WO2016095606A1 - Gum condition assessment - Google Patents
Gum condition assessment Download PDFInfo
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- WO2016095606A1 WO2016095606A1 PCT/CN2015/092272 CN2015092272W WO2016095606A1 WO 2016095606 A1 WO2016095606 A1 WO 2016095606A1 CN 2015092272 W CN2015092272 W CN 2015092272W WO 2016095606 A1 WO2016095606 A1 WO 2016095606A1
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- WIPO (PCT)
- Prior art keywords
- brushing
- post
- rinse solution
- individual
- gum
- Prior art date
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Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
- G01N21/33—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0071—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by measuring fluorescence emission
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0075—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
- A61B5/0088—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for oral or dental tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14535—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring haematocrit
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/18—Dental and oral disorders
Definitions
- the invention is directed to methods of assessing a gum condition in a individual.
- gingival bleeding is a symptom of a potential gum condition. Dental professionals make this assessment when referring to bleeding that is induced by manipulating tissue with a periodontal probe at the depth of the gingival sulcus. There are many possible causes of gingival bleeding including formation and accumulation of plaque at the gum line. Some gum conditions, such as gingivitis, can be treated with proper brushing and flossing of teeth (i.e., good oral hygiene) . However, chronic gingivitis can progress to periodontitis, which is an irreversible periodontal infection characterized by alveolar bone loss, and can eventually lead to tooth loss.
- At least one report has over 70%of the Chinese population with varying degrees of gum disease. Furthermore, many individuals do not have access to dental professionals. Even with access to dental professions, there is a certain amount of subjectivity in assessing, for example, the relative status of a gum condition (e.g., mild, moderate, severe) .
- One reported approach is by counting gum bleeding sites (induced with the periodontal probe) . That is, typical measures of gum health or an improvement in a gum condition is by clinically observing a reduction in the number bleeding sites. However, the volume of bleeding is typically not taken into account. Although there may be a clinically evaluated reduction in the overall number of bleeding sites, the remaining (untreated) bleeding sites may still bleed at differing rates due to pocket depth, inflammation, and the like.
- objective measures such as quantifying blood volume, is more relevant and meaningful to the general public.
- the present invention is based, in part, on the observation that hemoglobin contained in blood can be a proxy to assess a gum condition.
- hemoglobin that is contained in gingival bleeding can be quantified (and correlated to clinical assessments of gum conditions) .
- the present invention is also based upon incorporating tooth brushing, a beneficial oral hygiene habit that can help in treating a gum condition, into the assessment method. Without wishing to be bound theory, such an approach reduces barriers for individuals to participate in the assessment, and re-enforces the need for good oral hygiene such as tooth brushing.
- the present invention incorporates a relevant oral hygiene activity into the gum condition assessment method.
- the methods herein described can also provide a means to pre-screen individuals that many need further clinical evaluation.
- the methods herein described can also provide a means to improve or assess oral care products or oral hygiene treatment regimens useful in the treatment of a gum condition.
- a first aspect of the invention provides a method of assessing a gum condition of a subject individual comprising the steps: (a) tooth brushing within an oral cavity of the subject individual; (b) post-brushing rinsing the brushed oral cavity with a post-brushing rinse solution, wherein the post-brushing rinse solution comprises a post-brushing rinse solution volume from 1 ml to 50 ml, wherein the post-brushing rinsing is for a predetermined post-brushing rinsing time from 1 second to 1 minute; (c) collecting expectorated post-brushing rinse solution from the subject individual; (d) measuring hemoglobin quantity contained in the collected post-brushing rinse solution; and (e) comparing the measured hemoglobin quantity against a known standard of gum conditions corresponding to hemoglobin quantities to assesses the gum condition of the subject individual from the compared hemoglobin quantity.
