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Clin Oral Invest (2003) 7:819 DOI 10.

1007/s00784-002-0186-z

O R I G I N A L A RT I C L E

M. Hayashi N.H.F. Wilson C.A. Yeung H.V. Worthington

Systematic review of ceramic inlays

Received: 19 August 2002 / Accepted: 21 October 2002 / Published online: 21 December 2002 Springer-Verlag 2002

Abstract The purpose of the present study was to conduct a systematic review of ceramic inlays, assess the quality of published clinical studies, and determine the clinical effectiveness of ceramic inlays compared to other forms of posterior restorations. Prospective clinical trials of ceramic inlays published from 1990 to 2001 were retrieved by electronic and hand searching. The methodological quality of each study was assessed by two calibrated reviewers using a standardised checklist. The clinical effectiveness of ceramic inlays was evaluated in terms of failure rate, postoperative pain, and aesthetics. The results were compared to those of other forms of posterior restorations by means of an odds ratio. Among 46 articles selected for quality assessment, only five (10.6%) reported randomised controlled trials and 15 (32.6%) presented controlled clinical trials. The remaining 26 papers (56.5%) were longitudinal clinical trials lacking control groups. Only three papers fulfilled the requirement for statistical analysis to evaluate the clinical effectiveness of ceramic inlays. The results indicate no significant differences in longevity or postoperative sensitivity between ceramic and other posterior restorations over assessment periods of up to 1 year. It is concluded that no strong evidence is available to confirm the clinical effectiveness of ceramic inlays in comparison to other posterior restorations. Greater attention is required to the design and reporting of studies to improve the quality of clinical trials of ceramic inlays. Keywords Systematic review Ceramic inlay Clinical effectiveness Longevity Odds ratio
M. Hayashi () Department of Restorative Dentistry and Endodontology, Osaka University Graduate School of Dentistry, 18 Yamadaoka, Suita, 565-0871 Osaka, Japan e-mail: mikarin@dent.osaka-u.ac.jp Tel.: +81-6-6879-2927, Fax: +81-6-6879-2928 N. H. F. Wilson Guys, Kings and St. Thomas Dental Institute, London, UK C. Yeung H. Worthington University Dental Hospital of Manchester, Manchester, UK

Introduction
A variety of materials can be employed for posterior restorations in everyday clinical practice. Clinicians need to take into account increasing patient expectations of aesthetic restorations as well as functional considerations in selecting materials for posterior restorations. Among tooth-coloured restorations, ceramic inlays are considered to offer the best aesthetics, given the possibility of exact colour matching with natural tooth tissues [35, 72]. Ceramic inlays were first introduced in the late 1880s [5]. However, they did not become popular then because of difficulties in construction and a high failure rate [5, 68]. With improvements in the physical properties of ceramics and the introduction of adhesive techniques, ceramic inlays have been used increasingly for posterior restorations since the 1980s [68]. The failure rate of ceramic inlays has recently been reported to be 8.013.3% after 8 to 10 years in clinical service [31, 66, 70]. However, the long-term clinical performance of ceramic inlays in relation to other posterior restorations remains to be fully evaluated. In addition, the clinical procedures and construction techniques for such restorations are complicated and require expensive equipment, making the cost of these inlays relatively high. Despite favourable characteristics, ceramic inlays therefore may not find application in all situations indicating the use of tooth-coloured restoratives. For a comprehensive evaluation of the clinical effectiveness of posterior restorations, various factors such as longevity, postoperative discomfort, cost, treatment time, and aesthetic qualities should be considered according to the requirements of patients. Comparisons of such a variety of characteristics between ceramic inlays and other forms of posterior restorations aid in the decision-making processes. There is an increasing expectation that clinical practice be evidence-based [4, 12]. The best evidence of the clinical effectiveness of alternative interventions is increasingly being sought by patients and clinicians. Health care providers are inundated, however, with un-

manageable amounts of unrelated information, with the selection of relevant information requiring particular skills and knowledge. The best evidence of the clinical effectiveness of alternative interventions has been considered to be in systematic reviews of randomised controlled trials [12]. Systematic reviews of published literature, which use objective and reproducible methods to identify eligible studies and abstract and analyse relevant data, provide the most useful mechanism for assessing the evidence presented by clinical trials. To make systematic reviews reliable and unbiased, they must be carried out rigorously and adhere fully to an exacting methodology [11, 80]. Studies included in the reviews are selected by systematic application of a predetermined list of criteria. Results of the studies selected should be synthesised appropriately by means of powerful statistical methods. By employing explicitly defined methods, systematic reviews are able to integrate existing information effectively and provide comprehensive summaries of all available evidence. The purposes of the present review were to assess the quality of published clinical trials on ceramic inlays and evaluate their clinical effectiveness using a systematic approach. To evaluate clinical effectiveness, the following null hypotheses were tested: (1) there is no difference in longevity between ceramic inlays and other posterior restorations, (2) there is no difference in postoperative discomfort between ceramic inlays and other posterior restorations, (3) there is no difference in the aesthetic qualities of ceramic inlays and other tooth-coloured posterior restorations.

