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1 Dental School and Dental Health Services Research Unit, Dental School, University of Dundee, Park Place, Dundee, DD1 4HR, Scotland, UK; and
2 Dept of Dentistry, University of Groningen, A. Deuslinglaan 1, NL 9713 AV Groningen, The Netherlands;
* corresponding author, c.longbottom{at}dundee.ac.uk
| ABSTRACT |
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KEY WORDS: caries electrical measurement caries clinical trials
| INTRODUCTION |
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| OUTLINE OF PAPER |
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In terms of the particular applicationcaries clinical trials (CCTs)the fundamental question being asked is, "Can a technique be used to measure caries to determine anti-caries effects?" Hence, what is the accuracy of the technique in measuring what it purports to measurecaries?
Factors affecting the process of data analysis also need to be considered. Only then can examination and analysis of the available data from the use of electrical measurements in CCTs thus far reported be used to help to determine whether the results can allow conclusions to be drawn about the applicability and effectiveness of the technique in CCTs. The paper will conclude by summarizing the above review and suggesting recommendations regarding electrical measurements in caries clinical trials.
| HOW DO ELECTRICAL MEASUREMENTS OF DENTAL CARIES WORK? |
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| WHAT DO ELECTRICAL MEASUREMENTS ACTUALLY MEASURE? |
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| FACTORS AFFECTING ELECTRICAL MEASUREMENTS |
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Porosity
Porosity is a somewhat ambiguous term and, in the context of the electrical measurement of teeth, could mean three slightly different things:
In relation to porosity, it is well-recognized that teeth undergo a maturation process after eruption; this process has a significant effect on porosity and hence electrical properties. There are variations in the process between and among individuals, as demonstrated recently by Schulte et al.(1999) and by Wang et al.(2001), and there is a period of up to 1518 months after eruption in which the electrical impedance characteristics of particular teeth can vary. This is of particular relevance to CCTs involving adolescents, in whom several teeth are relatively recently erupted, notably the second permanent molars.
Surface Area
The surface area of the electrode contact with the tooth is a significant factor in electrical measurements. The two modes of "site- (or point-)specific" and "surface-specific" electrodes produce different values for electrical properties, and slight but evident differences in the validation studies reported in the literature for the two techniques tend to confirm this effect.
The Thickness of the Tissues
Thickness of the tissues, especially in relation to the variation of enamel fissure thickness, will affect electrical measurements, and differences between tooth types have been demonstrated previously. More recently, analysis of data from Wang et al.(2000) suggests that within-tooth site differences can affect electrical measurements.
Hydration of the Enamel
Hydration of the enamel will affect electrical measurements. The commercially available ECM device, for example, is designed to operate with a specific air-flow, but care must be taken that the teeth are not previously dehydrated prior to measurement. The use of a contact medium of toothpaste or gel minimizes this effect to a certain extent, but again care has to be taken to standardize, as much as possible, any drying prior to the contact medium application.
Temperature
Huysmans et al.(2000) recently demonstrated that the temperature of the teeth affects the electrical values obtained, though the fact that this effect was linear simplifies in vitro to in vivo extrapolations of absolute values of parameters.
The Concentrations of Ions in the Dental Tissue Fluids
The concentrations of ions in the dental tissue fluids, particularly within enamel, are critical to electrical measurement values, yet little is known about the possible extent of the effect of variations of this on measurements in vivo. For example, will a recently consumed sugary snack initiate sufficient demineralizing activity in the surface layer and body of a lesion to alter the ionic inter-prismatic fluid concentration, hence electrical measurement values, obtained during the time of the initial pH drop in the Stephan curve?
| SINGLE- OR MULTIPLE-FREQUENCY MEASUREMENTS |
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EIS has been applied to approximal sites in vitro, and it has the potential for application to occlusal and free smooth-surface sites in vivo, with the use of suitable contact probes.