- a second aspect of the invention provides for a method of assessing a gum condition of a subject individual comprising the steps: (a) tooth brushing within an oral cavity of the subject individual; (b) post-brushing rinsing the brushed oral cavity with a post-brushing rinse solution, wherein the post-brushing rinse solution comprises a post-brushing rinse solution volume from 1 ml to 50 ml, wherein the post-brushing rinsing is for a predetermined post-brushing rinsing time from 1 second to 1 minute; (c) collecting expectorated post-brushing rinse solution from the subject individual; and (d) visually comparing the collected post-brushing rinse solution against a known standard of gum conditions corresponding to hemoglobin quantities to assess the gum condition of the subject individual.
- a third aspect of the invention provides for a method of assessing effectiveness of a product or regimen in the treatment of a gum condition comprising the steps:
- post-brushing rinsing the brushed oral cavity with a first post-brushing rinse solution
- the post-brushing rinse solution comprises a post-brushing rinse solution volume from 1 ml to 50 ml, wherein the post-brushing rinsing is for a predetermined post-brushing rinsing time, wherein the predetermined post-brushing rinsing time is from 1 second to 1 minute;
- a fourth aspect of the invention provides for a computer-aided system of assessing a gum condition of a subject individual comprising: (a) a sampling section for sampling expectorated post-brushing rinsing solution of the subject individual; (b) a measuring section in communication with the sampling section, wherein the measuring section is configured to measure hemoglobin quantity contained in the expectorated post-brushing rinsing solution; and (c) a computing section in communication with the measuring section, wherein the computing section is configured for receiving and statistically analyzing the measured hemoglobin to the gum condition.
- An optional, but preferred, initial step is to provide instructions to the individual regarding the methods described herein. Instructions may be provided by a live demonstration, pre-recorded video, literature (e.g., text and pictures) , web-based, or combination thereof. Preferably the instructions comprise a video since users typically find it easier to model viewed behavior as compared to reading about it. A pre-recorded video is more cost effective than a live demonstration by an instructor. Specific mention is made to instructing the individual about brushing; preferably having the individual tooth brushing their own oral cavity. Alternatively, a trained tester brushes the individual’s oral cavity. Other oral hygiene products and regimens may be optionally included. The instructions may also provide the added benefit of teaching or reinforcing proper tooth brushing techniques (or other oral hygiene habits) .
- An optional, but preferred step after optionally providing instructions to the individual is pre-rinsing the oral cavity of the individual, before the brushing step (described below) , with a pre-rinse solution.
- the pre-rinse solution comprises a predetermined pre-rinse volume, more preferably the predetermined pre-rinse volume is from 1 ml to 5 ml, yet more preferably from 1 ml to 2.5 ml.
- having less than 1 ml will leave the oral cavity too dry, even perhaps irritating the mouth.
- volumes greater than about 2.5 ml may lead to undesirably variability in testing.
- Another advantage of the pre-rinsing step is to potentially remove contaminants from the oral cavity that could negatively impact results.
- the pre-rinsing step is for a predetermined pre-rinsing time, more preferably the predetermined pre-rinsing time is from 1 second to 1 minute, yet more preferably from 2 seconds to 10 seconds.
- the pre-rinse solution comprises from 90%to 100%, more preferably from 95%to 100%, yet more preferably 98%to 100%water by weight of the pre-rinse solution.
- the pre-rinse solution may comprise minor ingredients such as salt (to provide an isotonic saline solution) or contain antibacterial agents and the like.
- the pre-rinse solution is simply water. Indeed simply using water is cost effective.
- An optional, but preferred step after optionally pre-rinsing the oral cavity of the individual, but before the brushing step comprises the step of immersing a brush in a brush immersing solution.
- the immersing solution comprises from 90%to 100%, more preferably from 95%to 100%, yet more preferably 98%to 100%water by weight of the immersing solution.
- the brush immersing solution may comprise minor ingredients such as salt (to provide an isotonic saline solution) or contain antibacterial agents and the like. More preferably the immersing solution is simply water. Indeed simply using water is cost effective.