Search strategy
A journal search, consisting of both electronic and hand searching, was undertaken to identify all relevant studies, irrespective of language. Electronic databases Electronic searches included the following databases from 1990 to 2001: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The subject search used a combination of controlled vocabulary and free text based on the search strategy for MEDLINE using the key words ceramics, dental porcelain, and inlays. Hand searching of databases Hand searching of the following key journals from 1990 to 2001 was undertaken: Acta Odontologica Scandinavica, British Dental Journal, International Dental Journal, Journal of the American Dental Association, Journal of Dentistry, Journal of Dental Research, Japanese Journal of Conservative Dentistry, Journal of Prosthetic Dentistry, Operative Dentistry, and Quintessence International. These ten journals containing articles on restorative dentistry were identified according to experts advice. The reference lists of all the relevant studies, existing reviews, and personal reprint collections of authors were screened for additional relevant publications. Selection of relevant publications Each publication was initially assessed for relevance by two of the authors (MH and CAY) using data presented in the abstract. When an abstract was not available or failed to provide sufficient information, a reprint of the full paper was obtained. When papers or abstracts reported different stages of clinical trial, only the longer-term study was included in the review. When both a full paper and an abstract were published based on data from the same clinical trial, only the full paper was included.

Materials and methods


The Cochrane Collaboration guidelines are primarily intended for conducting systematic reviews of the effectiveness of intervention [11]. In the present review, we attempted to adopt those general principles to evaluate the clinical effectiveness of ceramic inlays from published findings of clinical trials. Additionally, the quality of the published papers on ceramic inlays was assessed by a systematic approach.

Selection criteria
Inclusion and exclusion criteria for the selection of papers for review were established prior to the literature search. The inclusion criteria consisted of written clinical studies (randomised controlled trials (RCTs), controlled clinical trials (CCTs), and case series) of class I and class II ceramic inlay restorations in premolar and permanent molar teeth. All types of ceramic inlays fired, milled-CAD/CAM and copy milled, cast, and heatpressed were included. Excluded were studies involving laminate veneers, ceramic onlays, and ceramic crowns. A case report and a laboratory study were also excluded.

Quality assessment
Quality assessment of the selected papers was undertaken by two reviewers working independently, using the modified systematic assessment list consisting of 24 items (Table 1). This list was developed according to publication guidelines [2, 6, 56] and previously published reviews [52, 69]. The calibration of quality assessment was carried out by two reviewers (MH and CAY) using a sample paper prior to the assessment. The systematic assessment criteria were applied to each paper in turn.

10 Table 1 Intra- and inter-rater agreement on 24 items of quality assessment.N/A not calculable Item Theme assessed Kappa values Intra-rater 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Is the hypothesis/aim/objective of the study clearly described? Is the setting of the study or the source of the subjects studied described? Is the distribution of the study population by age or gender described? Are the inclusion criteria stated? Are the exclusion criteria stated? Are the treatments well described? Are the main outcomes to be measured clearly described in the Introduction or Methods section? Is the sample size stated? Was the sample size justified? Was the concurrent control group used? Was random allocation to treatment used? Was the method of random allocation given? Was blind assessment of the outcome carried out? Was there more than one examiner for outcome assessment? Was examiner calibration carried out? Are the statistical methods described? Is the participation/follow-up rate stated? Was the participation/follow-up rate greater than 80%? Are the nonparticipants/subjects lost to follow-up described? Are the main findings of the study clearly described? Are results stated in absolute numbers when feasible (e.g., 10/20, not 50%)? Are confidence intervals given? Are any important adverse events reported? Are any conclusions stated? 1.00 0.82 1.00 1.00 1.00 1.00 1.00 1.00 1.00 0.62 1.00 1.00 0.05 0.78 0.80 1.00 0.41 0.44 0.42 N/A 0.62 1.00 1.00 1.00 Inter-rater 0.60 0.76 0.96 0.87 0.94 N/A 0.40 N/A 1.00 0.82 1.00 1.00 0.23 0.88 0.83 0.77 0.69 0.55 0.66 N/A 0.93 0.90 1.00 0.58

The two assessors initially evaluated all of the articles independently. The level of agreement between assessors was evaluated using kappa statistics with a 95% confidence interval (CI). Disagreements between the assessors were identified and discussed, and a final score was agreed for each paper. To estimate intra-rater reliability, ten full papers were selected at random and assessed by one reviewer twice with a 1-month interval. The criteria were scored as yes or no or, when insufficient information was provided, as unable to determine. The results were expressed as percentages of the total attainable scores for each of the items assessed.