One prototype EIS device has been developedthe ACIST devicebut this is not yet commercially available. The use of a prototypethe pre-ACIST devicewas investigated on a subset of subjects in a recent clinical trial, but details are not yet available, since they are still subject to commercial confidentiality. The results will be presented in due course.
| VALIDITY |
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In terms of traditional caries thresholds used in CCTs, there are sensitivity and specificity data for D1 (enamel) caries and D3 (dentinal) caries for both site-specific and surface-specific ECM methods. For site-specific D1 measurements, the sensitivity (Se) figures from different studies range between 0.70 and 0.92, with specificity (Sp) values of 0.78 to 1.00. The equivalent figures for surface-specific measurements are 0.61 to 0.65 (Se) and 0.73 to 0.86 (Sp).
For dentinal caries, the equivalent figures for these ranges are 0.39 to 0.97 (Se) and 0.56 to 0.98 (Sp) for site-specific measurements and 0.68 to 0.78 (Se) and 0.76 to 0.90 (Sp) for surface-specific measurements.
| HOW DO THESE FIGURES RELATE TO CCTS? |
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Subjects in different CCTs may have relatively different caries prevalence and/or incidence rates at occlusal, approximal, and/or free smooth-surface sites. Thus, the usefulness of ECM measurementswhich apply to occlusal sites onlyfor a CCT may vary according to the relative occlusal to approximal to free smooth-surface caries ratios for prevalence and/or incidence in the subjects in a particular CCT site.
Thus, ECM may be useful in determining product differences in CCTs in areas with incidence rates of occlusal caries that are high relative to approximal caries, but be less useful for CCT in an area with a relatively higher approximal to occlusal caries incidence ratio. There is, of course, a less than simple relationship between total (and/or site) caries prevalence and incidence, since this depends on such factors as the age of the subjects at the time of data collection and population levels of caries.
| FACTORS AFFECTING MEASUREMENTS IN RELATION TO DATA ANALYSIS |
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Ten Bosch et al.(2000) confirmed the time-dependent decrease in the porosity of newly erupted teeth but also noted an unexpected seasonal variation in the ECM measurements on recently erupted teeth. The seasonal variations in these measurements were statistically significant, hence should be taken into account in any analysis of data collected over several months in a clinical trial environment.
Surface Area
In relation to surface area, different tooth types have different surface areas of contact. This relates particularly to "surface-specific" electrical measurements. Thus, different threshold values for electrical measurements may need to be applied to molars and premolars, respectively.
Thicknesses of Enamel
Different tooth types have different thicknesses of enamel, and such differences can occur even within tooth types; thus, ECM site measurements may need different threshold values for different sites for premolars and molars or even for occlusal and palatal/buccal sites in the same molar.
Hydration
Different hydration states of the measured teeth may occur if the measurement sequence involves holding each subjects mouth open for sufficient time for dehydration to affect the electrical measurements. This latter critical period is in reality only a matter of seconds. Thus, skewed distributions of electrical measurement data in relation to left-right side and/or upper-lower jaws may require the application of "compensatory" statistics, or modification of the measurement protocol.
Temperature
The effects of temperature appear unlikely to require statistical intervention, since mouth temperatures are likely to stay within a small range for even a large number of subjects, though extremes of climate may have a minor effect on electrical measurements.
Fluid Ionic Concentration
Although enamel fluid ionic concentration may seem, at first thought, to have minor significance, the extent to which the time at which electrical measurements are taken in relation to school breaks and hence eating patterns does not appear to have been investigated. It is difficult, in any event, to see how this could be compensated for statistically.
| LONGITUDINAL CARIES STUDIES |
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Ie et al.(1995) and Fennis-Ie et al.(1998) reported on the use of the ECM in a longitudinal study of the first and second molars of 50 children aged 57 and 1115 yrs. Comparisons were made with clinical-visual and FOTI techniques, and the teeth were monitored on six occasions at six-monthly intervalsa total of 2.5 yrs. Although the differences were reported to be very small, the authors concluded that ECM measurements were superior to FOTI and clinical-visual assessments for the prediction of occlusal caries.
| CARIES CLINICAL TRIALS |
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In the Ashley study, surface-specific electrical measurements were recorded every 6 mos during the second 18-month period of a three-year clinical trial comparing two products whose relative anti-caries effects were unknown. The second molars in 316 subjects aged 13.9 yrs at the ECM-baseline were measured and caries status for electrical measurements designated according to D1 and D3 cut-off values previously determined by laboratory studies.
