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WO1998022025A1 - Procede d'utilisation pour determiner le risque de caries et dispositif de test particulierement adapte a cet effet - Google Patents

Procede d'utilisation pour determiner le risque de caries et dispositif de test particulierement adapte a cet effet Download PDF

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Publication number
WO1998022025A1
WO1998022025A1 PCT/EP1997/006214 EP9706214W WO9822025A1 WO 1998022025 A1 WO1998022025 A1 WO 1998022025A1 EP 9706214 W EP9706214 W EP 9706214W WO 9822025 A1 WO9822025 A1 WO 9822025A1
Authority
WO
WIPO (PCT)
Prior art keywords
absorbent material
test device
container
saliva
mass
Prior art date
Application number
PCT/EP1997/006214
Other languages
German (de)
English (en)
Inventor
Claus-Jürgen MÖLL
Theodor Paessens
Original Assignee
M & M Dental-Medizin Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by M & M Dental-Medizin Gmbh filed Critical M & M Dental-Medizin Gmbh
Priority to EP97951153A priority Critical patent/EP0952787A1/fr
Priority to AU54801/98A priority patent/AU5480198A/en
Publication of WO1998022025A1 publication Critical patent/WO1998022025A1/fr

Links

Classifications

    • 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
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/528—Atypical element structures, e.g. gloves, rods, tampons, toilet paper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B2010/0003—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements including means for analysis by an unskilled person

