Determination of the minimum number of marginal gap measurements required for practical in vitro testing

Martin Groten, DMD,a Detlef Axmann, Dr rer nat,a Lothar Prbster, DMD, PhD,b and Heiner Weber, DMD, PhDc University of Tbingen, Tbingen, Germany Statement of problem. Gap measurements along margins are frequently used to assess the quality of single crowns. However, the number of gap measurements required for clinically relevant results in laboratory studies is not known. Purpose. This study estimated the minimum number of gap measurements on margins of single crowns to produce relevant results for gap analysis. Methods and material. Ten all-ceramic crowns were fabricated on a master steel die. Gaps along crown margins were investigated in a scanning electron microscope on the master steel die without cementation and on replica dies after conventional cementation. Measurements were made in 100 m steps according to 3 gap definitions. The initial number of measurements per crown (n = 230) was reduced to smaller subsets using both systematic and random approaches to determine the impact on the quality of results. Results. On the data of gap definition 1, reduction from 230 to about 50 measurements caused less than 5 m variability for arithmetic means. Analysis of standard errors showed slowly increasing values smaller than 3 m, both indicating no relevant impact on the quality of results. Smaller data sizes yielded accelerated increase of standard errors and divergent variabilities of mean. The minimum of 50 measurements did not depend on gap definition or on cementation condition. Conclusion. Fifty measurements are required for clinically relevant information about gap size regardless of whether the measurement sites are selected in a systematic or random manner, which is far more than what current in vitro studies use. (J Prosthet Dent 2000;83:40-9.)

CLINICAL IMPLICATIONS
Observation on both uncemented and cemented crowns that approximately 50 measurements per marginal gap, provided acceptable results facilitates the investigation of marginal fit on single crowns. The related increase of the measurement error is of minor importance for the assessment of crowns in clinical use. On the basis of the results of this study, the chance of getting results of clinical relevance with less than 50 measurements per crown is doubtful.

he extent of misfit of dental restorations is believed to be closely associated with the development of secondary caries and periodontitis.1-6 Gap measurements at margin are frequently used to quantify fit. Few studies have evaluated the methods for measurements on single crowns.7,8 In contrast, great efforts have been made to evaluate the fit of inlays, fillings, and adhesively luted restorations, and to discuss the methods used.9-12 Little information is available on the clinical relevance of gap sizes on crowns. No general guidelines

Presented at the seventh annual meeting of the International College of Prosthodontists, Sliema, Malta, October 1997. aAssistant Professor, Dental Clinic, Department of Prosthodontics. bAssociate Professor, Dental Clinic, Department of Prosthodontics; and Private Practice, Wiesbaden, Germany, cProfessor and Chair, Dental Clinic, Department of Prosthodontics. 40 THE JOURNAL OF PROSTHETIC DENTISTRY

exist on how to perform gap measurements on crowns in vitro or in vivo. The term marginal gap does not have a single definition. An important approach to this problem was provided by Holmes et al,13 who established several gap definitions according to the contour differences between the crown and tooth margin. According to their classification, a suitable definition for the minimum gap width is the external marginal gap, the perpendicular measurement from the internal surface of the casting to the axial wall of the preparation is called the internal gap, and the same measurement at the margin is called the marginal gap.13 The actual maximum gap width, called the absolute marginal discrepancy, was defined as the angular combination of the marginal gap and the extension error (overextension or underextension).13 However, in practice it is almost impossible to describe a certain gap by only one definition, due to morphologic aberraVOLUME 83 NUMBER 1

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Fig. 1. Illustration of hypothesis regarding course of cost/benefit ratio related to research activities; contains segment of optimality, where outcome is presumably high.