- the step of immersing the brush is for a predetermined immersing time, preferably the predetermined immersing time is from 0.1 second to 5 seconds, more preferably from 0.5 seconds to 2 seconds, alternatively about 1 second.
- a step in the present invention is tooth brushing within an oral cavity of the individual.
- the individual may conduct the tooth brushing or a trained tester may conduct the tooth brushing to the individual.
- the tooth brushing further comprises tooth brushing for a predetermined brushing time.
- the predetermined brushing time is from 30 seconds to 5 minutes, more preferably from 1 minute to 3 minutes, alternatively for about 2 minutes.
- the tooth brushing may by way of a manual toothbrush or an automated toothbrush (e.g., an electric toothbrush, gum brush (e.g., Gum Health TM ) ) .
- an automated toothbrush e.g., an electric toothbrush, gum brush (e.g., Gum Health TM )
- the term “tooth brushing” should be construed broadly to include those brushes designed to brush gums.
- the portion of the oral cavity that is brushed may include a tooth or gum, or combination thereof. In one non-limiting example, the interface between the tooth and gum is brushed.
- a step in the present invention is post-brushing rinsing the oral cavity with a post-brushing rinse solution. Best results are typically obtained when the post-brushing rinsing step is conducted immediately after the aforementioned tooth brushing step.
- the post-brushing rinse solution comprises a predetermined post-brushing rinse solution volume.
- the predetermined post-brushing rinse solution volume is from 1 ml to 50 ml, more preferably from 5 ml to 40 ml, yet more preferably from 5 ml to 15 ml, alternatively about 10 ml.
- the volume is less than 5 ml, it may lead to undesirably variability in testing. However, volumes greater than 50 ml may provide for a hemoglobin concentration that is too low to be accurately detected by some methods (e.g., Ultra Violet–Visible Light Analysis described in further detail below) . More than one post-brushing rinse can be employed.
- the post-brushing rinsing step is for a predetermined post-brushing rinsing time. More preferably the predetermined post-brushing rinsing time is from 1 second to 1 minute, yet more preferably from 5 seconds to 15 seconds, alternatively about 10 seconds.
- the post-brushing rinse solution comprises from 90%to 100%, more preferably from 95%to 100%, yet more preferably 98%to 100%water by weight of the pre-rinse solution.
- the post-brushing rinse solution may comprise minor ingredients such as salt (to provide an isotonic saline solution) or contain antibacterial agents and the like.
- the post-brushing rinse solution is simply water. Indeed simply using water is cost effective.
- step of collecting the saliva sample from the brushed oral cavity of the individual comprising collecting the post-brushing rinse solution.
- a step in the present invention is collecting expectorated post-brushing rinse solution from the individual. This can be way of a cup, test tube, vial, or the like.
- centrifuging the collected saliva sample before measuring hemoglobin quantity is centrifuging the collected saliva sample before measuring hemoglobin quantity (described below) .
- the centrifuging step is for a predetermined centrifuging time, more preferably the predetermined centrifuging time is from 1 minute to 20 minutes, yet more preferably from 5 minutes to 15 minutes.
- the centrifuging step is spun at a speed as to reach at centrifugal force greater than 30 gravitational force (g-force) , preferably the centrifugal force is between 30 g-force to 25,000 g-force, preferably from 8,000 g-force to 12,000 g-force, alternatively about 10,733 g-force.
- centrifuging the collected saliva sample removes solids or other ingredients that may interfere with measuring hemoglobin quantity.
- a step in present invention is measuring hemoglobin quantity contained in the collected post-brushing rinse solution (or centrifuged post-brushing rinse solution) .
- Any known method of measuring hemoglobin quantity may be used including, but not limited to, colormetric, spectrophotometric, chemical indicator, ELISA, colloidal gold techniques, and other immunological techniques, and the like.
- UVVLA Ultra Violet–Visible Light Analysis
- a step in present invention is comparing the measured hemoglobin quantity against a known standard of gum conditions corresponding to hemoglobin quantities.