Data extraction and synthesis The following information was extracted from the papers selected for evaluation of the clinical effectiveness of ceramic inlays: date of the study, year of publication, setting and funding source of the trials, sample size, age and gender of the participants, and the types of teeth and cavities restored. Differences among study participants, duration of study, interventions, outcomes, and information on adverse events or effects were also recorded. Data were extracted by two reviewers independently using specially designed data extraction forms. These forms were piloted on several papers and modified as required before use. Data presented in graphs and figures were extracted whenever possible. Such data were only included, however, if both reviewers independently extracted the same result. Any disagreement was discussed and a third reviewer consulted as necessary. The outcomes were evaluated in terms of failure rate, postoperative pain/discomfort, and aesthetic qualities. Restorations were considered to have failed when replacement was indicated or endodontic problems occurred. In addition, restorations evaluated as clinically unacceptable using clinical criteria such as the UHPHS [9] or CDA [74] criteria were also considered failures. Postoperative pain/discomfort was evaluated as the presence or absence of sensitivity to temperature or occlusal loading within 1 month after restoration.

Evaluation of clinical effectiveness


Study selection To evaluate the clinical effectiveness of ceramic inlays, RCTs and CCTs in which other forms of posterior restorations were used as control groups were selected by the two independent reviewers according to the results of quality assessment. The author of each selected study was contacted to provide detailed information on study design or to provide details with respect to missing data. The study design of each of the selected papers was assessed by a statistician involved in the review process. If a trial was excluded from evaluation because of the study design, the reasons for exclusion were described.

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Statistical analysis
The Cochrane Oral Health Group statistical guideline [80] was followed to evaluate the clinical effectiveness of ceramic inlays. Heterogeneity The significance of the discrepancies in the estimates of treatment effects from the different trials was assessed with Cochrans test for heterogeneity [11]. If any significant heterogeneity (P<0.1) was detected, the significance of treatment effects was assessed using a random effects model. Choice of statistics and estimate of overall effect The odds ratio was calculated along with the 95% CI. Outcome was defined according to the proportions of failures, postoperative pain/discomfort, and patients with complete satisfaction. These evaluations were compared at the most common time points in the studies included. Individual comparisons were made between ceramic inlays and each of the other forms of posterior restoration.

Table 2 Distribution of kappa values of intra- and inter-rater agreement Kappa value Strength of agreement Distribution of kappa values Intra-rater agreement (%) <0.01 0.010.20 0.210.40 0.410.60 0.610.80 0.811.00 Poor Slight Fair Moderate Substantial Almost perfect Total
a One item (no. 20. b Three items (nos.

Inter-rater agreement (%) 0 (0.0) 0 (0.0) 2 (9.5) 3 (14.3) 4 (19.0) 12 (57.1) 21 (100.0)b

1 (4.3) 0 (0.0) 0 (0.0) 3 (13.1) 4 (17.4) 15 (65.2) 23 (100.0)a

in Table 1) could not be calculated 6, 8, and 20 in Table 1) could not be calculated

article [26] was excluded from quality assessment, as only one assessor was able to translate the report. A total of 46 studies [7, 8, 10, 14, 15, 17, 20, 22, 24, 25, 31, 33, 34, 37, 38, 39, 41, 46, 47, 48, 51, 53, 55, 58, 60, 61, 63, 64, 65, 66, 67, 70, 71, 73, 78, 81, 83, 85, 88, 89, 92, 93, 95, 96, 97, 99], including 35 full papers and 11 abstracts, were finally subjected to systematic quality assessment. Results of quality assessment Reproducibility and reliability The assessment of intra-rater agreement indicated a mean difference of 6.3% (95% CI 2.2, 10.4). Kappa values ranged from 0.05 to 1.00, with a median of 1.00, where 61% of the assessments were found to be 1.00, indicating perfect agreement (Table 1). Additionally, 83% of the items assessed showed excellent agreement, with high kappa values of >0.61 (Table 2). The mean difference between the two reviewers in the assessment of a paper was 7.9% (95% CI 6.1, 9.7). The kappa values varied from 0.23 to 1.00, with a median of 0.83 (Table 1), while 76% of the items presented good agreement, with a high kappa value of >0.61 (Table 2). Complete agreement between the assessors was found in eight full papers and four other items assessed. Nearly all of the disagreements were attributed to reading errors or differences in interpretation of the published material. All disagreements between the two assessors were subsequently resolved through discussion. Methodological quality The results on the quality assessment of each paper are presented in Table 3. In terms of study design, only five papers (10.9%) [24, 39, 60, 66, 85] were RCTs, 15 (32.6%) [8, 33, 38, 41, 46, 48, 55, 71, 73, 88, 92, 93, 96, 97, 99] were CCTs, and the remaining 26 (56.5%) [7, 10,

