AU752223B2 - Methods and apparatus for the detection of dental caries - Google Patents

Description

P/00/011 28/5/91 Regulation 3.2

AUSTRALIA

Patents Act 1990

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT Name of Applicant: Actual Inventors Address for service is: The University Court of the University of Dundee Nigel Berry PITTS, Christopher LONGBOTTOM and Przemyslaw LOS WRAY ASSOCIATES 239 Adelaide Terrace Perth, WA 6000 Attorney code: WR Invention Title: "Methods and Apparatus for the Detection of Dental Caries" Details of Associated Application No: 27816/97 The following statement is a full description of this invention, including the best method of performing it known to me:- 1/i 1 "Methods and Apparatus for the Detection of Dental 2 Caries" i 3 4 This invention relates to methods and apparatus for use in detecting dental caries i.e. dental decay, or 6 "caries" or "carious lesions") by electrical and/or 7 electronic means.

8 9 Caries is defined as the progressive decay of tooth or bone, and dental caries is the most common ailment S11 known world wide. Dental caries can be treated by 12 either removing the decayed material in the tooth and 13 filling the resultant space with a dental amalgam, or 14 in severe cases, by removal of the entire tooth.

16 The early diagnosis of dental caries is of utmost 17 importance to any subsequent treatment since by the 18 time pain is felt due to decay of the tooth, the 19 treatment required to restore the tooth may be 20 extensive and in some cases, the tooth may be lost.

21 22 Historically, the diagnosis of dental caries has been 23 primarily visual, frequently accompanied by tactile 24 examination using a mechanical probe. The patient may only seek an examination by a dental surgeon when in 2 1 pain due to the caries and the surgeon must then 2 identify the offending tooth by visual examination 3 and/or by use of a mechanical probe which causes 4 discomfort or pain in the decayed tooth. This experience is painful and distressing for the patient 6 and acts as a disincentive to regular visits to the 7 surgeon for routine examinations. In addition, the 8 diagnosis of caries at this late stage of decay reduces 9 the available options for treatment.

11 The diagnosis of caries by convent onal techniques has 12 become increasingly difficult. This is a result of 13 several factors, including apparent changes in the 14 morphology and in the rate of progress and distribution of carious lesions, as well as the inaccessibility of 16 approximal (mutually contacting) dental surfaces and 17 the complicated anatomy of pit and fissure sites on the 18 occlusal (biting) surfaces.

19 An additional problem with conventional techniques is 21 that decay on the approximal surface of the tooth 22 resulting from plaque on the inter dental spaces may 23 not be detected by simply prodding the tooth, since the 24 approximal surfaces may not be reached by the probe.

The limitations of conventional visual, tactile and 26 radiographic diagnosis are well recognised. Decay may 27 progress to an advanced stage on both occlusal and 28 approximal sites without being detected until 29 substantial tooth destruction has occurred.

31 In response to these generally unsatisfactory and 32 unreliable methods of diagnosis attempts have been made 33 to develop electrical/electronic means for the 34 diagnosis of caries.

36 Electronic Caries Detectors (ECD's) generally comprise 1 a probe having a first, probe electrode which is placed 2 in contact with the tooth to be tested, and a second, 3 counter electrode separate from the probe which is 4 placed in contact with another part of the body of the patient in order to complete an electrical circuit 6 connecting the two electrodes. The second electrode 7 may be held by the patient or may be placed in contact 8 against the gingiva (gum) or oral mucosa (inside 9 cheek). An alternating electric current of fixed 10 frequency is passed through the tooth and the 11 resistance to this is measured. This electrical 12 12 resistance has been found to correlate approximately 13 inversely with the extent of caries in the tooth. The 14 technique may involve measurement at a single point on the surface of the tooth, or the use of an electrically 16 conductive paste, providing a measurement for the 17 surface as a whole.

18 19 The configuration of conventional designs of ECD probes are such that they cannot contact approximal tooth S 21 surfaces, and therefore cannot detect approximal caries 22 which does not extend to the occlusal or free smooth 23 surfaces of the tooth. No satisfactory means to detect :24 such approximal caries is currently known, although the 25 problem of approximal caries has been prevalent for 26 many years. Hitherto, the most accurate method of 27 diagnosing approximal caries has been bitewing 28 radiography, but this method is only about 29 accurate and requires the use of ionising radiation.

31 Even where good electrical contact can be established 32 between the probe electrode and the relevant site, 33 conventional ECD apparatus is of limited usefulness in 34 the detection of caries.

36 Among the objects of the various aspects of the present -4invention are the provision of: improved apparatus and methods for the electrical/electronic diagnosis of dental caries of all types; electrical/electronic probes for the detection of approximal caries; and improved electrical/electronic probes for the assessment of the occlusal and free smooth surfaces of the tooth.