- a known standard of gum conditions corresponding to hemoglobin quantities are commercially available.
- the known standard will depend upon the hemoglobin quantity measuring test employed.
- a step in the present invention is visually comparing the collected post-brushing rinse solution against a known standard of gum conditions corresponding to hemoglobin quantities.
- the collected post-brushing rinse solution may simple be visually compared, i.e., with an unaided eye, to physical standards, pictures, photo, video or the like.
- An optional, but preferred step in the methods of the present invention is communicating the assessed gum health.
- This tool much like the initial optional instructions, can be provided with a live consultation, pre-recorded video, literature (e.g., text and pictures) , web-based, or combinations thereof.
- the communication is preferably tailored to the specific gum health status assessed, most even more preferably contain information what can and should be done by the individual to remedy the individual’s gum condition if an undesirable gum condition is assessed. Obtaining and sselling an endorsement or certification from a well recognized and respected industry group may also be helpful in adoption of the methods described herein.
- Another aspect of the invention provides for a method of assessing effectiveness of a product or regimen in the treatment of a gum condition of an individual.
- the method comprising the steps: firstly assessing an individual’s first gum condition comprising the sub-steps: (i) tooth brushing within an oral cavity of the individual; (ii) post-brushing rinsing the brushed oral cavity with a first post-brushing rinse solution for a predetermined post-brushing rinsing time, wherein the predetermined post-brushing rinsing time is from 1 second to 1 minute; (iii) collecting expectorated first post-brushing rinse solution from the individual; (iv) measuring hemoglobin quantity contained in the first post-brushing rinse solution; and (v) comparing the first measured hemoglobin quantity against a known standard of gum conditions corresponding to hemoglobin quantities to assesses the first gum condition of the individual.
- a second step is subjecting the individual to the product or regimen.
- the product or regimen may comprise a toothbrush, toothpaste, mouth rinse, floss, teeth whitening strips, or combinations thereof. Indeed new ingredients or products may be designed or tested.
- a third step is assessing the individual’s second gum condition (after the individual is subjected to the product or regimen) comprising the sub-steps: (i) tooth brushing within the oral cavity of the individual; (ii) post-brushing rinsing the brushed oral cavity with a second post-brushing rinse solution for the predetermined post-brushing rinsing time; (iii) collecting expectorated second post-brushing rinse solution from the individual; (iv) measuring hemoglobin quantity contained in the second post-brushing rinse solution; and (v) comparing the second measured hemoglobin quantity against the known standard of gum conditions corresponding to hemoglobin quantities to assess the second gum condition of the individual.
- a fourth step is comparing the first gum condition assessment to the second gum condition assessment to assess the effectiveness of the product or regimen in the treatment of the gum condition in the individual.
- Preferred aspects of the methods include those as previously described for the earlier aspects of the invention (that are not repeated here for the sake of brevity) .
- Another aspect of the invention provides for a computer-aided system of assessing a gum condition of a subject individual comprising: (a) a sampling section for sampling expectorated post-brushing rinsing solution of the subject individual; (b) a measuring section in communication with the sampling section, wherein the measuring section is configured to measure hemoglobin quantity contained in the expectorated post-brushing rinsing solution; (c) a computing section in communication with the measuring section, wherein the computing section is configured for receiving and statistically analyzing the measured hemoglobin to a gum condition.
- the computing section comprises: (i) an input module in communication with the measuring section, wherein the input module is for inputting input data, wherein the input data comprises demographic information of the subject individual or medical information of the subject individual; and (ii) a data processing module in communication with the input module, wherein the data processing module is configured for statistically analyzing the input data to correlate with a statistical significance to the gum condition.
- the step of measuring hemoglobin quantity contained in the saliva sample is Ultra Violet–Visible Light Analysis ( “UVVLA” ) as described earlier.
