IP Library › Granted Patent US 12,077,824
Granted Patent B2
US 12,077,824 · App. 17/471,876 · Granted Sep 3, 2024

Salivary extracellular RNA biomarkers for gingivitis

Inventors: David T. W. Wong (Beverly Hills, CA); Karolina Elzbieta Kaczor-Urbanowicz (Los Angeles, CA); Harsh Mahendra Trivedi (Hillsborough, NJ); James Masters (Ringoes, NJ)
Assignees: Colgate-Palmolive Company; The Regents of the University of California
C12Q1/6883C12Q2600/106C12Q2600/158C12Q2600/178
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Quick Facts
Patent No.
US 12,077,824
App. No.
17/471,876
Granted
Sep 3, 2024
Kind
B2
Abstract

Described herein are methods used for the detection of gingivitis and the monitoring of gingivitis in a subject.

Claims (17)

1. A method of treating gingivitis in a subject in need thereof, comprising:

a. obtaining a saliva sample of a subject;

b. detecting in the saliva sample the level of at least one biomarker selected from the group consisting of NONHSAT006501.2, NONHSAT071649, NONHSAT005224, LGALS3, AF156166, SOX4, FAM25A, AL832615, SLPI, and CRCT1;

wherein the subject is identified as being in need of treatment when the level of the at least one biomarker in the saliva sample of subject is differentially expressed when compared with the level of the biomarker in a comparator control, thereby diagnosing gingivitis in the subject;

wherein the differentially expressed level of at least one biomarker selected from the group consisting of NONHSAT071649, NONHSAT005224, AF156166, and SOX4 is increased as compared to the level of the at least one biomarker in the comparator control;

wherein the differentially expressed level of at least one biomarker selected from the group consisting of NONHSAT006501.2, LGALS3, FAM25A, and CRCT1 is decreased as compared to the level of the at least one biomarker in the comparator control; and

wherein the level of the at least one biomarker in the saliva sample is determined by measuring the level of nucleic acid of the at least one biomarker; and

c. treating the subject for gingivitis, consequent to the detection in step b;

 wherein said treating comprises one or more of dental procedures, periodontal procedures, surgical procedures, administration of pharmaceuticals, therapeutics or prophylactics; professional dental cleaning; scaling and root planning; dental restoration, use of chlorohexidine rinses; oral irrigation, interdental brushing, use of toothpastes containing Stannous, Zinc, Triclosan, and/or hydrogen peroxide; use of mouthwashes containing Triclosan, Cetylpyridinium chloride, other quaternary ammonium chlorides and/or essential oils.

2. The method of claim 1 wherein the comparator control is the level of the at least one biomarker in the saliva sample of a subject or population not having gingivitis.

3. The method of claim 1 , wherein the comparator control is at least one selected from the group consisting of a positive control, a negative control, a historical control, a historical norm, or the level of a reference molecule in the biological sample.

4. The method of claim 1 , wherein the subject is a mammal.

5. The method of claim 1 , wherein the subject has started treatment for gingivitis; further comprising the steps of:

d. detecting that the level of the at least one biomarker in the saliva sample of the subject is differentially expressed as compared to the level of the at least one biomarker in a comparator control, and

e. detecting that the subject is responsive to the treatment when the level of the at least one biomarker in the saliva sample of subject is differentially expressed when compared with the level of the biomarker in the comparator control.

6. The method of claim 5 , wherein the comparator control comprises a saliva sample of the subject obtained prior to initiation of the treatment.

7. The method of claim 5 , wherein the comparator control comprises a saliva sample of the subject obtained at an earlier time point during the treatment.

Continuity (3)
Continuation 16171418 · Oct 26, 2018
Provisional Application 62577887 · Oct 27, 2017
Related Publication 20210404005A1 · Dec 30, 2021