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Computer-assisted technologies enhance oral healthcare access by the elderly. Despite promising in vitro reports on digital denture materials, evidence from randomized clinical trials (RCTs) is lacking to verify their performance. This cross-over RCT will investigate whether 3D-printed implant-retained mandibular overdentures (IMO) are more satisfactory for edentulous seniors than those made through traditional methods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/design<\/jats:title>\n                    <jats:p>We will recruit 26 completely edentulous participants (any sex\/gender) based on the following eligibility criteria: age\u2009\u2265\u200960\u00a0years, no tooth extraction in the past 12\u00a0months, two implants in the lower jaw, and need for new dentures in both jaws. Each participant will receive two denture pairs, either manufactured by 3D printing or traditionally, to be worn in a random order. A timeline of 3\u00a0months with each denture pair will be considered for outcome assessment (total: 6\u00a0months). Patient satisfaction with dentures will be measured by the McGill Denture Satisfaction Questionnaire. We will evaluate other patient-reported outcomes (including oral health-related quality of life) as well as clinician-assessed quality and cost. At the end of the trial, participants will choose which denture pair they wish to keep and interviewed about their experiences with the 3D-printed IMO. The quantitative and qualitative data will be incorporated through an explanatory mixed-methods strategy. A final quantitative assessment will happen after 12\u00a0months with the preferred IMO to assess the long-term performance and maintenance needs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This mixed-methods RCT will explore patient experiences with 3D-printed IMOs, aiming to assess the potential for altering clinical practice and dental public health policies. Our results will inform policies by showing whether 3D printing offers comparable outcomes at lower costs, facilitating greater access to oral care for the elderly.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov, NCT06155630, Registered on 04 December 2023.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT06155630\">https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT06155630<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-024-08097-7","type":"journal-article","created":{"date-parts":[[2024,4,16]],"date-time":"2024-04-16T11:19:33Z","timestamp":1713266373000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT"],"prefix":"10.1186","volume":"25","author":[{"given":"Dana","family":"Jafarpour","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nesma","family":"El-Amier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jocelyne","family":"Feine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christophe","family":"Bedos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samer","family":"Abi-Nader","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shahrokh","family":"Esfandiari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tibor","family":"Shuster","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Zimmermann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8437-9991","authenticated-orcid":false,"given":"Raphael","family":"de Souza","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,4,16]]},"reference":[{"key":"8097_CR1","doi-asserted-by":"publisher","first-page":"1239","DOI":"10.1590\/1413-81232015214.13672015","volume":"21","author":"M Cardoso","year":"2016","unstructured":"Cardoso M, Balducci I, Telles DDM, Louren\u00e7o EJV, Nogueira J\u00fanior L. 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Tri-council policy statement: ethical conduct for research involving humans 2014."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08097-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08097-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08097-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,16]],"date-time":"2024-04-16T11:20:39Z","timestamp":1713266439000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-08097-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,16]]},"references-count":74,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8097"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08097-7","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-3873159\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,16]]},"assertion":[{"value":"15 February 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 April 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 April 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"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 [\n                      \n                      ]. The McGill University REB Office approved this protocol under the reference A00-M29-23B (22\u201307-089). Ethical approval documents can be found in Additional file\n                      \n                      . 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\n                      \n                      ). A researcher will explain the study\u2019s 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.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"267"}}