- UVVLA Ultra Violet–Visible Light Analysis
- the study is a two-leg, 3 days clinical study. Around 40 qualified subjects meeting all the study entrance criteria are enrolled into the study. Gingivitis is measured by hemoglobin sampled at baseline and at day 3.
- Baseline Visit At the first day, subjects are asked to read and sign an informed consent and receive a signed copy for their records. Personal medical history information is obtained and reviewed and retained as site source documentation. Demographic information and inclusion criteria are obtained and documented on the appropriate case report form (CRF) . Then subjects receive power brush sampling for gingival hemoglobin. Then all the subjects are given one tube of Regular Caries Protection toothpaste (Lot #40671864AA) and one MeiLiLiangJie toothbrush (Lot #OM003) .
- UVVLA Ultra Violet–Visible Light Analysis
- Subjects reporting for their visit refrain from: performing any oral hygiene prior to their appointment; and consuming anything by mouth (except a small amount of water) at least 4 hours prior to their next visit.
- Subjects agree to receive dental prophylaxis required by study.
- Subjects self-report if there is visible bleeding when brushing in past 2 weeks. No periodontal disease and other oral diseases except tartar.
- Subjects are excluded from study participation where there is evidence of any one the following: (i) periodontal disease beyond gingivitis (as noted above in inclusion criteria) ; (ii) teeth that are carious, fully-crowned, extensively restored and have heavy dental calculus; (iii) teeth with unresolved carious lesions; (iv) any condition which requires antibiotic premedication for the administration of a dental prophylaxis; (v) self-reported pregnancy or intent to become pregnant during the course of the study and nursing females; (vi) atypical discoloration or pigmentation in the gingival tissue; (vii) fixed facial orthodontic appliances; (viii) use of antibiotics any time during the study; (ix) any diseases or conditions that could be expected to interfere with the subject safely completing the study; and (x) inability to undergo imaging or other study procedures.
- Subjects may be excluded from the study or the analysis due to any one of the following: (i) use of antibiotics any time during the study; (ii) pregnancy or development an intercurrent medical condition which puts the subject at increased risk or invalidates the results of the study; (iii) use of any oral care products other than assigned study products; (iv) subject reporting for their visit having performed any oral hygiene prior to their appointment; (v) subjects reporting for their visit having consumed anything by mouth (except a small amount of water) at least 4 hours prior to their next visit; and (vi) UVVLA score >0.2.
- subjects are randomized to two methods according to their visit order.
- subjects are stratified based on the power brush UVVLA scores, age, gender, and smoking status within each cohort.
- Subjects are randomly assigned to two cohorts (Prophylaxis/Non-prophylaxis) . Subjects who reside in the same household are assigned to the same group.
- RGB Digital Imaging for sample picture taking This system consists of a S2 Pro CCD high resolution digital camera manufactured by Fuji or a similar camera. It is equipped with a Nikon Micro Nikkor lens with a linear polarizer to permit cross-polarized light or similar optical system. Dedo lights, mounted to an imaging rig, provides lighting.
- the system Prior to daily use, the system is calibrated to assure proper operation. Additionally, a color standard is centered and imaged every hour, and then is removed prior to imaging samples. For each examination period, the room is dark. The sample tube is placed on the chin rest, and a white balance is placed behind the sample tube. Operator follows standard capture image process and capture sample imaging.
- Gingival hemoglobin method sampling procedure sampling and storage Sampling method “1” by manual brush brushing and sample method “2” by Power brush brushing, both follow the same procedure listed as follows: (1) Watch the video of brush instruction; (2) Take an empty tube; (3) Take 2ml water to rinse the whole mouth for 5 seconds; (4) Open the toothbrush from its packaging and put the whole brush head into 30ml water for 1 second; (5) Brush whole teeth thoroughly for 2 minutes by oneself, expectorate in the tube; (6) After brushing, immediately rinse with 10ml water for 10 seconds, expectorate in the tube; (7) Label the sample; (8) Centrifuge the sample at 10, 733 g-force for 10 minutes; (9) Take 1ml into a 2ml tube, for UVVLA and sample picture taking immediately.