In accordance with a first aspect of the invention there is provided a method for use in the detection of dental caries using an apparatus hereinafter, comprising the steps of placing said at least one probe electrode in electrical contact with an approximal surface of a patient's tooth, placing a second electrode in electrical contact with another part of the body of the pbtient, passing an alternating electrical current between said probe and second electrodes, and measuring the electrical impedance between the electrodes to said electrical current; wherein the frequency of said alternating current is varied over a predetermined frequency range and the electrical impedance is measured for a plurality of frequency values within said range.

In the preferred embodiment of the invention, the impedance measurement and corresponding frequencies are analysed by means of an alternating current impedance spectroscopy technique (ACIST) and a diagnosis of the tooth is •.:"°based on the form of the impedance spectrum obtained thereby. The measurement frequencies in the range and the number of frequencies at which S 20 impedance measurements are made are selected on the basis of the type, size and configuration of the probe electrode(s), the specific tooth surface(s) and/or .site(s) being contacted and whether or not the tooth has previously been restored (filled).

O The probe electrode may comprise an array of miniature electrodes, enabling simultaneous or sequential impedance measurements to be made at multiple sites on one or more surfaces of the tooth.

Preferred forms of apparatus for us in the method, including preferred types of probe electrodes for approximal and other tooth surfaces, are as defined below in relation to further aspects of the invention and as described more fully in the following description of embodiments of the various aspects of the invention.

In accordance with a second aspect of the invention, there is provided an apparatus for use in the detection of dental caries, said apparatus comprising: at least one probe electrode adapted to be placed in electrical contact with an approximal surface of a patient's tooth, a second electrode adapted to be placed in electrical contact with another part of the body of the patient, an alternating current source adapted for passing an alternating electrical current between said probe and second electrodes, and impedance measurement means for measuring the electrical impedance between the electrodes to said electrical current; wherein said alternating current source is a variable frequency alternating current source whereby the frequency of the alternating current applied to the tooth may be varied over a predetermined frequency range and the impedance measurement means is adapted to measure impedances corresponding to a plurality of frequency values within said range, wherein the at least one probe electrode comprises a substrate of electrically insulating material, and at least one electrode of electrically conductive material disposed on at least one surface of said substrate.

In accordance with a third aspect of the invention, 0* *o 1 there is provided a probe electrode device for use in 2 the electrical/electronic detection of dental caries, 3 comprising a substrate of electrically insulating 4 material, and at least one electrode of electrically conductive material disposed on at least one surface of 6 said substrate.

7 8 Preferably, said substrate comprises a generally 9 planar, flexible, hydrophobic material, preferably PTFE, and most preferably Goretex. Where the device is 11 intended for examination of approximal tooth surfaces, 12 said substrate is sufficiently thin to fit between the 13 approximal surfaces of adjoining teeth.

14 In certain embodiments of the third aspect of the 16 invention, said at least one electrode comprises a 17 layer of electrically conductive material applied to 18 said substrate, preferably carbon impregnated PTFE, and 19 most preferably carbon impregnated Goretex. In other 20 embodiments, the electrodes comprise corrosion- 21 resistant metal or other conductive material, such as 22 carbon. The substrate may further include a strip of 23 absorbent or hydrophobic material extending along at 24 least one edge thereof.

26 In certain preferred embodiments, the probe device 27 includes a plurality of electrodes located on said 28 substrate. Said plurality of electrodes are preferably 29 embedded in and project from said substrate. The electrodes may take the form of bands or disks, and are 31 adapted for connection to the measurement circuit of a 32 caries detection system either individually, 33 collectively or in predetermined groups. The substrate 34 is preferably connected to a holder/contact means, adapted to provide electrical connection between said 36 electrodes and a measurement circuit. In one 1 embodiment, the substrate is tapered in transverse 2 cross section and includes a tapered core portion of 3 compressible material, electrodes being provided on 4 both opposite surfaces of said substrate.

6 Preferably, said plurality of electrodes are arranged 7 in an array on said substrate. Most preferably, the 8 width or diameter of said electrodes and the spacing 9 between adjacent electrodes is in the range 0.5n to 200pm.

11 12 In accordance with a fourth aspect of the invention, 13 there is provided a dental caries detection system 14 comprising apparatus in accordance with the second aspect of the invention and at least one probe 16 electrode device in accordance with the third aspect of 17 the invention. The system is preferably adapted to 18 perform dental caries detection in accordance with the 19 method of the first aspect of the invention.

21 Other aspects and preferred features of the invention 22 are discussed in the following description of examples 23 of the invention.