Results
Results of the literature search Electronic and hand searching of journals retrieved a total of 72 papers [1, 7, 8, 10, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 33, 34, 36, 37, 38, 39, 40, 41, 42, 46, 47, 48, 49, 50, 51, 53, 54, 55, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 70, 71, 73, 75, 76, 77, 78, 81, 83, 84, 85, 88, 89, 90, 91, 92, 93, 95, 96, 97, 99], consisting of 52 full papers and 20 abstracts, on the clinical performance of ceramic inlays. The electronic search found 40 papers [1, 7, 14, 15, 17, 19, 20, 22, 24, 26, 30, 31, 34, 36, 39, 41, 50, 51, 53, 54, 55, 57, 58, 60, 61, 66, 67, 70, 76, 81, 83, 84, 85, 88, 89, 90, 92, 93, 96, 97], while hand searching yielded an additional 32 [8, 10, 16, 18, 21, 23, 25, 27, 28, 29, 33, 37, 38, 40, 42, 46, 47, 48, 49, 59, 62, 63, 64, 65, 71, 73, 75, 77, 78, 91, 95, 99]. One German [26] and 12 Japanese papers [23, 27, 28, 29, 37, 38, 42, 46, 47, 62, 65, 95] included documentation on clinical performance. No relevant papers in Dutch or any Scandinavian language were traced. Thirty-seven papers [1, 16, 17, 18, 19, 20, 21, 23, 27, 28, 29, 30, 31, 36, 39, 40, 42, 49, 50, 54, 55, 57, 58, 59, 60, 62, 65, 75, 76, 77, 84, 85, 90, 91, 93, 95, 96] were published from 12 clinical trials using the same data spanning different periods or presented in a different style (full papers or abstracts). The 12 papers [17, 20, 31, 39, 55, 58, 60, 65, 85, 93, 95, 96] reporting data of the longest duration and providing the most detailed descriptions were pooled for quality assessment. One German

12 Table 3 Quality assessment of 46 studies on ceramic inlays. RCT randomized controlled trial, CCT controlled clinical trial Study Ref. Author, design no. year RCT 66 60 85 24 39 CCT 93 55 97 92 96 46 41 38 88 48 8 33 99 72 71 Case 70 series 37 31 17 95 53 22 81 14 18 15 89 68 58 34 65 47 83 61 51 7 78 63 10 64 25 Publication style Items assesseda 1 +b + + + + + + + + + + + + Abstract + + + + + Full paper + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + 2 3 4 5 + + + + + + + + + + 6 7 8 9 10 11 12 13 14 15 16 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + 17 18 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + 19 20 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + 21 22 23 24 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +

Pallesen Full 2000 paper Molin 2000 Sjogren 1998 Gladys 1995 Isengerg 1992 Thorodrup 2001 Manhart 2001 van Dijken 1999 Thordrup 1999 van Dijken 1998 Katsube 1997 Isidor 1995 Inaba 1995 Stenberg 1993 Klimm 1999 Bodenheim 1997 Hein 1997 Zuelling 1996 Roulet 1996 Roulet 1995 Reiss 2000 Iida 2000 Hayashi 2000 Frankenberger 2000 Torii 1999 Malament 1999 Fizzi 1999 Shearer 1998 Felden 1998 Friedl 1997 Fradeani 1997 Studer 1996 Qualtrough 1996 Molin 1996 Heymann 1996 Oka 1995 Kawai 1995 Sjoren 1992 Mormann 1992 Krejci 1992 Bessing 1990 Schulte 1998 Neo 1998 Cerutty 1998 Noack 1994 Goetsch 1991 Full paper

+ + + + + + + + + + + + + + +

+ + + + +

+ + + + + + +

+ + + + + + + + + + + + + + + + + + + + + + + +

+ + + + + + + + + + + + + + + + + + + + + + +

+ + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +

+ + + + +

+ + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +

Abstract

a The 24 items assessed refer to Table 1 b Items received yes in quality assessment