Fig. 2. Flow chart maps stages of study. Boxes of steps relevant for preparatory effort are shaded.

tions, rounded margins, or defects.7 This is one of the main reasons for the large amount of variation commonly reported among investigators.14-20 Large variations or a complex gap morphology complicate attempts to measure marginal gaps. Large variations may be present; thus, it is of practical interest to determine the number of measurements necessary for determining gap sizes. The number of sites measured per crown varies considerably (ranges from 415,17,21 to 8,8 12,22 54,23 and more than 1007 sites per crown). This may also explain the dissent concerning the clinically acceptable gap size for dental restorations.2,4,15,24-26 Accuracy of measurement refers to how close the average is to the true value,27 precision refers to how close repeated measurements of the same quantity are to each other27 and power of inferences is proportionally related to the number of measurements taken. However, the limits of an admissible lack of precision are based on the projects scientific or clinical background and have to be assessed according to it.28 Therefore, it is difficult to predict the number of measurements by a standardized calculation modus. An empirical approach might be a more appropriate way. Scientific research is expensive and time-consuming. Resources are limited, so methods to reduce efforts and costs are of fundamental interest. There exists a relation (optimality)29 between methodical effort and quality of results in every research activity that follows a sigmoid-shaped curve (Fig. 1). Optimality helps to define the cost/benefit ratio for a research project. There is an initial stage with high effort but without relevant results. Likewise, after the optimal range, there is an asymptotic stage near the limit of achievable benefit, that represents excessive expenditure of resources (Fig. 1). The purpose of this in vitro study was to determine empirically the minimum number of gap measurements, required to yield clinically relevant information,
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and a consistent estimate for the gap size of single crowns.

MATERIAL AND METHOD

Ten crowns were fabricated on a master steel die and investigated twice by SEM. The marginal gap of each crown was then measured according to 3 distinguishable gap definitions. Finally, subsets of the initially recorded data were analyzed to evaluate the minimum number of gap measurements per crown (Fig. 2). A master steel die having the shape and dimension of a maxillary middle incisor15,20,21,23 was prepared following guidelines for all-ceramic crowns.30 On this die, 10 all-ceramic crowns were manufactured according to the Celay-In-Ceram technique31,32 (Mikrona AG, Spreitenbach, Switzerland, and Vita Zahnfabrik, Bad Sckingen, Germany). The restoration system, manufacturing technique, and special modifications have been described in a previous article7 and in other investigations.23,33,34 In-Ceram all-ceramic crown system was introduced in 1986 and is clinically well documented.35-37 Ten replica dies of the master steel die were produced by impressions (Provil H & L, HeraeusKulzer GmbH/Bayer Dental, Leverkusen, Germany) and molded with a epoxy resin die material (IvoclarVivadent, Schaan, Liechtenstein).39 The fit of crowns onto replica dies was controlled by a stereomicroscope (Wild M3C, Wild, Heerbrugg, Switzerland) with a magnification factor of 10 to detect major seating error or defects as a result of replication and cementation process. Eventual minor error of fit or of die dimension could be neglected because it did not affect the aims of this study. Before its replication, the master steel die had been marked with indentations of the testing pyramid of a Vickers hardness testing microscope (Orthoplan with Microhardness testing device, Leitz, Wetzlar, Ger41

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Fig. 3. Outcome variables of marginal gap measurements. A, Detail of SEM micrograph, printed as black and white photograph on which measurements were performed. Actual view on 3 examples of measurement according to different gap definitions. B, Sectional view, not in exact scale to A. Schematic illustration of 3-dimensional gap morphology that is an important source of error due to projection phenomena.

Table I. Overview SEM measurements of series I and II marginal gaps

Sample of 10 crowns Series I Series II

Noncemented on the master steel die SEM investigation of each crown on the master steel die (= specimen) and photographic documentation 10 documentations (1 per each specimen with 24 to 29 prints 9 13 cm) 10 measurements of the vertical discrepancy 1 (1 per each specimen) resulting in: 10 data sets (about 230 reference points per specimen) 5 measurements of the vertical discrepancy 2 (specimens 1 to 5) resulting in: 5 data sets (about 230 reference points per specimen) 5 measurements of the vertical discrepancy 3 (specimens 1 to 5) resulting in: 5 data sets (about 230 reference points per specimen)