24 Embodiments of the invention will now be described, by 26 way of example only, with reference to the accompanying 27 drawings, in which: 28 29 Fig. 1 is a schematic block diagram illustrating a caries detection system embodying the invention; 31 32 Fig. 2 is a graph showing plots of impedance 33 values at varying frequencies for three sample 34 teeth having different degrees of decay; 36 Fig. 3 is a plan view of one side of an approximal 1 probe electrode for use in a caries detection 2 system such as that of Fig. 1, embodying a further 3 aspect of the invention; 4 Fig. 4 is an end view of the electrode of Fig. 3; 6 7 Figs. 5(a) and 5(b) are, respectively, end and 8 front views of a first embodiment of a microprobe 9 array embodying a further aspect of the invention; 11 Figs. 6(a) and 6(b) are, respectively, end and 12 front views of a second embodiment of a microprobe 13 array embodying said further aspect of the 14 invention; 16 Fig. 7 is a front view of a third embodiment of a 17 microprobe array embodying said further aspect of 18 the invention; 19 Figs. 8(a) and 8(b) are,'respectively, end and 21 front views of a seventh embodiment of a 22 microprobe array embodying said further aspect of 23 the invention, configured for use on occlusal 24 tooth surfaces; 26 Fig. 9 is a front view of an eighth embodiment of 27 a microprobe array embodying said further aspect 28 of the invention, configured for use on occlusal 29 tooth surfaces; 31 Fig. 10 is a front view of a ninth embodiment of a 32 microprobe array embodying said further aspect of 33 the invention, configured for use on occlusal 34 tooth surfaces; 36 Fig. 11 is an end view of a tenth embodiment of a 1 microprobe array embodying said further aspect of 2 the invention, configured for use on occlusal 3 tooth surfaces; 4 Fig. 12 is a schematic isometric view illustrating 6 a first holder/contact unit for use with the 7 microprobe arrays of Figs. 5 to 13.

8 9 Fig. 13 is a schematic isometric view illustrating a second holder/contact unit for use with the 11 microprobe arrays of Figs. 5 to 13.

A

12 13 Referring now to the drawings, a basic caries detection 14 system in accordance with the invention comprises a first "probe" electrode (or array of electrodes, as 16 shall be discussed further below) 10, a second 17 "counter" electrode 12, a variable frequency 18 alternating current source 14 and impedance 19 measurement means 16, connected in series as shown with an open circuit between the probe and counter S21 electrodes, and data processing and control means 18 22 connected to receive data from the impedance 23 measurement means 16 and to control the operation of 24 the a.c. source 14.

26 The probe electrode 10 is adapted to be placed in i 27 electrical contact with the surface of the tooth which 28 is to be examined and the counter electrode 12 is 29 adapted to be placed in electrical contact with another part of the body of the patient, as discussed above, 31 completing the circuit so that the impedance 32 measurement means 16 measures the impedance between the 33 two electrodes.

34 In use of the apparatus, the a.c. source 14 applies a 36 predetermined voltage across the electrodes 10,12 so 1 that the current flowing in the circuit varies with the 2 impedance between the electrodes. This impedance is 3 measured by the impedance measurement means 16. During 4 examination of a tooth, the frequency of the a.c.

source 14 is varied over a predetermined range and 6 impedance measurements are recorded for a number of 7 frequencies within the range.

8 9 The impedance measurements are analyzed by the data processing means. In accordance with the preferred 11 embodiment of the invention the analysis comprises an 12 a.c. impedance spectroscopy technique (ACIST).

13 Suitably, the measurement frequencies are in the range 14 up to 500 kHz. The lower and upper frequencies in the range and the number of frequencies at which impedance 16 measurements are made may be selected on the basis of 17 the type, size and configuration of the probe 18 electrode(s), the specific tooth surface(s) and/or 19 site(s) being contacted and whether or not the tooth has previously been restored.

21 22 The use of ACIST in detecting dental decay was tested 23 using a sample of teeth consisting of 26 unrestored, 24 extracted premolar teeth, with varying degrees of carious lesions in their approximal surfaces. The 26 individual approximal surfaces were assigned to one of 27 three groups on the basis of their direct visual 28 appearance: sound if no visible sign of caries was 29 apparent; lesion where white or brown spot lesions (indicative of demineralization due to caries) were 31 evident with no detectable loss of surface enamel; and 32 cavitated if there was a carious lesion with an 33 area where there was obvious loss of surface enamel.

34 For each group, ten tooth surfaces were measured.

Subsequent to measurement, the teeth were hemisectioned 36 and serially sectioned to validate the visual 1 categorisation of the teeth and to determine the true 2 extent of any caries in enamel or dentine.