13 Table 4 Quality asessment of 46 full papers and abstracts Item Themes assessed Numbers of yes answers in 46 papers (%) 42 (91) 25 (54) 28 (61) 20 (44) 11 (23) 46 (100) 40 (87) 46 (100) 0 (0) 20 (44) 5 (11) 0 (0) 2 (4) 22 (48) 13 (28) 29 (63) 29 (63) 25 (54) 23 (50) 46 (100) 36 (78) 6 (13) 0 (0) 44 (96)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Is the hypothesis/aim/objective of the study clearly described? Is the setting of the study or the source of the subjects described? Is the distribution of the study population by age or gender described? Are the inclusion criteria stated? Are the exclusion criteria stated? Are the treatments well described? Are the main outcomes to be measured clearly described in the introduction or Methods section? Is the sample size stated? Was the sample size justified? Was the concurrent control group used? Was random allocation to treatment used? Was the method of random allocation given? Was blind assessment of the outcome carried out? Was there more than one examiner for outcome assessment? Was examiner calibration carried out? Are the statistical methods described? Is the participation /follow-up rate stated? Was the participation /follow-up rate greater than 80%? Are nonparticipants/subjects lost to follow-up described? Are the main findings of the study clearly described? Are results stated in absolute numbers when feasible (e.g., 10/20, not 50%)? Are confidence intervals given? Are any important adverse events reported? Are any conclusions stated?

14, 15, 17, 20, 22, 25, 31, 34, 37, 47, 51, 53, 58, 61, 63, 64, 65, 67, 70, 78, 81, 83, 89, 95] were longitudinal clinical trials without control groups. Amongst these RCTs and CCTs, two trials [38, 88] had parallel design and six [60, 66, 85, 96, 97, 99] had split-mouth design. The designs for the 12 remaining studies [8, 24, 33, 39, 41, 46, 48, 55, 71, 73, 92, 93] were not explicitly stated, inappropriate, or unable to be determined due to insufficient information. The results on quality assessment for each item are summarised in Table 4. Overall, aim/objectives, treatments, sample size, main findings, and conclusions were described in almost all of the studies. In contrast, none of them mentioned justification of sample size, method of random allocation, or important adverse events. More than half of the studies (54%) described the setting of the study or the source of the subjects. Sixteen studies recruited subjects from dental school patients [14, 17, 24, 31, 37, 38, 46, 47, 60, 64, 65, 67, 78, 89, 95, 97]. Five involved patients who attended private practice [15, 22, 33, 41, 53], while another four [58, 83, 85, 96] recruited participants from dental school patients, private practices, and community health centers. Less than half of the studies (44%) provided inclusion criteria for the recruitment of participants. Exclusion criteria were stated in only 23%. The extent of the details on the inclusion and exclusion criteria varied from study to study. For inclusion, primary caries, replacement of restorations, Class II restoration, good oral hygiene, sound periodontal condition, and aesthetic demands were

considered. For the exclusion criteria, poor oral hygiene, active periodontitis, high levels of caries progression, bruxism or clenching, malocclusion, and occlusal parafunction were considered. None of the RCTs stated methods of randomisation such as the generation and concealment of random allocation. Furthermore, although almost half of the studies (48%) employed more than one examiner in clinical evaluation, calibration of the examiners was carried out in only 28% of the trials, and blind assessment was undertaken in only 4%. The recall rates of participants were recorded in 29 papers (63%). A total of 13 investigations (28%) [10, 15, 20, 24, 46, 60, 61, 64, 66, 67, 85, 88, 92] achieved 100% recall rates over periods of 1.5 to 8 years. Only five papers [65, 89, 96, 97, 99] (11%) reported the numbers and reasons for patients lost from the trials. Most studies (87%) defined the main outcome in their Introduction or Materials and methods sections, prior to the trial description. However, none of the studies estimated the sample size expected to detect possible significant differences for the anticipated outcomes. To evaluate the clinical performance of ceramic inlays, 30 studies (65%) [8, 10, 14, 15, 17, 20, 22, 25, 31, 34, 37, 38, 39, 46, 47, 48, 51, 55, 61, 63, 64, 65, 66, 70, 71, 88, 89, 95, 96, 97] used the USPHS criteria, and seven (15%) [7, 58, 60, 83 85, 92, 93] followed the CDA criteria. Other than patient dropout, none of the papers addressed the subject of deviation from the protocol. In 78% of the studies, the main findings were described in absolute numbers rather than as percentages.

