Jafarpour, Dana
El-Amier, Nesma
Feine, Jocelyne
Bedos, Christophe
Abi-Nader, Samer
Esfandiari, Shahrokh
Shuster, Tibor
Zimmermann, Elizabeth
de Souza, Raphael http://orcid.org/0000-0001-8437-9991
Funding for this research was provided by:
ITI Foundation (1744-2023)
Article History
Received: 15 February 2024
Accepted: 9 April 2024
First Online: 16 April 2024
Declarations
:
: Before enrolling in this trial, all participants will be required to give informed written consent and will be made aware of their right to withdraw at any point. Only in this case will unblinding be permissible. The consent process, study documentation, and the entire trial will adhere to the guidelines outlined in the Tri-Council Policy Statement [CitationRef removed]. The McGill University REB Office approved this protocol under the reference A00-M29-23B (22–07-089). Ethical approval documents can be found in Additional file InternalRef removed. A version of this protocol has also been registered in the Clinicaltrials.gov registry under the identifier NCT03126942.Any amendments or modifications to the protocol during the trial will be formally communicated to the REB Office. If approved, these changes will be documented on Clinicaltrials.gov and disclosed to participants, allowing them time to consider continued participation.Participants will be officially enrolled in the trial only after obtaining a signed informed consent form (Additional file InternalRef removed). A researcher will explain the study’s aims and nature to each participant before they sign the consent form. It will be clarified that participation is voluntary, and participants are free to withdraw from the study at any time without providing a reason.Compensation for participants will cover the cost of transportation to data collection appointments, including the baseline assessment. Participants will receive implant overdenture treatment at no cost, along with maintenance during the follow-up period.
: Not applicable.
: The authors declare that they have no competing interests.