3 4 For these experimental purposes, the a.c. impedance measurements were carried out with the teeth placed in 6 a custom-built perspex chamber. Each tooth was 7 positioned in such a way that one of its approximal 8 surfaces was facing an aperture in the chamber, through 9 which the probe electrode, consisting of a stainless steel rod with a suitable electrically conducting 11 material (discussed further below) at the tip, could be 12 inserted to touch the surface of the tooth. A platinum 13 counter electrode was used, the circuit being 14 completed using K-Y lubricating jelly (Johnson Johnson) as a conducting gel between the counter 16 electrode and the root of the tooth. Each test tooth 17 was held in wax at the base of the chamber.

18 19 Measurements were carried out using a computercontrolled Solartron Frequency Response Analyzer (FRA) 21 1255 connected to the cell via either a Solartron 22 Potentiostat 1286 or EG&G 181 amplifier. The latter 23 configuration was used for high impedance (>IMP2) 24 measurements. Impedance measurements were carried out 25 over a wide range of frequencies, typically from 300kHz 26 to 1 Hz. At least six measurements were carried out on 27 each of the teeth to establish reproducibility of the 28 results.

29 30 The results of the measurements of a representative 31 tooth from each of the three categories S, L and C are 32 shown in the graph of Fig. 2, where the impedance 33 measured at each frequency for each of the three 34 representative tooth samples are plotted on the complex plane. The values of the imaginary impedance are 36 plotted against the real impedance Three impedance 1 "spectra" were thus obtained for the three sample 2 teeth, labelled S, L and C on the graph. The plot for 3 the group C tooth is enlarged in the inset, for 4 clarity. The distance of each point from the origin of the graph represents the magnitude of the impedance and 6 the angle subtended with the x-axis represents the 7 phase angle 8.

8 9 The electrical response of any material can be represented by an equivalent electrical circuit 11 consisting only of resistors and gapacitors. In this 12 particular case the equivalent circuit consists of four 13 components: two resistors and two capacitors. The 14 component representing the bulk resistance is connected in parallel with the capacitor representing the bulk 16 capacitance. The second resistance is connected in 17 parallel with a constant phase element, the impedance 18 of which is given by Aw-n-jBW n, where A, B and n are 19 constants and w 2nf, where f is the frequency of the sinusoidally varying voltage.

21 22 The complex impedance data were analyzed using the 23 computer program "Z Plot" (Solartron Instruments).

A

24 series of initial experiments were carried out to S 25 establish the contribution of the electrodes, gel, 26 contacts and leads. These were found to be negligible 27 in comparison with the impedance of the teeth.

28 29 The equivalent circuit derived for use in the experiments was fitted to the measurement data using a 31 non-linear least-squares procedure. In Fig. 2, the 32 solid lines represent the best fit obtained, and the 33 dots represent the data. The scale of the differences 34 in the in the electrical responses of the teeth in each of the three histological categories S, L and C is 36 readily apparent.

1 The mean values (with standard deviations) for the 2 total resistances in MQ (the sum of the two resistances 3 in the equivalent circuit), for each of the three 4 groups were: Sound, S 53.47 11.2) 6 Lesion, L 3.73 2.58) 7 Cavity, C 0.31 0.18).

8 The impedance values for each of the three groups 9 differ by an order of magnitude from the other two groups. The S group had values in the range 37-77 MQ, 11 compared with L group values in the range 0.9-10 M2 and 12 C group values in the range 76-5591 k2.

13 14 Following the ACIST measurements, the approximal aspects of the teeth that were measured were 16 photographed before hemisection of the teeth in the 17 mesio-distal plane. The hemisections were examined 18 under X2.5 and X10 magnification in a stereomicroscope, 19 using reflected light, to assess the extent of caries.

Photographs were taken of each hemisection and the 21 teeth subsequently serially sectioned to produce 120pm- 22 thick sections, which were then viewed microscopically 23 and scored for caries, and assigned to one of the 24 groups S, L and C for comparison with the results of 25 the ACIST analysis.

26 S 27 It can be seen from Fig. 2 that the impedance 28 measurements for each of the three classes of teeth, S, 29 L and C, fall into three quite distinct groups which 30 corresponded exactly with the results of the subsequent 31 microscopic examination of the teeth. Reproducibility 32 of these results was excellent.

33 34 This study shows that the "total" resistance of teeth as derived from a.c. impedance spectroscopy 36 measurements is highly correlated with the presence and 1 extent of decay in the teeth, as validated by 2 histological examination.

3 4 The results show that the accuracy of the a.c impedance spectroscopy technique in this study was effectively 6 100%, in terms of both sensitivity and specificity.

7 8 The experimental technique used in this "in vitro" 9 study can be transferred with minimal modification to "in vivo" use, thereby providing the basis for a system 11 for clinical use having substantially higher accuracy 12 than current methods of caries diagnosis.

