini dental implants (MDI) used in this study were made in one piece of a high strength pure titanium class 4 with a screw part diameter of 2.4 mm and a coronal ball attachment of 1.8 mm width (ILZ, Southern Impl. Inc, Irene, South Africa). Patients were treated under local anesthesia with free-handed flapless surgery. This means that the surgeon is piercing the mucosa and preparing the implant bed without reflecting a mucoperiosteal flap. Preoperative cone beam computed tomography (CBCT) planning and adaptation of the conventional denture in a surgical guide was performed for proper implant positioning. 5 to 6 implants were inserted with the ball head of the MDI extending 3 mm to 5 mm above the mucosa. No sutures were needed and ice packs were provided immediately after surgery. Detailed written postoperative instructions were discussed thoroughly and given to the patient. All patients were advised to abstain from denture wearing one week postoperatively until the denture was adapted for provisional loading. Additional space underneath the prosthesis was prepared to make room for the transmucosal implant ball head. The conventional prosthesis including the full palatal coverage was relined with Coesoft soft reliner gel (GC America, Chicago, Illinois, US). After 6 months the final prosthetic connection with a palatal free and reinforced horse-shoe denture was established. The prosthetic housings in the denture were imbedded by a dental lab to allow fixation of the denture with the ball attachments on the implants. Figure 2 shows the shape of the dentures in the different stages of the treatment.
Methods
The evaluation of the subjects took place in two dental clinics (University Hospital Ghent and Cosmipolis Bruges), in a testing room separated from other practices in the clinic, and adapted for phonetic evaluation. Patients were evaluated three times during their treatment (preoperatively, with provisional
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