- UVLA Ultraviolet–visible spectroscopy method
- sample size is based on logistical considerations and not power implications. Approximate 40 qualified subjects are enrolled into the study.
- the mean score for the Prophy group is equal to the mean score of the Non-prophy group.
- the mean score for the Prophy group is not equal to the mean score of the Non-prophy group.
- the minimum detection level for UVVLA is 20. If the score is less than 20, the level is changed to 10 as a final score. Log 10 transformations are applied to UVVLA variables to better meet the normal distribution hypothesis. The change from baseline is investigated using paired t-tests. Analysis of covariance is used to compare groups (Prophy/Non-prophy) with the efficacy variable of UVVLA. A separate statistical model is used to test group difference at each visit. The baseline value of UVVLA endpoint is used as a covariate in each model. Statistical comparisons are two-sided with a 0.05 significance level.
- Study Population Referring to Table 1 below, the study population consists of forty-two (42) subjects enrolled at the first visit and forty-two (42) subjects completing the study. Subjects’ age ranged from 20 to 53 years with a mean of 33.74 and standard deviation of 7.75 years. Thirty-five (83%) of the subjects are female.
- Non-Prophy group and Prophy group starts from a Mean (SD) value of 1.93 (0.56) and 2.05 (0.49) , respectively.
- the Mean (SD) value is 1.80 (0.57) and 1.61 (0.51) , respectively.
- Non-Prophy group and Prophy group starts from a Mean (SD) value of 2.29 (0.50) and 2.31 (0.37) , respectively.
- the Mean (SD) value is 2.07 (0.55) and 1.78 (0.51) , respectively.
- the variable of deeper color is analyzed.
- the range of the score comparing pre and post treatment images is -4 to 4.
- the Prophy group treatment is dental prophylaxis; and the Non-Prophy group treatment, is the normal oral hygiene habit group.
- the average score of all graders are calculated for each set of images (pre &post images) .
- a simple t-test method is applied to test the score to assess if there is a significant change after treatment.
- Treatment is considered statistically significantly better after applying treatment if the p-value is less than or equal to 0.05 (2-sided) and the average is negative.
- a lower score means less redness after day 3.
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Abstract
Description
Claims (15)
- A method of assessing a gum condition of a subject individual comprising the steps:(a) tooth brushing within an oral cavity of the subject individual;(b) post-brushing rinsing the brushed oral cavity with a post-brushing rinse solution comprising a post-brushing rinse solution volume from 1 ml to 50 ml, for a predetermined post-brushing rinsing time, wherein the predetermined post-brushing rinsing time is from 1 second to 1 minute;(c) collecting expectorated post-brushing rinse solution from the subject individual;(d) measuring hemoglobin quantity contained in the collected post-brushing rinse solution; and(e) comparing the measured hemoglobin quantity against a known standard of gum conditions corresponding to hemoglobin quantities to assesses the gum condition of the subject individual from the compared hemoglobin quantity.
- A method of assessing a gum condition of a subject individual comprising the steps:(a) tooth brushing within an oral cavity of the subject individual;(b) post-brushing rinsing the brushed oral cavity with a post-brushing rinse solution comprising a post-brushing rinse solution volume from 1 ml to 50 ml, for a predetermined post-brushing rinsing time, wherein the predetermined post-brushing rinsing time is from 1 second to 1 minute;(c) collecting expectorated post-brushing rinse solution from the subject individual; and(d) visually comparing the collected post-brushing rinse solution against a known standard of gum conditions corresponding to hemoglobin quantities to assess the gum condition of the subject individual.
- The method of any one the preceding claims, wherein the predetermined post-brushing rinsing time is from 5 seconds to 15 seconds.
