58 Chapter 4 oral and written information about the trial. Signed informed consent was obtained from each participant. This 1-year trial was independently reviewed and approved by the Medical Ethical Committee of the UMCG (METc 2017/551ABR NL63532.042.17) and the study was registered in the Dutch Trial Register (NTR6742/NL6561, available at https://trialsearch.who.int/Trial2.aspx- ?TrialID=NTR6742). This study was conducted in accordance with the 2013 revised requirements of the Helsinki Declaration of 1975 and the CONSORT Guidelines. Each participant was randomly assigned to be treated with an overdenture supported by either two (experimental group) or four (control group) implants via sealed envelope randomisation. Figure 4.1 | Consort 2010 Flow Diagram. Surgical procedure The surgical procedures for all the participants were planned with a computer 3D virtual surgical planning software (Proplan CMF software; Materialise, Leuven, Belgium) to ensure optimised
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