The findings of this CCT were that, over the 18-month period, ECM measurements demonstrated a significant difference in the mean DFS increment between the test and the control groups at the p < 0.05 level. In contrast, the conventional detection methods used in the trial were unable to discriminate between the products over 3 yrs.
In the Vilnius study, which used two products with different effects of known extent, as shown previously by conventional detection methods, site-specific ECM measurements were recorded on all posterior teeth in 2387 subjects (aged 1114 yrs) at baseline and 12 mos, using pre-determined D1 and D3 threshold points. For analysis, the ECM data were log-transformed. No product differences were found with the ECM, but they were found with a new Clinical Visual systemthe Dundee Selectable Threshold Method (DSTM)on approximal but not occlusal surfaces.
In addition, ECM readings were found to be highly significantly tooth-dependent, with higher readings the more posterior the tooth type. ECM readings were highly significantly jaw-dependent, with mandibular teeth generally scoring higher than maxillary teeth, except for first premolars. There was also a strong relationship between the ECM scores and the Clinical Visual Assessment (CVA) scores.
With the results of only two studies published for coronal caries available for review, the results are tantalizing: The Ashley study shows a possible but not conclusive ability of ECM to discriminate between products, but it was not conclusive, since the relative anti-caries effects of the two products were not known. This study also shows the inherent scientific invalidity of using an insensitive technique (CV) as the "gold" standard for demonstrating product effects when these are compared with new detection systems.
The Vilnius study shows the need for extreme care in data analysis when electrical measurements are used. As noted above, there are many factors which can affect ECM readings. This study also illustrates the possible effect of relative occlusal to approximal caries prevalence and/or incidence ratios in the subjects on the ability of ECM to demonstrate a product effect. The prevalence of occlusal caries in Vilnius was very high. This may have reduced the relative occlusal to approximal caries incidence to a level at which, in the time-scale of the measurement points, the product effects could not be demonstrated at occlusal sites compared with approximal sites.
The only reported longitudinal study involving electrical measurements of root caries involved 186 subjects examined at baseline, 3 mos, and 6 mos. All subjects had at least one primary root caries lesion at baseline, and these lesions were assessed clinically and with the ECM. The subjects were randomly assigned to one of two groups, one using a 5000-ppm-fluoride-containing dentifrice, and the other a 1100-ppm-fluoride-containing dentifrice. After 6 mos, 57% of the subjects in the 5000-ppm-F group and 27% of those in the 1100-ppm-F group had lesions which had hardened clinically (p = 0.002). Between baseline and 6 mos, the log10 mean ± SD resistance values of lesions for subjects in the 1100-ppm-F group decreased by 0.004 ± 0.70, whereas in the 5000-ppm-F group, they increased by 0.56 ± 0.76 (p < 0.0001). The authors noted that the plaque index in the 5000-ppm-F group was significantly reduced compared with the 1100-ppm-F group. This latter difference may be a confounding factor in relation to interpreting the results, since plaque removal per se can alter the activity, hence the hardness, of root caries lesions.
| SUMMARY |
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| RECOMMENDATIONS |
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In conclusion, electrical measurements are showing early promise as a technique for the clinical detection of caries in the context of caries clinical trials. Careful analysis of current and emerging CCT data will help to determine the extent of the usefulness of the application of the method in this field.
| FOOTNOTES |
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| REFERENCES |
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Ashley PF, Ellwood RP, Worthington HV, Davies RM (2000). Predicting occlusal caries using the Electronic Caries Monitor. Caries Res 34:201203.[ISI][Medline]
Baysan A, Lynch E, Elwood R, Davies R, Petersson L, Borsboom P (2001). Reversal of primary root caries using dentifrices containing 5,000 and 1,100 ppm fluoride. Caries Res 35:4146.[ISI][Medline]
Bedinskaite R, Sabatalaite R, Gendvilyte A, Huntington E, Matuliene G, Balciuniene I, et al. (2001). Comparison of DIAGNOdent and ECM techniques with radiography for the assessment of caries (abstract). Caries Res 35:279280.
Chesters RK, Huntington E, Kvedariene A, Matuliene G, Balciuniene I, Nicholson JA, et al. (2001). Clinical visual assessment and the second permanent molar: a sensitive method for assessing anticaries efficacy (abstract). Caries Res 35:278.
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