- The method of any one of the preceding claims, wherein the tooth brushing further comprising:tooth brushing for a predetermined brushing time, wherein the predetermined brushing time is from 30 seconds to 5 minutes, preferably from 1 minute to 3 minutes; andwherein the oral cavity comprises a tooth, a gum, or combinations thereof.
- The method of any one of the preceding claims, further comprising a step of pre-rinsing the oral cavity, before the brushing step, with a pre-rinse solution, wherein the pre-rinsing step is for a predetermined pre-rinsing time, wherein the predetermined pre-rinsing time is from 1 second to 1 minute, preferably from 2 seconds to 10 seconds.
- The method of claim 5, wherein the print-rinse solution having a pre-rinse volume from 1 ml to 5 ml.
- The method of any one of the preceding claims, wherein the post-brushing rinse solution and the pre-rinse solution are water.
- The method of any one of the preceding claims, further comprising the step of immersing a toothbrush in a brush immersing solution before the brushing step; and wherein the step of immersing the brush is for a predetermined immersing time, wherein the predetermined immersing time is from 0.1 second to 5 seconds, preferably from 0.5 seconds to 2 seconds.
- The method of any one the preceding claims, further comprising the step of centrifuging the collected expectorated post-brushing rinse solution.
- The method of claim 9, wherein the centrifuging step is for a predetermined centrifuging time, wherein the predetermined centrifuging time is from 1 minute to 20 minutes, preferably from 5 minutes to 15 minutes; and wherein the centrifuging step is conducted at a centrifugal force greater than 30 gravitational-force, preferably the centrifugal force is between 30 gravitational-force to 25,000 gravitational-force.
- The method of any one of claims 1, or 3-10, wherein the step of measuring hemoglobin quantity contained in the collected expectorated post-brushing rinse solution is by Ultra Violet –Visible Light Analysis ( “UVVLA” ) .
- A method of assessing effectiveness of a product or regimen in the treatment of a gum condition comprising the steps:(a) assessing an individual’s first gum condition comprising the steps:(i) tooth brushing within an oral cavity of the individual;(ii) post-brushing rinsing the brushed oral cavity with a first post-brushing rinse solution comprising a post-brushing rinse solution volume from 1 ml to 50 ml, for a predetermined post-brushing rinsing time from 1 second to 1 minute;(iii) collecting expectorated first post-brushing rinse solution from the individual;(iv) measuring hemoglobin quantity contained in the first post-brushing rinse solution;(v) comparing the first measured hemoglobin quantity against a known standard of gum conditions corresponding to hemoglobin quantities to assesses the first gum condition of the individual;(b) subjecting the individual to the product or regimen;(c) assessing the individual’s second gum condition comprising the steps:(i) tooth brushing within the oral cavity of the individual;(ii) post-brushing rinsing the brushed oral cavity with a second post-brushing rinse solution with the post-brushing rinse solution volume and for the predetermined post-brushing rinsing time;(iii) collecting expectorated second post-brushing rinse solution from the individual;(iv) measuring hemoglobin quantity contained in the second post-brushing rinse solution;(v) comparing the second measured hemoglobin quantity against the known standard of gum conditions corresponding to hemoglobin quantities to assess the second gum condition of the individual; and(d) comparing the first gum condition assessment to the second gum condition assessment to assess the effectiveness of the product or regimen in the treatment of the gum condition in the individual.
- A computer-aided system of assessing a gum condition of a subject individual comprising:(a) a sampling section for sampling expectorated post-brushing rinsing solution of the subject individual;(b) a measuring section in communication with the sampling section, wherein the measuring section is configured to measure hemoglobin quantity contained in the expectorated post-brushing rinsing solution; and(c) a computing section in communication with the measuring section, wherein the computing section is configured for receiving and statistically analyzing the measured hemoglobin to the gum condition.
- The computer-aided system according to claim 13, wherein the computing section comprises:(i) an input module in communication with the measuring section, wherein the input module is for inputting input data, wherein the input data comprises demographic information of the subject individual or medical information of the subject individual; and(ii) a data processing module in communication with the input module, wherein the data processing module is configured for statistically analyzing the input data to correlate with a statistical significance to the gum condition.