Conventionally cemented on the replica dies SEM investigation of each crown on its replica die (= specimen) and photographic documentation 10 documentations (1 per each specimen with 24 to 29 prints 9 13 cm) 10 measurements of the vertical discrepancy 1 (1 per each specimen) resulting in: 10 data sets (about 230 reference points per specimen) 5 measurements of the vertical discrepancy 2 (specimens 1 to 5) resulting in: 5 data sets (about 230 reference points per specimen) 5 measurements of the vertical discrepancy 3 (specimens 1 to 5) resulting in: 5 data sets (about 230 reference points per specimen)

many) to allow for orientation and to identify the gap regions during the SEM investigations. Approximately 500 m below the cervical preparation line, 21 circular marks were indented in increments varying from about 0.7 to 2 mm. Each mark consisted of 2 to 4 diamond impressions in a characteristic configuration to identify and distinguish it from adjacent marks. During the indentation process, the die was mounted in a handpiece (INTRA Matic 10 CN, Kaltenbach & Voigt Dentale Medizinische Instrumente, Biberach/Riss, Germany) and rotated arbitrarily between 2 adjacent sites; thus, distances between adjacent marks varied. This variation in incremental distances was not in conflict with the aim of this study.
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The sample of 10 In-Ceram crowns was repeatedly examined by SEM (Stereo Scan 250, Cambridge Instruments, Cambridge, England), which was zoomed to a magnification factor of 100 according to a previous study.7 Preparation, investigation conditions, and gap measurements of the crowns are presented in Table I. In series I, final seating position of each crown on the master die was stabilized with a tiny drop of temporary cement (Temp Bond, Kerr Europe, Basel, Switzerland) on the incisal edge.7 In series II, the crowns were conventionally cemented on replica dies with capsuled zinc phosphate cement (Phosphacap, Ivoclar-Vivadent). Crowns were axially loaded during cement setting to avoid uncontrolled displacement or
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Fig. 4. Illustration of 2 approaches for data reduction on patient case. Stone model, lateral incisor was restored with Celay-In-Ceram crown (for demonstration purposes, amount of measured sites is restricted to only 60). White points, selected reference points; black rings, skipped reference points.

seating error by application of finger pressure. During the SEM investigations, the gap regions were completely documented on SEM micrographs for the entire length of each margin. All measurements were performed on the SEM micrographs after printing them in black and white at a size of 9 13 cm. Three measurement types for marginal gap were considered (Fig. 3, A and B): 1. Vertical discrepancy 1 refers to the marginal gap of Holmes et al13 and was defined from the (rounded) external crown margin to the opposite preparation line or surface at the point in shortest perpendicular distance. 2. Vertical discrepancy 2 was defined from the most external point at the (rounded) crown margin to the most external point at the (rounded) preparation margin taking rounding phenomena at the edges into account. 3. Vertical discrepancy 3 was defined from that point on the crown surface where defects, aberrations, and the exposed surface of the core material reach the smooth surface of the veneer ceramic to the most external point of the preparation. Defects and the amount of exposed coping surface after retraction of the veneer ceramic as a result of the firing process (Fig. 3, A and B) were considered, whereas defects within the veneer ceramic itself were not considered. Vertical discrepancies 2 and 3 were evaluated on 5 crowns (crowns 1 to 5) in consideration of the complex observed gap morphology (Fig. 3,B). Reference points (the sites where a gap measurement was taken) were marked on the prints. The disJANUARY 2000

tance between adjacent points was 100 m along the line between 2 successive die marks. The increment of 100 m restarted at the site of each new mark. This produced an average of 230 reference points for each crown margin. A digital precision gauge (Digi-Met Nr. 220201, Preisser, Pforzheim, Germany) was used to record measurements in millimeters up to 2 decimal places (gauge error of approximately 0.01 mm) but were rounded to 1 decimal place. The time required for measurements was also recorded by the investigator. Because of the magnification factor of the SEM and zoom factor of the black and white prints, 1 mm on the photographs (raw data) corresponded to the real gap size of 10 m. On the basis of the gauge error, the gap error by measuring with the gauge was 1 m at the worst. This amount is negligible for the assessment of real gap sizes on crowns. Repeated measurements with the gauge on the gaps by 3 raters showed an interrater agreement within 1.0 mm (10 m of real gap size) with interrater agreement of 94% on average. In contrast, variation due to repeated measurements of the vertical discrepancies 2 and 3 was far more than 1.5 mm (15 m).38 Each data set of measurements was systematically reduced in size using 2 approaches (Fig. 4). For mode 1, reference points being considered were changed from every 100 m to every 200 m, up to 2000 m (equally spaced data). In mode 2, reference points were randomly selected to decrease the numbers of
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B
Fig. 5. A, Arithmetic mean and standard error of measurement 1-3 (uncemented crown), illustrate variability due to selecting equally spaced data. Data size (number of measurements) is indicated as percentage of initial data size. B, Arithmetic mean and standard error of measurement 1-3 (uncemented crown), illustrates variability due to selecting random data. Data size (number of measurements) is indicated as percentage of initial data size.