Definitions

  • the invention relates to the use of an absorbent material and a transport medium for determining the risk of caries in a subject.
  • the method is particularly applicable to humans, but use in animals is also possible.
  • WO 96/18902 AI describes a possibility for the layperson to obtain information about his personal caries risk in a simple, fast, convenient and inexpensive manner.
  • the subject inserts a carrier with an absorbent material into his mouth.
  • the absorbent material which consists in particular of dry medical cotton wool, is coated with a coating that stimulates the metabolism of the microorganisms in the oral cavity. As a result, the pH drops. After the coating has dissolved, the saliva or at least part of the saliva is absorbed by the absorbent material.
  • the subject briefly rolls the damp absorbent material back and forth on a test strip until the strip changes color.
  • the pH value and thus the risk of caries which is particularly high at a low pH value, can be read by comparing the discoloration with a color scale arranged next to the test strip.
  • the known method allows a general statement about the risk of caries, but an indication of the type and number of microorganisms in the oral cavity and thus the specific causes of the risk of caries would be desirable. worth it because the individual types of microorganisms have a different function in the development of caries.
  • bacteriological examinations should be carried out in special laboratories.
  • the quality of the bacteriological tests is decisively influenced by the quality of the material that is made available to the laboratory for the test.
  • the transport of the test material in particular has proven to be a significant weak point.
  • the pathogens must therefore be protected against drying out and oxidation damage using a suitable transport medium. Drying out is usually achieved by embedding in a suitable semi-solid agar medium and oxidation damage by means of a protective gas containing nitrogen or carbon dioxide, so that the pathogens at
  • Saliva tests and tools for removing saliva for analysis purposes have long been known. Such a method is described for example in DE 36 32 303 AI.
  • a method is described for example in DE 36 32 303 AI.
  • Here is an elastic, absorbent, inert body chewed by the test subject and then placed in a centrifuge tube provided with a perforated bottom.
  • the method is only carried out in dental practice. It must be ensured that, apart from the microorganisms of the oral cavity, no other germs get on the elastic body.
  • EP 0 418 739 AI describes a device for removing saliva from the oral cavity.
  • the device consists of an absorbent material, a pad, which is clamped in a groove in a plastic stick. To remove the saliva, take the stick and insert the pad attached to it into the oral cavity. After the pad has absorbed a sufficient amount of saliva, it can be stored in a container until the test is carried out.
  • the container consists of a centrifuge tube into which an inner tube is inserted.
  • an additional aid is required, which consists of a plate with an opening for the plastic stick.
  • a saliva sample taken during a dental examination has two major disadvantages.
  • the relatively large saliva production over the course of a day which is around 20 ml per hour, leads to a relatively low concentration of the microorganisms in the oral cavity compared to the night's sleep during the 7th due to the antibacterial activity of the saliva and the relatively high amount of saliva Hours a total of only 20 ml of saliva can be produced.
  • the growth rate for plaque is reduced at night, it can be concluded from this information that the destructive effects of cariogenic microorganisms are particularly pronounced during sleep and that their concentration in the oral cavity is highest immediately after sleep.
  • the known methods either require the assistance of a medical specialist, since the one method is too cumbersome and complicated for a layperson and is therefore only suitable for analyzing saliva extracted in medical practice. As has already been stated, however, a precise analysis of the saliva taken immediately after the subject's night's sleep is particularly desirable.
  • the other known methods only show the application of certain microorganisms or their metabolic products, but do not provide any information about the number of different microorganisms.
  • test methods and test devices for saliva are known from WO 92/16842 AI and WO 95/02822 AI.
  • the saliva is not removed immediately after the subject's night's sleep, and the test facilities have no transport medium to store the saliva for a long time until it is analyzed.
  • test device known from WO 95/27205 AI has a test stick with a predetermined breaking point so that the handle part can be removed after the saliva has been removed.
  • the invention is therefore based on the object of developing a simple and inexpensive possibility for determining the risk of dental caries and its causes in a considerably more precise manner.
  • a sterile absorbent material with a fixed, predetermined absorption capacity and a sterile transport medium for determining the risk of caries in a test subject, with a) the subject immediately after the night's sleep with the absorbent material over the surface strokes his oral cavity, especially over the palate, cheek pockets and tooth surfaces, b) the absorbent material is added to the transport medium, and c) the type and / or number of the microorganisms located on / in the absorbent material is determined and the caries risk is determined with the aid of the results obtained.
  • the test person can hand over the transport medium with the absorbent material used to his dentist, who either analyzes the sample himself or forwards it to a laboratory.
  • the transport medium enables an analysis of the type and number of microorganisms in the test person's oral cavity without the number of microorganisms and the relative frequency of the different species during the period, which usually lasts several hours, between taking the sample early in the morning and the microbiological determination changes. It is expressly emphasized that the transport medium mentioned is not a nutrient medium, because a significant change in the number of bacteria, which is typical for nutrient media, must not occur.
  • test method according to the invention it is possible to determine the type and concentration of the microorganisms in the oral cavity without the test result being falsified by the presence of fresh saliva.
  • an examination can only be carried out by the dentist taking plaque from the interdental space and having it examined.
  • the known method has the disadvantage that the microbiological conditions are only examined at a specific point in the mouth.
  • the method according to the invention enables these conditions to be detected in the entire oral cavity without interference from fresh saliva flow.
  • the analysis can be carried out using known microbiological methods.
  • a microbiological laboratory determines the type and / or number of materials on / in the absorbent material microorganisms and the results obtained determine the risk of caries.
  • the firm, predetermined absorption capacity of the absorbent material for the saliva of the test subject is important in the method according to the invention.
  • the subject preferably dissolves a substance that stimulates the metabolism of the microorganisms of the oral cavity, in particular a sugar-like substance or other carbohydrates, or a corresponding composition of substances in his oral cavity before he strokes the absorbent material over the surface of his oral cavity, the substance or the said composition of substances is selected so that he / she does not influence the flow of saliva, so that the microorganisms are not disturbed by the antibacterial activity of the fresh saliva.