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While 63% used statistical treatments, only 13% expressed their results in statistical analysis with confidence intervals. Randomised controlled trials The literature search yielded five randomised controlled trials presented as full papers [24, 39, 60, 66, 85]. Two studies [24, 60] used different types of posterior restorations such as gold inlays and composite resin inlays as control groups. Another two [39, 66] compared ceramic inlays made from different ceramic blocks, and the remainder [85] compared ceramic inlays placed with different types of cement. In the four RCTs [24, 60, 66, 85], trial outcomes were evaluated by more than one examiner and 100% recall was achieved. Controlled clinical trials The literature search yielded 15 controlled clinical trials consisting of nine full papers and six abstracts with a variety of types of control. Six studies [33, 38, 48, 55, 88, 93] used control groups of different types of posterior restorations: composite resin inlays in two [55, 93], gold inlays in one [38], amalgams in one [88], both composite resin inlays and direct composites in one [48], and composite resin inlays, direct composites, and amalgam in the remainder [33]. The clinical performance was compared between different types of ceramic inlay systems in one study [92], between different ceramic materials in one [46], and between different luting cements in seven [8, 41, 71, 73, 96, 97, 99]. All of the nine studies published in full papers achieved recall rates of >80%.

Study selection for evaluation of clinical effectiveness To evaluate the clinical effectiveness of ceramic inlays, studies in which other posterior restorations were used as control groups were identified. A total of eight papers [24, 33, 38, 48, 55, 60, 88, 93] , consisting of two RCTs [24, 60] and six CCTs [33, 38, 48, 55, 88, 93], were identified. The designs of these studies are summarised in Table 5 and Table 6. As a consequence of study design assessment, three [38, 60, 88] of the eight papers were included in the evaluation of clinical effectiveness, while the remaining five [24, 33, 48, 55, 93] were excluded. The reasons for exclusion are described in Table 6. One RCT [24] did not clearly describe the study design (parallel or splitmouth design), and the numbers and types of restorations per patient could not be determined. Two abstracts [33, 48] did not state the numbers of restorations at baseline, making it impossible to determine recall rates. Although the authors of these studies were contacted for more detailed information on study design, none replied. These three studies were therefore excluded from the statistical treatment. In one CCT [55], the restorations were allocated according to cavity size. When the width of a restored cavity was more than two thirds the occlusal width, it was restored with ceramic inlays. When the width was less than two thirds, a composite was used. As this allocation sequence was considered to affect the prognosis of restorations [98], the data from this paper were not used. One other CCT [93] described using a split-mouth design. However, half of the patients received only one restoration. Furthermore, the numbers of failed patients for each type of restoration could not be determined. This study was therefore also excluded. As a result of the assessment of the selected papers, one RCT [60] and two CCTs [38, 88] remained for the

Table 5 Studies included in the evaluation of clinical effectiveness of ceramic inlays. RCT randomized controlled trial, CCT controlled clinical trial Author Molin 2000 [60] Method RCT, split-mouth design, four test groups, 5-year duration Participants A total of 80 teeth restored (20 resotrations for each treatment group), all restorations followed-up, nine males and 11females 2356 years of age 24 out of 26 ceramic inlays and 18 of 19 amalgam completing 25 ceramic inlays in 20 individuals and 25 amalgam fillings in 19 individuals completing, all restorations followed, 1519 years of age Interventions Treatment groups: CAD/CAM (Cerec), sintered (Mirage), or heat-pressed (Empress) ceramic inlays control group: gold inlay Treatment group: sintered ceramic inlay (Clapearl/Optec) control group: gold inlay Outcomes Longevity (failure) CDA clinical criteria Note Universitybased

Inaba 1995 [38]

CCT, parallel design, two test groups, 1-year duration CCT, parallel design, two test groups, 2-year duration

USPHS clinical criteria

Universitybased

Stenberg 1993 [88]

Treatment group: Castable USPHS clinical ceramic inlay (Dicor) criteria control group: amalgam

15 Table 6 Studies excluded from the evaluation of clinical effectiveness of ceramic inlays. RCT randomized controlled trial, CCT controlled clinical trial Author, year, ref., duration Thordrop 2001 [93] 5 years Method CCT Interventions Treatment group: ceramic inlay control group: composite resin inlay Treatment group: ceramic inlay control group: composite resin inlay Reasons for exclusion Sort of split-mouth design, however, some patients only received one treatment. We were unable to use the data

Manhart 2001 [55] 2 years

CCT

Allocation sequence is considered to lead to bias. The restorations were allocated to teeth treated according to cavity size. When the width of the cavity restored was more than 2 of the occlusal width, 3 the the cavity was restored with ceramic inlays; when less than 2, 3 composite was used

Klimm 1999 [48] 2 years

CCT

Treatment group: Numbers of restorations at baseline were unclear, therefore we ceramic inlay were unable to calculate the recall rate control groups: composite resin inlay, composite resin Treatment group: ceramic inlay control groups: composite resin inlay, composite resin, amalgam Treatment group: ceramic inlay control group: composite resin inlay Numbers of restorations at baseline were unclear, therefore we were unable to calculate the recall rate