measurements from about 230 down to about 10 per crown. Randomization was produced by JMP statistic software package (SAS Institute Inc, Cary, N.C.) (random data). The number of measurements in each new data set was first indicated as percentage of the initial 230 measurements (Fig. 5, A and B). Later on, the actual numbers of measurements related to the percentage values were calculated for each analyzed crown (namely, 50% refer to an incremental distance of about 200 m or to a number of about 115 measurements). The new data were statistically reevaluated and the results were compared with the statistical measures arithmetic mean and standard error of the mean of the initial data sets: According to the type of vertical discrepancy, tolerance limits were defined around the initial statistical measures before the analysis. All arithmetic mean and standard error values resulting from the new data had to be within these limits for being assessed as clinically relevant and consistent.
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For the vertical discrepancy 1, tolerance limits of mean values were 0.5 mm around the mean of the initial data set. The standard error of the mean should be limited to the maximum value of 0.3 mm. Thus, means outside a range of 0.5 mm around the initial mean indicated an unacceptable loss of relevant information about the gap size. If the values of standard error exceeded 0.3 mm, the estimate of the mean was no longer consistent. These predefined tolerance limits for mean and standard error values were derived from the data of previous SEM studies on the same sample of crowns7: The previous standard error value was doubled from 0.15 to 0.3 mm. The previously estimated SEM error of about 0.5 mm was doubled as well to the range of 0.5 mm. The total of the assumed upper tolerance limit for the reevaluated mean and standard error values, (0.5mean + 0.3se) = 0.8 mm respectively at the most 8 m of real gap size, seemed to be reasonable because it was still within the limits evaluated for the interrater agreement of the measurements.38 A similar level of precision (9 to 10 m) was reported by Sorensen8 for the interrater agreement of marginal gap measurements on sectioned crowns. Furthermore, the assessment of SEM accuracy requires inclusion of technical error: Variation of tilt angles on undercontoured crown margins caused projection error of up to 15%,7 which was confirmed by the present SEM investigations (Fig. 3, B). The overall error of SEM measurements will be discussed later. At this point, discussions about real gap size differences or error sizes smaller than 10 m seem to be scientifically inappropriate. Because of larger measuring values and morphologic aberrations associated with vertical discrepancies 2 and 3, larger variability of the statistical measures was expected. Thus, it was reasonable to increase the tolerance limits in comparison to discrepancy 1: 1.0 mm for the arithmetic mean and 0.7 mm as at the most acceptable standard error. The first step of the analysis was a graphical evaluation of possible effects during successive reduction, looking at the variability and consistency of the statistical measures (Fig. 5, A and B). The main part of the analysis classified the differences between the initial mean values and those calculated at the successive reduction levels (percentage of initial number of measurements) as admissible error size, provided they were within the predefined tolerance limits. Differences outside were rejected as inadmissible error (Fig. 6). The lowest attainable reduction level that yielded admissible error sizes indicated the lower bound of clinical relevance. Next, the increase of the standard error values was evaluated. The lowest attainable reduction level yielding standard errors smaller than or equal to the predefined maximum values indicated the lower bound of a consistent estimate for the mean (Fig. 7).
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Fig. 6. Variability of mean of vertical discrepancy 1 due to random data selection. Variability illustrated by differences between means of initial data and those of new data. Data sizes indicated as actual number of measurements per crown (in intervals).

C
Fig. 7. A, Variability of standard error of vertical discrepancy 1 due to random data selection. Data sizes indicated as actual number of measurements per crown. B, Variability of standard error of vertical discrepancy 2 due to random data selection. Data sizes indicated as actual number of measurements per crown. C, Variability of standard error of vertical discrepancy 3 due to random data selection. Data sizes indicated as actual number of measurements per crown.