  • the invention also relates to a test device for sampling, which is particularly suitable for carrying out the method according to the invention, for determining the risk of caries in a human or animal subject, with a sterile-packed elongated carrier which has a sterile absorbent material, in particular dry medical cotton wool, at one end , wearing.
  • the absorbent material consists of cotton.
  • a reclosable container which contains a sterile transport medium. holds and is suitable for receiving the carrier with the absorbent material, the other end of the carrier being designed as a grip part which, after the container containing the carrier and the absorbent material has been closed, is located outside the container.
  • Contamination of the saliva contained in the absorbent material with foreign germs during sampling is avoided by the carrier mentioned, since the medical layperson is not tempted to touch the absorbent material with his hands.
  • the subject will rather grasp the carrier by the handle part, which cannot come into contact with the transport medium.
  • the suitability of the reclosable container for holding the carrier is important for convenient and quick introduction of the sample from the oral cavity into the transport medium.
  • sterile aids for stripping the absorbent material from the carrier are not necessary according to the invention. In this way, contamination of the sample between removal from the oral cavity and introduction into the transport medium is avoided even by the untrained layperson during the sampling, without special additional measures being necessary.
  • the container contains a sponge which is impregnated with the transport medium and on which the absorbent material rests when the carrier is introduced into the container. Damage to the surface of the absorbent material by immersing the carrier in a viscous transport medium and detaching individual material particles with adhering microorganisms from the carrier, which could possibly falsify the laboratory result, does not occur in this case with certainty.
  • the absorbent material has certain, predetermined absorption capacity for saliva, which is in particular 0.8 to 1.2 ml of saliva with an absorption period of about 2 minutes.
  • the handle part of the carrier is designed as a closure cap for the reclosable container.
  • the test person To introduce the sample into the transport medium, it is therefore only necessary for the test person to open the container for the transport medium and to insert the carrier with the absorbent material into this container. Since it only touches the cap and thus avoids contact with the absorbent material and with the other parts of the carrier, there is a high level of security against contamination of the sample with foreign germs.
  • the carrier with the sterile absorbent material must also be sterile packed before use, it is preferred if the carrier with the absorbent material is packaged in a second container, this container being tightly sealed by the said cap.
  • the subject who can be a layperson with a wide variety of skills and training, is relieved of the necessity, even with very clumsy handling, of the parts of the carrier that come into contact with the transport medium or the inside touch the container with your hands.
  • the closure cap protrudes from the container opening when the container is closed.
  • the transport medium for microorganisms is preferably intended and suitable for gram-negative, gram-positive and anaerobic bacteria.
  • the transport medium in particular contains 0.01 to 0.1% by weight K 2 HP0 4 , 0.01 to 0.1% by weight KH 2 P0 4 ,
  • the mixture preferably has a pH of 7.3 ⁇ 0.1 at 25 ° C.
  • the mixture can still be a
  • Redox indicator can be added, such as methylene blue or resaminin, which shows through its discoloration whether the transport medium contains oxygen.
  • Redox indicator can be added, such as methylene blue or resaminin, which shows through its discoloration whether the transport medium contains oxygen.
  • selectively acting antimicrobial additives such as vancomycin, kanamycin, nystatin or trimethoprim can be brought in as contamination by incorrect sampling.
  • the carrier is preferably coated with a mass which is soluble in saliva and which stimulates the metabolism of the microorganisms, in particular a sugar-like substance or other carbohydrates, and optionally also a sugar substitute, the mass being chosen such that it does not influence the flow of saliva.
  • a starch content is particularly advantageous since it does not stimulate the flow of saliva. The addition causes a weak supply of nutrients, which obviously favors the persistence of the pathogens, but without initiating growth and thus propagation.
  • the mass is preferably designed as a covering for the absorbent material, the covering completely enclosing the absorbent material.
  • the absorbent material only absorbs the saliva and the microorganisms present in the oral cavity when part of the coating or even the entire coating has dissolved and thus a certain waiting time has passed in which the microorganisms wait for the ingredients of the mass in the have responded as desired.
  • composition and amount of the mass have been selected such that, when the mass is completely dissolved by the saliva, the minimum time period for triggering the reaction of the microorganisms has passed. If the subject therefore determines that the mass has completely dissolved, the carrier can be removed and placed in the container with the transport medium.
  • composition and amount of the mass should be chosen so that it dissolves in the oral cavity for a period of 1 to 10 minutes, preferably 2 to 5 minutes.
  • layer (coating) consists of a mass which is composed essentially of the ingredient which stimulates the metabolism of the microorganisms and fat as a binder. Such a coating is to be applied to the absorbent material in a particularly economical manner in the mass production of the test device.
  • sucrose 2 to 10% by weight of sucrose
  • Starch consists of 0.2 to 0.3% by weight.
  • the mass is preferably designed as a coating for the absorbent material with a thickness of 0.1 to 0.5 mm, in particular 0.1 to 0.2 mm. This configuration ensures that a waiting time of 2 to 5 minutes has been observed after the coating has completely dissolved.
  • the acceptance of the test device by the consumer is improved if the mass also contains flavorings.
  • the aromas of lemon, lime, peppermint and eucalyptus are examples.
  • a wooden test stick, the carrier 1, has a cotton ball 2, the absorbent material, at one end, the upper end in the figure.
  • the medical cotton is coated with a neutral, pleasant-tasting mass 4 that does not promote saliva secretion.
  • the test stick is inserted into a glass tube 5 after the saliva has been removed.
  • a closure cap 6 with two ring-shaped sealing lips 7, one behind the other, formed on an inner sleeve 3, is connected to the end of the test stick 1, which lies opposite the cotton ball 2.
  • the closure cap 6 protrudes about 10 mm beyond the opening 8 of the glass tube 5 to form a comfortable grip surface.
  • the resealable container 5 provided in the test device also contains a transport medium 10.
  • a sponge soaked with the transport medium can be provided on the bottom of the container, on which the end of the transport medium
  • Test stick is on.
  • the container 5 is secured with the closure cap 6 in an airtight and liquid-tight manner.
  • the transport medium is composed as follows: 0.045% by weight K 2 HP0 4 ,

