US 12,265,086 B2
Biomarker of gingivitis diagnosis and treatment
Dandan Chen, Bridgewater, NJ (US); Harsh Mahendra Trivedi, Hillsborough, NJ (US); James Masters, Ringoes, NJ (US); Richard P. Darveau, Camano Island, WA (US); and Jeffrey S. Mclean, Seattle, WA (US)
Assigned to Colgate-Palmolive Company, New York, NY (US)
Filed by Colgate-Palmolive Company, New York, NY (US)
Filed on Feb. 10, 2022, as Appl. No. 17/668,456.
Claims priority of provisional application 63/200,022, filed on Feb. 10, 2021.
Prior Publication US 2023/0076737 A1, Mar. 9, 2023
Int. Cl. G01N 33/68 (2006.01)
CPC G01N 33/6863 (2013.01) [G01N 2333/525 (2013.01); G01N 2333/5412 (2013.01); G01N 2333/5421 (2013.01); G01N 2333/545 (2013.01); G01N 2800/18 (2013.01)] 8 Claims
 
1. A method of identifying an individual who has been identified as having gingivitis as being a slow gingivitis responder or a high gingivitis responder and treating said individual comprising the steps of:
a) obtaining a gingivitis-derived sample of gingival crevicular fluid from the individual;
b) quantifying a cytokine consisting of IL-1β present in the gingivitis-derived sample to establish a gingivitis patient IL-1β level; and
c) comparing the gingivitis patient IL-1β level with a pre-gingivitis IL-1β level that was established by obtaining a non-gingivitis-derived sample of gingival crevicular fluid from the individual prior to the development of gingivitis and quantifying IL-1β present in the non-gingivitis-derived sample to establish a pre-gingivitis IL-1β level, wherein if the gingivitis patient IL-1β level is significantly unchanged compared to the pre-gingivitis IL-1β level, the individual is a slow gingivitis responder and if the gingivitis patient IL-1β level is significantly elevated compared to the pre-gingivitis IL-1β level, the individual is a high gingivitis responder; and/or
d) obtaining a distant healthy-derived sample of gingival crevicular fluid from the individual;
e) quantifying one or both cytokines select from the group consisting of MIF and CCL-1 present in the distant healthy-derived sample to establish a distant healthy MIF level and/or a distant healthy CCL-1 level; and
f) comparing the distant healthy MIF level and/or a distant healthy CCL-1 level with a pre-gingivitis MIF level or pre-gingivitis CCL-1 level, respectively, that was established by obtaining the non-gingivitis-derived sample of gingival crevicular fluid from the individual prior to the development of gingivitis and quantifying MIF and/or CCL-1 present in the non-gingivitis-derived sample to establish a pre-gingivitis MIF level or pre-gingivitis CCL-1 level,
wherein if the distant healthy MIF level and/or a distant healthy CCL-1 level is significantly elevated compared to the pre-gingivitis MIF level or pre-gingivitis CCL-1 level, the individual is a slow gingivitis responder and if the distant healthy MIF level and/or a distant healthy CCL-1 level is not significantly elevated compared to the pre-gingivitis MIF level or pre-gingivitis CCL-1 level, the individual is a high gingivitis responder,
the method further comprising applying to the oral cavity of the individual one or more oral care compositions comprising one or more ingredients having antimicrobial activity and free of additional ingredients that have anti-inflammatory activity if the individual is identified as a slow gingivitis responder, or applying to the oral cavity of the individual one or more oral care compositions comprising one or more ingredients having antimicrobial activity and one or more ingredients having anti-inflammatory activity if the individual is identified as a high gingivitis responder.