In addition to this analysis, the effort for the investigations and measurements under the assumed reduction of the data sizes was estimated and implications to the supposed cost/benefit model of marginal gap meaJANUARY 2000

surements (Fig. 1) were made. On the basis of the measuring times in the initial protocol, the actual working times for several main preparatory stages (SEM investigation/photograph documentation, marking the read45

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Table II. Estimated measurement effort in minutes

Time per specimen Measurements per specimen Gap measurement SEM investigation and photo documentation Marking the reference points Data computerization Total measurement time

>200 75-125 50-74 40-49 20-39 10-19

Estimation

90-120 50-75 35-50 25-35 15-25 15

min min min min min min

90 90 90 90 90

90 (80) (70) (60) (45) (30)

min min min min min min

120 70 (50) 50 (35) 35 (25) 25 (15) 15 (5)

min min min min min min

60 45 30 15 10 5

min min min min min min

390 280 (225) 220 (170) 175 (125) 150 (85) 125 (55)

min min min min min min

for randomly selected data.

Table III. Mean level of gap size according to gap definition and cementation condition
Mean level (range) Gap definition (sample size) Uncemented = series I Cemented = series II

Vertical discrepancy 1 (n = 10) Vertical discrepancy 2 (n = 5) Vertical discrepancy 3 (n = 5)

30 m (22-42 m) 67 m (40-90 m) 97 m (80-135 m)

51 m (33-66 m) 105 m (88-122 m) 125 m (110-157 m)

ing points, computerization of data) (Fig. 2) were estimated (Table II).

RESULTS
Table III reports the mean level of gap size due to different gap definitions. Figures 5 through 7 illustrate the statistical analysis results for measurements of uncemented (master die) and cemented (replica dies) conditions. Figure 5, A and B, illustrates variability related to vertical discrepancy 1 for all equally spaced and random subsets of 230 measurements considered. Figure 7, A through C, report standard errors of the analyses for all random subsets of 230 sites. The typical variability pattern of mean values is depicted in Figure 5, A and B. The variability was moderate until a reduction level of 25% or 20% of the initial data sets was reached referring to approximately 40 to 50 measurements per gap (namely, increment of 400 to 500 m). Below this level, the variability could increase to values outside the predefined tolerance limit (0.5 mm). Even at 10 to 30 measurements per gap, the majority of the data did not exceed this limit (Fig. 6). The tolerance limit of 0.5 mm referred to the real error size of about 5 m for the calculation of the measurements mean. Differences between equally spaced and random data were small (Fig. 5, A and B). Average variability and error size due to random data selection was slightly greater. This was observed for almost all data for both uncemented or cemented crowns. An overview of all data sets and subsets (Fig. 7, A) showed consistency of the standard error values for the
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mean vertical discrepancy 1 down to an absolute number of about 40 to 50 measurements per crown. Therefore, 50 measurements were accepted as the lower bound for a minimum number of measurements for generating clinically relevant information and a consistent estimate of the mean vertical discrepancy 1. There were negligible differences between randomly selected or equally spaced distances of about 500 m. The variability of cemented crowns increased at a slightly earlier stage (Fig. 7, A). Variability patterns for the vertical discrepancies 2 and 3 looked similar to those of the vertical discrepancy 1, apart from a level of larger gap values (Table III). Effects caused by different subset selection and cementation were negligible. Only data that contained less than 30 measurements yielded standard error values exceeding the predefined tolerance limit of 0.7 mm (Fig. 7, B and C). But, comparing the standard error curves with that of vertical discrepancy 1 (Fig. 7, A), the empirically found standard error value of 0.5 mm represented a more appropriate limit of consistency than 0.7 mm. Consequently, the minimum number of measurements per crown was in a range of about 50 for vertical discrepancies 2 and 3 as well. The time required for different stages of measurement is listed in Table II. There was no linear relationship between the decrease in measurements per crown and decrease of total time observed. Subsets that cover 25% (about 50 measurements) of the initial data set consumed about half the measuring time for the full set of measurements. The nonlinear relation between time and data size is reflected by the nonlinear scale of the
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Fig. 8. Provisional calibration of hypothesized cost/benefit curve in Fig. 1 with random data of vertical discrepancy 1. Error size of mean has been related to actual number of measurements according to empirical data in Fig. 6. Scale of horizontal axis reflects nonlinear relation between time and data size. Curve may provide hypothesis about optimality of measurements on crown margins.

horizontal axis in Figure 8. The vertical axis is implemented by the data of Figure 6, where the errors of mean are related to actual numbers of measurements. Figure 8 represents the attempt to describe the context of optimality in this study and provides at least a hypothesis about optimality of investigations on crown margins in vitro.