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pathology (AREA)
  • Urology & Nephrology (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Afin d'utiliser un matériau absorbant stérile ayant une capacité d'absorption prédéterminée fixe et un milieu de transport particulièrement stérile, dans le but de déterminer de manière particulièrement simple et économique et néanmoins très précise le risque de caries chez la personne qui se soumet au test, il est prévu: a) que la personne concernée badigeonne le matériau absorbant, au réveil, sur l'ensemble de la surface de sa cavité buccale; b) qu'elle place le matériau absorbant dans la solution nutritive et c) qu'à cette occasion, le type et/ou le nombre de micro-organismes présents dans le matériau absorbant soit déterminé(s) et que le risque de caries soit déterminé sur la base des résultats obtenus.
PCT/EP1997/006214 1996-11-16 1997-11-08 Procede d'utilisation pour determiner le risque de caries et dispositif de test particulierement adapte a cet effet WO1998022025A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP97951153A EP0952787A1 (fr) 1996-11-16 1997-11-08 Procede d'utilisation pour determiner le risque de caries et dispositif de test particulierement adapte a cet effet
AU54801/98A AU5480198A (en) 1996-11-16 1997-11-08 Application to determine the risk of tooth decay and a test device especially suited thereto

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1996147545 DE19647545A1 (de) 1996-11-16 1996-11-16 Verwendung zum Bestimmen des Kariesrisikos und dazu besonders geeignete Testeinrichtung
DE19647545.7 1996-11-16

Publications (1)

Publication Number Publication Date
WO1998022025A1 true WO1998022025A1 (fr) 1998-05-28

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ID=7811933

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1997/006214 WO1998022025A1 (fr) 1996-11-16 1997-11-08 Procede d'utilisation pour determiner le risque de caries et dispositif de test particulierement adapte a cet effet

Country Status (4)

Country Link
EP (1) EP0952787A1 (fr)
AU (1) AU5480198A (fr)
DE (1) DE19647545A1 (fr)
WO (1) WO1998022025A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2355525A (en) * 1999-10-18 2001-04-25 Marshall Fraser Denis Sampling device for oral cavity
WO2002006820A3 (fr) * 2000-07-14 2002-06-27 3M Espe Ag Procede pour effectuer une analyse de salive

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102005056293A1 (de) * 2005-11-24 2007-05-31 Wolfgang Arnhold Verfahren und Vorrichtung zum Erkennen von Karies
GB2440353B (en) * 2006-07-25 2011-03-30 Cozart Bioscience Ltd Oral fluid collection device, system and method
NL2006597C2 (nl) * 2011-04-13 2012-10-16 Hessels & Grob B V Systeem en werkwijze voor het verkrijgen van lichaamsvloeistof monsters, in het bijzonder urine monsters, en een houder voor het houden van een absorptiefilter in een container.
DE102020133734A1 (de) 2020-12-16 2022-06-23 Drägerwerk AG & Co. KGaA Sammelvorrichtung für eine Probenahme, sowie Verfahren für eine Durchführung einer Probenahme von biologischem Material