Hein 1997 [33]

CCT

Gladys 1995 [24] 3 years

RCT

Study design (parallel or split-mouth) was not clear. We were unable to clarify numbers and types of restorations placed per patient

evaluation of clinical effectiveness. Two [38, 60] of them were comparisons between ceramic inlays and metal inlays, and the other [88] used amalgam as a control group. Since they all used metallic materials as a control restorative, the aesthetic qualities of ceramic inlays could not be considered in the present review. Analyses of longevity The selected RCT compared the failure rates between 60 ceramic and 20 metallic inlays over 5 years [60]. Three ceramic inlays and one gold inlay had failed at 1-year review, one more ceramic inlay had failed at 3-year review, and three more ceramic and one more gold inlay had failed at 5-year review. Each failure was found in a different patient, except one in whom two ceramic inlays failed. In the present review, the three types of ceramic inlay were combined to form a ceramic group. A conditional logistic regression model was applied taking the clustering of restorations within a patient into account. As there was no patient with failures of both gold and ceramic restorations, in order to fit the model, an extra patient was added with one failure for gold and one for ceramic. There was no significant difference in failure rates between ceramic and gold inlays, with an odds ratio of 1.12 (SE 1.48; 95% CI 0.08, 15.0; P=0.98). In one of the selected CCTs, 26 ceramic and 19 metallic inlays were placed at baseline and 24 ceramic and 18 metallic restorations were reviewed [38]. No failures

were reported 1 year later, and there was no significant difference in failure rates between the ceramic and metallic inlays. The other CCT [88] compared the numbers of failures between 25 ceramic inlays and 25 amalgams in 20 and 19 individuals, respectively. All of the restorations were followed for 2 years. One ceramic inlay failed at 1 year and a second at 2 years due to fracture, while two amalgams in the same patient needed repair due to caries at the 2-year review. Statistical treatment could not be carried out due to small sample sizes. However, no significant difference was found between the failure rates of ceramic inlays and amalgam. As all three studies showed no significant differences in failure rates between ceramic inlays and other restorations, the data were unable to be synthesised by metaanalysis. Analyses of postoperative sensitivity In the selected RCT [60], no ceramic inlays were associated with postoperative sensitivity, while one gold inlay was found to give rise to symptoms 1 week after placement. In one CCT [38], postoperative sensitivity was found in 11 of the 26 ceramic inlays and nine of the 19 metallic inlays 2 weeks after placement. In this study, no significant difference was detected in the incidence of postoperative sensitivity between ceramic and metallic inlays, with an odds ratio of 0.81 (95% CI 0.25, 2.68; P=0.70).

16

The other CCT comparing ceramic inlays and amalgam found no restoration with postoperative sensitivity in either group [88]. There was no significant difference in the incidence of postoperative sensitivity between ceramic inlays and amalgams As all three studies showed no significant difference in postoperative sensitivity between ceramic inlays and other restorations, the data were unable to be synthesised by meta-analysis.

Importance of randomised controlled trials Well-designed, properly executed RCTs have been known to provide strong evidence of the effectiveness of health care interventions [3, 45, 56, 86]. However, only 5% of the 46 clinical trials retrieved in the present review were RCTs. Further clinical research on ceramic inlays should satisfy the essential requirements of meaningful RCTs. In theory, bias should be minimised if randomisation is strictly and appropriately applied [13]. Successful randomisation is an essential requirement for maintaining the quality of clinical trials. Such randomisation depends on two interrelated aspects: the generation of an unpredictable allocation sequence and the concealment of this sequence from investigators enrolling participants [56]. Recent studies indicate that trials in which the allocation sequence had been inadequately concealed yielded larger estimates of treatment effects than trials reporting adequate allocation concealment [44, 79]. Careful attention to randomisation is therefore required when conducting and reporting clinical trials. Despite the importance of the random allocation sequence, none of the RCTs published on ceramic inlays described the methods of randomisation. Researchers conducting clinical trials should be fully aware of the importance of a rigorous randomisation sequence and its application. Recall rate The occurrence of dropped participants is unavoidable in clinical trials involving representative samples of patients, as is the associated uncertainty as to the fate of their restorations. In the present review, 54% of the 46 papers retrieved presented recall rates of over 80% over periods of 1 to 8 years. Among these, 28% achieved 100% recall rates over 1.5 to 8 years. Careful consideration of dropped restorations is required when considering outcome, given that actual failure rates can only be determined if a 100% recall is achieved. In the present review, 46% of the papers included reported <80% recall rates over periods of 0.5 to 14 years. In 37% of the papers, it was impossible to calculate recall rates, since the numbers of participants at the time of recruitment and/or review were not stated. It is strongly recommended that flow charts be used to present the numbers of participants in every step of analysis in order to depict their passage through a trial [56]. For a systematic approach, including studies with recall rates as low as 80% means the introduction of bias (attrition bias), particularly as the number of inclusions increases. Excluding patients from analysis can lead to exaggerated outcomes or erroneous conclusions [32]. Therefore, studies with low recall rates should be excluded from data synthesis of the type reported.