DISCUSSION
The minimum number of measurements at the gap depends on the gap variation and on the intended precision of its determination. This is similar to statistical power analysis predicting sample sizes required for hypothesis testing. What both topics generally have in common is that the larger the sample size (number of measurements) the more confidence one can have in being close to the truth and the more precision can be achieved. Because determination of gap sizes does not deal with hypothesis testing, statistical power analysis is not applicable to predict the appropriate number of measurements. Comparison of the fit resulting from different crown systems14-17,19,23 or between successive manufacturing processes7,14,17,18,20 usually intends to detect small differences of mean values that require a large number of measurements per crown. Our study provided an empirical approach to the problem of sample size. The data suggested the need for 50 measurements per crown but, at least 20 to 25 measurements per crown according to the aimed precision level. Measuring crown margins at 4 to 12 sites per crown margin might be misleading, in particular when the fit of different crown systems or manufacturing stages is compared. This potential lack of relevant and consistent
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information should be compensated by a large number of crowns per sample. However, in many studies those numbers are in a range of 5 to 10 specimens per sample or group.7,8,14-23 In contrast, studies that attempt to measure gaps to assess the clinical acceptability of a certain crown system might deal with smaller sample sizes or data. The discussion regarding the upper bound for the so-called clinically acceptable gap size2,4,15 includes a wide range of values. It starts at the recommended reference of about 50 m4,24,25 and reaches to about 120 m.26 Clinical evidence for an unfailing criterion does not exist. Thus, there is little need to manage differences smaller than 10 to 15 m with respect to the mean gap sizes. Regardless of the number of measurements finally taken, inspection of the entire gap is recommended to get important information about the extent of morphologic aberrations and defects. According to the cited definitions of accuracy and precision,27 the sources of technical error contributed to the extent of inaccuracy, whereas the error due to data reduction contributed mainly to the amount of imprecision. The projection error of up to 15% refers to about 7 m of additional technical error for each measurement.7 Therefore, the overall error associated with gap measurements by SEM could reach an amount of 7projection + 5SEM + 5mean + 3se + 1gauge = 21 m deviating from the true gap size. Furthermore, the potential imprecision (5mean + 3se + 1gauge m) interfered with the interrater reliability of about 3 to 5 m for mean values. However, the results of our study do not allow a clear statement concerning accuracy and precision of SEM measurements. At least, the assumptions seem to be
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reasonable in as far as they confirm each other with respect to vertical discrepancy 1. This reasoning should be subjected to crowns only. Different preparation form and geometry may affect observations on inlay castings or other restoration forms in a different way. For equally spaced versus random data, only subsets smaller than 25% to 20% of the initial data sets (less than 40 to 60 measurements) revealed divergent variability patterns. Becasue error due to random selection was slightly larger, randomly selecting measurement sites represented the worst case. Therefore, implications based on the random data were valid for equally spaced data as well. The same tendency was revealed when comparing cemented versus noncemented crowns. Because of higher measurement values (Table III), the data of cemented crowns showed a slightly larger however negligible error size. The data of the vertical discrepancies 2 and 3 supported these observations. The variability pattern was not influenced by these 2 factors; it seemed to be independent of the gap definition. The standard error was lower than expected. In contrast to the vertical discrepancy 1, there was no previous knowledge about the extent of measurements with the vertical discrepancies 2 and 3. A similar course of all standard error curves (Fig. 7, A through C) was suggested to redefine the tolerance limits in that range of measurement numbers, where the curve turned into exponentially increasing values. With the aim to keep the overall measurement error as small as possible, still lower bounds of the minimum number of measurements were not admitted. Therefore, it was preferable to redefine the tolerance limit for standard error at 0.5 mm referring to 5 m as empirical maximum for admissible standard error values. Measuring only 50 sites per crown required approximately half the initially estimated time. Measuring 50 sites as spaced data would require less time for measuring, for marking reading points, and for data computerization, whereas the effort of SEM investigation and photograph documentation would be unchanged. In addition, if 50 measurements were randomly collected, the effort of SEM investigation could be reduced, and there would be no need for marking any reading points. Therefore, the most beneficial effect to the effort of such investigation would be obtained by measuring the crown margins at about 50 randomly selected sites around the circular gap. The implication of these observations supported the sigmoid shape of the cost/benefit model and provided a provisional scale of the x-axis (methodical effort) by the number of measurements per crown. The y-axis (quality of results) reflected the error size of the arithmetic mean (Figs. 1 and 8) from the data depicted in Figure 6.