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DE3632303A1 (de) 1985-09-23 1987-04-02 Sarstedt Kunststoff Verfahren zum gewinnen von menschlichem speichel
GB2189398A (en) * 1986-04-25 1987-10-28 Chesebrough Ponds Oral hygiene swab
US4817632A (en) * 1987-06-23 1989-04-04 Bioquant, Inc. Oral fluid collection article
EP0418739A1 (fr) 1989-09-21 1991-03-27 Epitope, Inc. Captage d'immunoglobulines orales pour l'immunoessai
WO1992016842A1 (fr) 1991-03-12 1992-10-01 La Mina Ltd. Procede et dispositif d'essai a la salive et d'identification par empreintes digitales
WO1995002822A1 (fr) 1993-07-14 1995-01-26 Cortecs Limited Dispositif d'essai
WO1995002996A1 (fr) 1993-07-19 1995-02-02 Saliva Diagnostic Systems, Inc. Dispositif d'echantillonnage et systeme assurant la conformite de l'echantillon
WO1995027205A1 (fr) 1994-03-30 1995-10-12 Epitope, Inc. Dispositif et procede de dosage de la salive
WO1995030484A1 (fr) 1994-05-09 1995-11-16 Angelo Joseph P D Systeme de prelevement d'echantillon de salive
WO1996018902A1 (fr) 1994-12-16 1996-06-20 M & M Dental-Medizin Gmbh Trousse d'essai pour analyse de fluides organiques, procede pour sa fabrication et mode operatoire d'analyse

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JPS56120623A (en) * 1979-05-21 1981-09-22 Sunstar Inc Composition for testing caries activity of teeth
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JPS57189695A (en) * 1981-05-15 1982-11-22 Showa Yakuhin Kako Kk Culture medium composition
JPS58225029A (ja) * 1982-06-21 1983-12-27 Showa Yakuhin Kako Kk う蝕簡易判別用具
US4976951A (en) * 1985-08-28 1990-12-11 Melvyn Rosenberg Dental caries diagnostic and localization technique
US5270174A (en) * 1987-04-03 1993-12-14 Assif Science And Technology Projects Development Ltd. Method and kit for indicating the level of oral microbial activity
US5374538A (en) * 1989-03-01 1994-12-20 Orion-Yhtyma Oy Method and kit for detection or quantification of streptococcus mutans and streptococcus sobrinus
GB2250817A (en) * 1990-12-12 1992-06-17 Naresh Gathani Dental caries diagnostic floss.
US6423550B1 (en) * 1995-03-30 2002-07-23 Ortho Pharmaceutical Corporation Home oral fluid sample collection device and package for mailing of such device

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3632303A1 (de) 1985-09-23 1987-04-02 Sarstedt Kunststoff Verfahren zum gewinnen von menschlichem speichel
GB2189398A (en) * 1986-04-25 1987-10-28 Chesebrough Ponds Oral hygiene swab
US4817632A (en) * 1987-06-23 1989-04-04 Bioquant, Inc. Oral fluid collection article
EP0418739A1 (fr) 1989-09-21 1991-03-27 Epitope, Inc. Captage d'immunoglobulines orales pour l'immunoessai
WO1992016842A1 (fr) 1991-03-12 1992-10-01 La Mina Ltd. Procede et dispositif d'essai a la salive et d'identification par empreintes digitales
WO1995002822A1 (fr) 1993-07-14 1995-01-26 Cortecs Limited Dispositif d'essai
WO1995002996A1 (fr) 1993-07-19 1995-02-02 Saliva Diagnostic Systems, Inc. Dispositif d'echantillonnage et systeme assurant la conformite de l'echantillon
WO1995027205A1 (fr) 1994-03-30 1995-10-12 Epitope, Inc. Dispositif et procede de dosage de la salive
WO1995030484A1 (fr) 1994-05-09 1995-11-16 Angelo Joseph P D Systeme de prelevement d'echantillon de salive
WO1996018902A1 (fr) 1994-12-16 1996-06-20 M & M Dental-Medizin Gmbh Trousse d'essai pour analyse de fluides organiques, procede pour sa fabrication et mode operatoire d'analyse
DE4444764A1 (de) * 1994-12-16 1996-06-20 Moell Claus Juergen Testset zur Analyse von Körperflüssigkeiten, Verfahren zu seiner Herstellung und Analyseverfahren

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2355525A (en) * 1999-10-18 2001-04-25 Marshall Fraser Denis Sampling device for oral cavity
WO2002006820A3 (fr) * 2000-07-14 2002-06-27 3M Espe Ag Procede pour effectuer une analyse de salive
AU2001285805B2 (en) * 2000-07-14 2006-02-09 3M Espe Ag Method for carrying out a saliva analysis

Also Published As

Publication number Publication date
AU5480198A (en) 1998-06-10
EP0952787A1 (fr) 1999-11-03
DE19647545A1 (de) 1998-05-20

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