- The computer-aided system according to either claim 13 or 14, wherein the step of measuring hemoglobin quantity contained in the saliva sample is Ultra Violet –Visible Light Analysis ( “UVVLA” ) conducted between 340 nm to 440 nm.
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
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MX2017008202A MX2017008202A (en) | 2014-12-19 | 2015-10-20 | Gum condition assessment. |
CA2968718A CA2968718A1 (en) | 2014-12-19 | 2015-10-20 | Gum condition assessment |
CN201580068261.XA CN107530153A (en) | 2014-12-19 | 2015-10-20 | gum condition evaluation |
BR112017011455A BR112017011455A2 (en) | 2014-12-19 | 2015-10-20 | evaluation of gum disease |
EP15869117.0A EP3232985A1 (en) | 2014-12-19 | 2015-10-20 | Gum condition assessment |
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CNPCT/CN2014/094346 | 2014-12-19 | ||
PCT/CN2014/094346 WO2016095202A1 (en) | 2014-12-19 | 2014-12-19 | Gum condition assessment |
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WO2016095606A1 true WO2016095606A1 (en) | 2016-06-23 |
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PCT/CN2014/094346 WO2016095202A1 (en) | 2014-12-19 | 2014-12-19 | Gum condition assessment |
PCT/CN2015/092272 WO2016095606A1 (en) | 2014-12-19 | 2015-10-20 | Gum condition assessment |
Family Applications Before (1)
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PCT/CN2014/094346 WO2016095202A1 (en) | 2014-12-19 | 2014-12-19 | Gum condition assessment |
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EP (1) | EP3232985A1 (en) |
CN (1) | CN107530153A (en) |
BR (1) | BR112017011455A2 (en) |
CA (1) | CA2968718A1 (en) |
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EP3865048A1 (en) * | 2020-02-14 | 2021-08-18 | Koninklijke Philips N.V. | Providing an indication of a person's gum health |
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JP2002181815A (en) * | 2000-12-13 | 2002-06-26 | Godo Shusei Co Ltd | Immunoassay for saliva constituent |
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CN101501479A (en) * | 2006-08-17 | 2009-08-05 | 宝洁公司 | Salivary analysis |
EP2631648A2 (en) * | 2009-04-24 | 2013-08-28 | Kao Corporation | Therapeutic target for periodontal disease. |
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-
2014
- 2014-12-19 WO PCT/CN2014/094346 patent/WO2016095202A1/en active Application Filing
-
2015
- 2015-10-20 CN CN201580068261.XA patent/CN107530153A/en active Pending
- 2015-10-20 CA CA2968718A patent/CA2968718A1/en not_active Abandoned
- 2015-10-20 WO PCT/CN2015/092272 patent/WO2016095606A1/en active Application Filing
- 2015-10-20 MX MX2017008202A patent/MX2017008202A/en unknown
- 2015-10-20 BR BR112017011455A patent/BR112017011455A2/en not_active Application Discontinuation
- 2015-10-20 EP EP15869117.0A patent/EP3232985A1/en not_active Withdrawn
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JP2002181815A (en) * | 2000-12-13 | 2002-06-26 | Godo Shusei Co Ltd | Immunoassay for saliva constituent |
JP2004329141A (en) * | 2003-05-09 | 2004-11-25 | Bml Inc | Method for detecting periodontal disease |
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EP2631648A2 (en) * | 2009-04-24 | 2013-08-28 | Kao Corporation | Therapeutic target for periodontal disease. |
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CN107530153A (en) | 2018-01-02 |
CA2968718A1 (en) | 2016-06-23 |
EP3232985A1 (en) | 2017-10-25 |
BR112017011455A2 (en) | 2018-04-03 |
MX2017008202A (en) | 2017-09-13 |
WO2016095202A1 (en) | 2016-06-23 |
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