13 14 The necessary a.c. source, impedance measurement means and control and data processing means may be integrated 16 and/or packaged in any one of a number of ways for 17 clinical use. It will be understood that the block 18 diagram of Fig. 1 is primarily for illustrative 19 purposes and does not necessarily reflect the physical arrangement of the components of a practical, clinical 21 system.

22 23 Besides the basic methodology, hardware and software 24 required to apply an ACIST approach to caries a 25 detection, the other main requirement for a clinical 26 system is the provision of probe electrodes configured 27 and optimised for "in vivo" use in order to enable 28 examination of all of the relevant approximal, occlusal 29 and free smooth surfaces of the teeth.

31 There will now be described a preferred embodiment of 32 an approximal probe electrode in accordance with a 33 further aspect of the invention.

34 Referring now to Figs. 3 and 4, a probe electrode 110 36 for use in examining the approximal surfaces of teeth 1 in an electrical/electronic caries detection system 2 comprises an electrically insulating substrate 120 3 having an electrically conductive portion superimposed 4 on at least a portion thereof and adapted to contact the approximal surface of a tooth when the substrate 6 is inserted between adjacent teeth.

7 8 In this example, the substrate 120 has conductive 9 portions 122 on both sides thereof, allowing the approximal surfaces of two adjacent teeth to be 11 examined without the need to remove and re-orient the 12 substrate. In this example also, the substrate 120 is 13 a generally elongate rectangle, and the conductive 14 portions 122 comprise strips of conductive material extending along the length of the substrate 120 closer 16 to one lateral edge thereof than to the other, but 17 spaced from both lateral edges. The conductive 18 portions 122 on either side of the substrate 120 are 19 electrically isolated from one another.

21 In order to be suitable for clinical use, the electrode 22 must be sufficiently thin, strong and flexible to be 23 capable of being drawn between tightly abutting 24 approximal surfaces of adjacent teeth, and must be 25 hydrophobic and capable of being made electrically 26 conductive at selected, specific locations.

27 28 A particularly preferred material meeting these 29 criteria is polytetrafluoroethylene (PTFE), which is a 30 electrically insulating but which is capable of being 31 selectively impregnated with conductive material. Most 32 preferably, the PTFE comprises a material such as that 33 manufactured and sold under the Trade Mark "Goretex".

Sa 34 In the illustrated example, the substrate 120 is formed 36 from electrically insulating PTFE material, while the 1 conductive strips 122 comprise layers of carbon 2 impregnated PTFE secured to the substrate 120. The 3 electrode is non-conductive in the area which will 4 contact the gingiva, in use, the lower lateral edge). The hydrophobic properties of PTFE aid 6 electrical isolation of theconductive electrode area 7 from oral fluids.

8 9 The probe electrode 110 in accordance with this aspect of the invention thus provides a means of making 11 isolated electrical contact with the approximal surface 12 of a single tooth, while providing electrical 13 insulation between the electrode and the gum adjacent 14 the tooth being tested. The probe electrode 110 may either be connected to a suitable, electrically 16 conducting lead forming part of the circuit of Fig. 1, 17 or else an electrode forming part of said circuit may 18 be placed temporarily in contact with that part of the 19 relevant conductive portion 122 of the probe electrode 110 which protrudes from between the teeth when 21 measurements are to be taken, the counter electrode 22 being held by the patient or being placed in contact 23 with another portion of the patient's body distant from 24 the tooth.

26 The configuration of the probe electrode 110 is such 27 that electrical current is prevented from passing 28 through adjacent teeth or through the gum, since the 29 conductive material 122 of the electrode 110 is restricted to discrete areas on the substrate 120 and 31 is insulated from the gum by the lower portion 124 of 32 the non-conductive substrate.

33 34 Carbon impregnated PTFE was used, attached to the end of a stainless steel rod, for establishing electrical 36 contact with the surfaces of the teeth in the 1 experimental tests described above in relation to Figs.

2 1 and 2. Initial "in vivo" studies using an electrode 3 in accordance with Fig. 3 produced results consistent 4 with the "in vitro" study, indicating that the required electrical isolation of the conductive portions of the 6 probe electrode from surfaces and fluids other than the 7 surface under test is achieved in an "in vivo" 8 situation.

9 Variations of the embodiment shown in Figs. 3 and 4 11 might include the conductive portions 122 being 12 restricted to specific areas, suchl as elliptical areas, 13 on the substrate, with extensions of the conductive 14 material leading to the upper lateral edge of the substrate 120 to allow connection to the circuit of the 16 detection apparatus. Also, a fluid absorbing material 17 might be attached along the lower lateral edge of the 18 substrate 120 to absorb oral fluids and assist in the 19 electrical isolation of the conductive portions 122.