conclusions for measurement of gaps at margin were made: 1. Approximately 50 measurements along the margin of a crown yielded clinically relevant information and a consistent estimate for the gap size. The overall impact on the measurement error was typically in a range of 8 m. 2. The lower bound for the minimum number of measurements did not depend on the size of the marginal gap. 3. The lower bound of 50 measurements per crown appeared to be independent of whether the crowns were cemented or not. 4. It was of minor importance whether 50 measurements along the margin were randomly selected or recorded in distances of about 500 m. 5. Fifty randomly selected measurements per crown required only about half the time to measure 200 sites per crown.
We gratefully acknowledge the help of H. Httemann, Institute of Geology and Paleontology, University of Tbingen, by performing the SEM investigations.

REFERENCES
1. Becker CM, Kaldahl WB. Current theories of crown contour, margin placement, and pontic design. J Prosthet Dent 1981;45:268-77. 2. Gardner FM. Margins of complete crownsliterature review. J Prosthet Dent 1982;48:396-400. 3. Lang NP, Kiel RA, Anderhalden K. Clinical and microbiological effects of subgingival restorations with overhanging or clinically perfect margins. J Clin Periodontol 1983;10:563-78. 4. Kerschbaum Th. The reliable crown margin? An analysis under clinical aspects. In: Walther W, Heners M, editors. Quality assurance in dentistrydemand and reality. [in German] 1st ed. Heidelberg: Hthig Verlag; 1995. p. 19-45. 5. Felton DA, Kenoy BE, Bayne SC, Wirthman GP. Effect of in vivo crown margin discrepancies on periodontal health. J Prosthet Dent 1991;65: 357-64. 6. Valderhaug J, Birkeland JM. Periodontal conditions in patients 5 years following insertion of fixed prostheses. Pocket depth and loss of attachment. J Oral Rehabil 1976;3:237-43. 7. Groten M, Girthofer S, Prbster L. Marginal fit consistency of copy-milled all-ceramic crowns during fabrication by light- and scanning-electronmicroscopic analysis in vitro. J Oral Rehabil 1997;24:871-81. 8. Sorensen JA. A standardized method for determination of crown margin fidelity. J Prosthet Dent 1990;64:18-24. 9. Heymann HO, Bayne SC, Sturdevant JR, Wilder AD, Roberson TM. The clinical performance of CAD-CAM-generated ceramic inlays: a four-year study. J Am Dent Assoc 1996;127:1171-81. 10. Roulet J-F. Margin quality: criteria and techniques for assessment. In: Anusavice KJ, editor. Quality evaluation of dental restorations. Criteria for placement and replacement. 1st ed. Chicago: Quintessence Publishing; 1989. p. 223-41. 11. Ryge G. The California Dental Association quality evaluation system. A standard for self-assessment. In: Anusavice KJ, editor. Quality evaluation of dental restorations. Criteria for placement and replacement. 1st ed. Chicago: Quintessence Publishing; 1989. p. 273-90. 12. Schmalz G, Federlin M, Geurtsen W. The scientific view of ceramic inlays and veneers for clinical use. [in German/English summary] Dtsch Zahnrztl Z 1994;49:197-208. 13. Holmes JR, Bayne SC, Holland GA, Sulik WD. Considerations in measurement of marginal fit. J Prosthet Dent 1989;62:405-8. 14. Davis DR. Comparison of fit of two types of all-ceramic crowns. J Prosthet Dent 1988;59:12-6. 15. Holmes JR, Sulik WD, Holland GA, Bayne SC. Marginal fit of castable ceramic crowns. J Prosthet Dent 1992;67:594-9.

CONCLUSIONS
Within the limits of this investigation, the following

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