de Souza, Raphael F.
Bedos, Christophe
Esfandiari, Shahrokh
Makhoul, Nicholas M.
Dagdeviren, Didem
Abi Nader, Samer
Jabbar, Areej A.
Feine, Jocelyne S.
Funding for this research was provided by:
International Team for Implantology (1185_2016)
Article History
Received: 7 February 2018
Accepted: 19 February 2018
First Online: 23 April 2018
Ethics approval and consent to participate
: All participants will provide informed written consent prior to registration in this trial and will be informed of their right to withdraw at any time. Consent, study forms and the entire trial will follow the principles set by the Tri-Council Policy Statement [CitationRef removed]. This protocol was approved by the McGill University (A03-M07-17A) and MUHC REB (2018–3873). Additional file InternalRef removed presents ethical approval documents. A version of this protocol was registered in the ExternalRef removed registry (NCT03126942) and is available at ExternalRef removed.We will formally communicate any amendments to the protocol during the trial to the IRB. If approved, amendments will be recorded on ExternalRef removed and divulged to participants; the latter will be given time to reflect on their continued participation.Participants will be formally enrolled in the trial only after the signed informed consent form is obtained (Additional file InternalRef removed). A researcher will explain the aims and nature of the study to each participant before signing the consent form. It will be elucidated that participation is voluntary and that participant are free to withdraw from the study at any time without providing a reason. Compensation to participants will involve the cost of transportation for the data collection appointments, including the baseline assessment. Participants will receive treatment with single implant overdentures at no cost, as well as maintenance of this treatment during the follow-up period.
: Not applicable.
: The authors declare that they have no competing interests.
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