{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,6,23]],"date-time":"2024-06-23T00:20:30Z","timestamp":1719102030385},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,6,22]],"date-time":"2024-06-22T00:00:00Z","timestamp":1719014400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,6,22]],"date-time":"2024-06-22T00:00:00Z","timestamp":1719014400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Pontis Biologics, Inc.","award":["PB2022-01","PB2022-01","PB2022-01"],"award-info":[{"award-number":["PB2022-01","PB2022-01","PB2022-01"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Oral Health"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The dissolution of dental calculus, safely and at home, is among the more challenging issues facing the over-the-counter healthcare industry. Pontis Biologics, Inc. has developed novel model of calculus development and structure and has formulated a dentifrice (Tartarase\u2122) using digestive enzymes as active ingredients that is shown to dissolve dental calculus in this Proof of Principle clinical trial.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This investigation was designed to evaluate the safety and efficacy of a novel enzyme formulation to remove existing calculus deposits in 4\u00a0weeks, measured using the Volpe-Manhold Index (V-MI) on lingual surfaces of 6 lower anterior teeth. The test formulation was compared to Crest Cavity Protection, as a control dentifrice. A total of 40 randomized test subjects began the study with 20 assigned to the control dentifrice and 20 assigned to the Tartarase groups (ten each, one brushing with Tartarase twice daily and one brushed with Tartarase and wore a dental tray filled with Tartarase for 30\u00a0min then brushed again with Tartarase, once daily).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The Crest group experienced a 12% increase in calculus, in contrast to the results of both Tartarase groups that experienced a 40% reduction in calculus in 4\u00a0weeks of unsupervised at home use of the Tartarase toothpaste formulation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This proof of principle study demonstrates that a dentifrice, formulated along the lines of the Tartarase material, is capable of combating calculus accumulation using the same oral hygiene habits that are common worldwide.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>This trial was registered retrospectively at clinicaltrials.gov and has the Unique Identification Number: NCT06139835, 14\/11\/2023.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12903-024-04498-x","type":"journal-article","created":{"date-parts":[[2024,6,22]],"date-time":"2024-06-22T09:01:55Z","timestamp":1719046915000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A proof of principle investigation of a novel enzyme formulation on dental calculus deposition: a 4-week randomized human clinical trial"],"prefix":"10.1186","volume":"24","author":[{"given":"Kimberly R.","family":"Milleman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Greg","family":"Deener","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffery L.","family":"Milleman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Mish","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reinhard","family":"Schuller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dennis","family":"Mynarcik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,6,22]]},"reference":[{"key":"4498_CR1","unstructured":"Bettcher D, Mikkelsen B, Slama S, Varenne B. 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Oral health surveillance report: trends in dental caries and sealants, tooth retention and edentulism, United States 1999\u20132004 to 2011\u20132016. 2019."},{"issue":"9","key":"4498_CR4","doi-asserted-by":"publisher","first-page":"799","DOI":"10.1111\/jcpe.12450","volume":"42","author":"L Winning","year":"2015","unstructured":"Winning L, Patterson CC, Cullen KM, Stevenson KA, Lundy FT, Kee F, Linden GJ. The association between subgingival periodontal pathogens and systemic inflammation. J Clin Periodontol. 2015;42(9):799\u2013806.","journal-title":"J Clin Periodontol"},{"issue":"Suppl 1","key":"4498_CR5","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1111\/eos.12425","volume":"126","author":"H Valen","year":"2018","unstructured":"Valen H, Scheie AA. Biofilms and their properties. 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The study was conducted in compliance with the United States Federal Regulations governing informed consent (21 CFR 50), Institutional Review Boards (21 CFR 56), clinical investigations, and applicable regulations governing sponsor and investigator conduct (21 CFR 312\/812). The process was overseen and approved by U.S Institutional Review Board, Inc., 6400 SW Court, Miami, FL 33143. The study was completed on the 6th of July, 2022.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The study subjects were informed that the information (deidentified) may be given to the FDA. It may also be given to governmental agencies in other countries. This is done so the sponsor can receive marketing approval for new products resulting from this research. The information may also be used to meet the reporting requirements of governmental agencies. The results of this research may be published in scientific journals or presented at medical meetings, but your identity will not be disclosed. The information may be reviewed by\u00a0U.S.IRB, Inc.,\u00a0a group of people who perform independent review of research as required by regulations for protecting the rights and safety of research participants. A description of this clinical trial may be available on\u00a0<u>,<\/u>\u00a0as required by U.S. Law. This web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"KRM, JLM, and RS have no competing interests. GD, BM, and DM have equity shares in Pontis Biologics, Inc. constitute as competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"720"}}