21 There will now be described embodiments of a further 22 probe arrangement in accordance with still another 23 aspect of the invention.

o. ~24 This further aspect of the invention relates to the use 26 of a probe device having a number of small probe 27 electrodes ("microelectrodes" or "microprobes") 28 arranged in an array. The microprobes may be formed 29 from various possible conducting materials, such as 30 metals which are corrosion resistant in the oral *4 31 environment platinum or gold) or carbon. The 32 microprobes may take the form of wires, strips (bands) 33 or disks, sealed or embedded in an electrically o o 34 insulating carrier material. The microelectrodes may have a diameter in the range lpm to 100pm. The 36 carrier material may be rigid glass) or may be 1 formed from a thin, flexible material which can be 2 brought into intimate contact with the surface of the 3 teeth. Alternatively, the microprobes may have 4 submicrometer dimensions (approximately 106 active electrodes per square centimeter).

6 7 Microprobe arrays of this type may be used as the probe 8 of an electrical/electronic caries detection system 9 such as that of Fig. i. The system may include computer software which transforms the results of the 11 a.c. impedance measurements of the teeth into 12 information regarding their health and internal 13 structure.

14 The use of such arrays facilitates the analysis of the 16 health and structure of the teeth with great precision 17 (on the micrometer scale) taking into consideration the 18 depth and the surface of the tooth being studied. This 19 allows a three-dimensional (depth-surface) profile of the tooth to be obtained, thereby providing a map of 21 the dental caries within the tooth and facilitating the 0 22 provision of a very precise diagnosis of the health 23 status of the tooth in a painless, safe and rapid 24 manner (a few minutes per patient).

26 The arrays may include varying numbers of electrodes 27 and may be configured for application to occlusal, "S 28 approximal and free smooth surfaces of tooth crowns, as 29 well as root surfaces, of both restored and unrestored S 30 teeth. The counter electrode may be placed on the 31 unrestored or restored tooth and/or a restored portion 32 of a restored tooth being measured, or on the oral soft 33 tissues, or may be held in the hand of the patient.

34 Embodiments of such devices will be described with 36 reference to Figs. 5 13. It will be understood that 1 these drawings are for illustrative purposes only, and 2 the size, numbers and spacings of the microprobes may 3 vary considerably from the illustrations. In 4 particular, the microprobes may be substantially smaller in size, larger in number and more closely 6 spaced. Typically, the width or diameter of the 7 microprobes and of the spaces between adjacent 8 microprobes might be in the range 0.5 200gm.

9 The array design will vary according to the site being 11 contacted and the material being used for the 12 microelectrodes.

13 14 Fig. 5 shows an example of a microprobe array 210 configured particularly for use on approximal tooth 16 surfaces. In this example the microelectrodes 212 17 comprise narrow bands embedded in a carrier body 214 of 18 non-conducting material, such as resin. The 19 microprobes 212 project from the "front" (toothcontacting) surface of the carrier 214, typically by 1 21 100m, and extend to its upper edge for connection to 22 the circuit of the detection apparatus.

23 24 The carrier 214 is generally planar and rectangular in 25 shape, typically having a width of 10mm and a thickness 26 in the range 75-120pm. The length of the carrier 214 27 is sufficient to accommodate the required microprobe 28 array with spaces at either end to facilitate handling.

29 The array of microprobes 212 might typically extend 30 along a length of 5 10mm of the central portion of 31 the carrier 214. A strip of absorbent or hydrophobic 32 material 216 extends along the lower edge of the 33 carrier 214 to assist in isolating the microprobe array 34 from the gum and oral fluids and also to act as a physical compressor. Preferably, this is a strip of 36 PTFE (Goretex), which may be up to 50gm in thickness 1 and 1 2mm in width.

2 3 Figs. 6 and 7 show alternative embodiments in which the 4 microprobes comprise disks 218, 220 respectively. In Fig. 6, each microprobe 218 has an individual conductor 6 222 connecting it to the top edge of the carrier 214.

7 In Fig. 7, the microprobes 220 are connected to the top 8 edge of the carrier 214 in groups by conductors 224.

9 Microprobe arrays for use on free smooth tooth surfaces 11 can be generally similar to the approximal devices 12 shown in Figs. 5 to 6, the overall dimensions of the 13 carrier and of the actual array being varied to suit 14 the surfaces in question.

16 Figs. 8 to 11 illustrate embodiments of microprobe 17 arrays configured for use on occlusal tooth surfaces.

18 19 In the example of Fig. 8, the device 310 comprises a non-conductive carrier 314 carrying an array of 21 projecting band-type microelectrodes 312 similar to 22 those of Fig. 5. The carrier 314 is typically about 23 40pm in thickness and is connected along its top edge 24 to a holder/contact-scanner unit 316 (described further below). A tapered block 318 of compressible material 26 (preferably PTFE/Goretex) is secured to the carrier 314 27 on the opposite side thereof from the microprobes 312.

28 29 Figs. 9 and 10 show variations of occlusal devices similar to the variants of Figs. 6 and 7. In Fig. 9, 31 disk electrodes 320 are connected individually to 32 conductors 322. In Fig. 10, groups of disk electrodes 33 324 are connected in groups by conductors 326.

34 35 Fig. 11 shows a further example of an occlusal device 36 410. In this case the non-conductive carrier 414 is 1 tapered and has a central, tapered core 418 of 2 compressible material (preferably PTFE/Goretex). The 3 carrier 414 suitably tapers from about 80im to about 4 30pm. Projecting microelectrodes 412 are located on both surfaces of the carrier 414, so as to contact the 6 occlusal surfaces of upper and lower teeth 7 simultaneously. The microelectrodes 412 may be of the 8 band or disk type. In the latter case they may be 9 arranged and connected as shown in either Fig. 9 or Fig. 10. The upper edge of the carrier 414 is again 11 connected to a holder/scanner unit 416.

12 13 The holder/scanner units of Figs. 8 to 11 serve to 14 facilitate handling of the devices and also provide means for connecting the various microelectrodes/ 16 conductors to the measurement circuit of the detection 17 system. The devices may be configured such that all of 18 the microelectrodes in the array are connected 19 individually, or in groups or all in common. Where connected individually in groups, holder/scanner unit 21 and/or the measurement circuit may include means for 22 connecting each electrode or group into the circuit in 23 turn for taking impedance measurements for 24 "scanning" the electrodes. Fig. 12 illustrates a 25 holder/contact unit 516 in which a common "busbar" 520 26 is arranged to contact all of the microprobes/ S27 conductors of the array. Fig. 13 illustrates a 28 holder/contact unit 616 in which individual conductors 29 620 are provided for connection to individual microelectrodes/conductors or groups of 31 microelectrodes/conductors of the array. The choice of 32 individual, group or common connection of the array can 33 be made depending upon the type of information which is 34 required from the examination.

36 For occlusal devices, the band or disk electrodes may 1 be arranged in various configurations to facilitate 2 electrical contact with the enamel of the pit and 3 fissure pattern of the occlusal surfaces (which varies 4 between individual teeth). The size of these occlusal arrays may vary in width, depth and thickness.

6 7 The computer software which processes the measurement 8 data from the microprobe arrays may transform the 9 impedance measurements into information showing analysis of the electrical resistance and capacitance 11 of the measured tooth structure. Fhis in turn is 12 transformed, by means of an experimentally derived 13 equivalent circuit, into information about the extent 14 of mineralisation and surface integrity of the tooth structure, as previously described. The actual 16 equivalent circuits derived will depend on the size and 17 configuration of the microprobe arrays used. By means 18 of the use of experimentally derived results for the 19 electrical properties of sound and diseased tooth tissue at a sub-micrometer level, a computer program 21 based on a developed three-dimensional model of tooth 22 tissue at various specific sites may be used to 23 transform the a.c. impedance data obtained during an 24 examination into a three-dimensional (depth-surface) profile of the tooth surface being measured. This may 26 provide a map of the dental caries within the tooth, 27 facilitating the provision of a very precise diagnosis 28 of the health status of the tooth.

29 The system of Fig. 1 is advantageously used with one or 31 more of the types of probe electrode device described 32 with reference to Figs. 3 to 13, providing a caries 33 detection system which may provide a reliable, 34 repeatable and accurate examination of all occlusal, 35 approximal and free smooth surfaces of teeth "in vivo".

36 1 Improvements and modifications may be introduced 2 without departing from the scope of the invention.

3 ***ee

Claims (28)

1. Apparatus for use in the detection of dental caries, said apparatus comprising: at least one probe electrode adapted to be placed in electrical contact with an approximal surface of a patient's tooth, a second electrode adapted to be placed in electrical contact with another part of the body of the patient, an alternating current source adapted for passing adapted for passing an alternating electrical current between said probe and second electrodes, and impedance measurement means for measuring the electrical impedance between the electrodes to said electrical current; wherein said alternating current source is a variable frequency alternating current source whereby the frequency of the alternating current applied to the tooth may be varied over a predetermined frequency range and the impedance measurement means is adapted to measure impedances corresponding to a plurality of frequency values within said range, wherein the at least one probe electrode comprises a substrate of electrically insulting material, and at least one electrode of electrically conductive material disposed on at least one surface of said substrate. *o

2. The apparatus according to claim 1, wherein said 25 substrate comprises a generally planar, flexible, hydrophobic material.

S3. The apparatus according to claim 2 wherein said hydrophobic material is PTFE

4. The apparatus according to claim 3 wherein said hydrophobic material is Goretex.

The apparatus to any one of claims 1 to 4 wherein said substrate is sufficiently thin to fit between the approximal surfaces of adjoining teeth.

6. The apparatus according to any one of claims 1 to wherein said at least one electrode comprises a layer of electrically conductive material applied to said substrate.

7. The apparatus according to claim 6 wherein said electrically conductive material comprises carbon impregnated PTFE.

8. The apparatus according to claim 5 or claim 6 wherein said electrically conductive material comprises carbon impregnated Goretex.

9. The apparatus according to any one of claims 1 to 6 wherein the electrodes comprise corrosion-resistant metal or other conductive material, such as carbon.

The apparatus according to any one of claims 1 to 9 wherein said substrate further includes a strip of 20 absorbent or hydrophobic material extending along at least one edge thereof.

11. The apparatus according to any one of claims 1 to wherein the probe device includes a plurality of electrodes located on said substrate.

The apparatus according to claim 11 wherein said plurality of electrodes are embedded in and project from said substrate. 30

13. The apparatus according to claim 11 or claim 12 wherein said electrodes take the form or bands or disks, and are adapted for connection to the alternating current source either individually, collectively or in -26- predetermined groups.

14. The apparatus according to any one of claims 11 to 13 wherein said plurality of electrodes are arranged in an array on said substrate.

The apparatus according to claim 14 wherein the width or diameter of said electrodes and the spacing between adjacent electrodes is in the range 0.5im to 200gm.

16. The apparatus according to any one of claims 1 to wherein said substrate is connected to a holder/contact means, adapted to provide electrical connection between said electrodes and the alternating current source.

17. The apparatus according to any one of claims 1 to 16 wherein said substrate is tapered in transverse cross section and includes a tapered core portion of compressible material, electrodes being provided on both opposite surfaces of said substrate. oooeo A.

18. The apparatus according to any preceding claim further including date processing means adapted to analyse the impedance measurements and corresponding frequencies by 0•0o means of an alternating current impedance spectroscopy technique (ACIST) in order to generate an impedance spectrum.

19. The apparatus according to any preceding claim wherein the measurement frequencies are in the range up to 500kHz. 30

20. The apparatus according to any preceding claim wherein A. the apparatus is adapted to allow selection of lower and upper frequencies in the range and the number of frequencies at which impedance measurements are made on the -27- basis of the type, said anc configuration of the probe electrode(s), the specific tooth surface(s) and/or site(s) being contacted and whether or not the tooth has previously been restored (filled)

21. The apparatus according to any one preceding claim wherein the probe electrode comprises an array of miniature electrodes, enabling simultaneous or sequential impedance measurements to be made at multiple sites on one or more surfaces of the tooth.

22. A method for use in the detection of dental caries using an apparatus according to any preceding claim, comprising the steps of placing said at least one probe electrode in electrical contact with an approximal surface of a patient's tooth, placing a second electrode in electrical contact with another part of the body of the patient, passing an alternating electrical current between said probe and second electrodes, and measuring the electrical impedance between the electrodes to said S: electrical current; wherein the frequency of said 20 alternating current is varied over a predetermined frequency range and the electrical impedance is measured :for a plurality of frequency values within said range.

23. The method according to claim 22 wherein the impedance 25 measurement and corresponding frequencies are analysed by means of an alternating current impedance spectroscopy *technique (ACIST) and a diagnosis of the tooth is based on the form of the impedance spectrum obtained thereby. oo 30

24. The method according to claim 23 wherein the measurement frequencies are in the range up to 500kHz.

25. The method according to any one of claims 21 to 24 -28- herein the lower and upper frequencies in the range and the number of frequencies at which impedance measurements are made are selected on the basis of the type, size and configuration of the probe electrode(s), the specific tooth surface(s) and/or site(s) being contacted and whether or not the tooth has previously been restored (filled).

26. The method according to any one of claims 21-25 wherein the probe electrode comprises an array of miniature electrodes, enabling simultaneous or sequential impedance measurements to be made at multiple sites on one or more approximal surfaces of the tooth.

27. Apparatus for use in the detection of -dental caries substantially as hereinbefore described with reference to the Figures.

28. A method for use in the detection of dental caries substantially as hereinbefore described with reference to 20 the Figures. Dated this Second day of July 2002. The University Court of the University of Dundee Applicant Wray Associates Perth, Western Australia Patent Attorneys for the Applicant *ooo •go