Discussion
Literature search Hand searching of the relevant literature is recommended along with electronic searching, since the overlap in journals covered by MEDLINE and EMBASE has been estimated at approximately 34% [87]. In the present review, electronic search retrieved 56% of the articles, with the remaining 44% being found by hand. It is generally recognised that bias towards positive and encouraging results (publication bias) is a limitation in literature searches. This is attributed to the fact that uninteresting information is less likely to reach the publication stage, which may lead to erroneous conclusions on therapeutic effectiveness [82]. Tracing unpublished trials is therefore recommended in order to eliminate this type of bias [11]. In addition, written communication to the authors was recognised as effective for providing or clarifying important or unstated information. Although attempts were made to trace non-English publications, the search for articles not in English or Japanese was difficult due to the lack of sufficient access to databases and translators. A number of articles are likely to have been published in German, Scandinavian, French, and Italian, considering the popularity of ceramic inlays in the respective countries [35, 70]. The accessibility to databases and translators over a wide range of languages was a limitation of the review. Methods of quality assessment For quality assessment of the published articles, 24 items were identified with reference to the unified statement of a panel of experts (the CONSORT statement) published in 2001 [56]. This consists of 23 essential items found to facilitate the critical appraisal and interpretation of RCTs, providing guidance to authors so as to improve their reporting of trials. The results of intra- and inter-rater agreement indicate good agreement in almost 80% of the items assessed. This showed that the quality assessment methods used in the present review were reproducible and reliable. Summary scores were not calculated for each article, as these had caused problems in identifying trials of high quality [43]. In the present review, therefore, quality score was not assessed item by item but across each paper as a whole.

17

Double-blind assessment In clinical trials, the term blinding refers to keeping study participants, clinicians, and sometimes those collecting and analysing the clinical data unaware of the assigned intervention. The blinding of patients, clinicians and other persons involved in evaluating outcomes also minimises the risk of detection bias. This type of bias arises if the knowledge of a patients assignment influences the process of outcome assessment. Blinding of data analysts can also prevent bias, as knowledge of the interventions received may influence the choice of analytical strategies and methods used. There is a difficulty in conducting double-blind assessment in dental interventions as found in the present review. Double-blind assessment is, for example, impossible in the evaluation of ceramic and gold inlays, given that the materials can be readily distinguished. Only in comparisons between tooth-coloured restorations is the blinding to assessors and patients possible, but in most cases, the restorative materials can be distinguished. Reflecting this characteristic, quality scores with blind assessment ought to be low. This should be taken into account when evaluating the quality of papers and utilising the results of quality assessment for further analyses. Justification of sample size Though all of the studies retrieved stated the sample sizes of the trials, none of them justified the sample size, let alone calculated the number of participants required prior to commencing the trial. For scientific and ethical reasons, sample size needs to be planned prior to recruiting participants, balancing clinical and statistical considerations. Ideally, a study should be sufficiently large to have a high probability of detecting statistical significance between the materials to be compared. It should be noted that reports of studies with small sample sizes frequently include the erroneous conclusion that the intervention groups do not differ, although too few patients were studied to make such a claim [4]. This important issue should be addressed, since few authors in clinical investigations reported the sample size [3, 94], as found in the present review. Clinical effectiveness of ceramic inlays Since the best evidence of the clinical effectiveness of interventions is considered to be provided by systematic reviews of randomised controlled trials, an attempt was made to adopt a systematic approach to investigating the clinical effectiveness of ceramic inlays. The assessment of relevant studies in terms of study design yielded, however, only three clinical trials of appropriate quality. The clinical effectiveness of ceramic inlays can not be determined from such a limited number of single-centre trials, all of which included relatively small numbers of

participants (in the range of 20 to 25) with relatively short-term follow-up assessments over periods of one to 5 years. A comprehensive approach to evaluating the clinical effectiveness of ceramic inlays had been planned to include longevity, postoperative pain, aesthetic qualities, and cost effectiveness. This evaluation could not be carried out due to the lack of sufficient information. A variety of statistical approaches were planned, such as metaanalysis, subgroup analysis, sensitivity analysis, and assessment of publication bias. We were unable to carry out such analyses in the present review due to the small number of well-designed clinical trials reported. Such a statistical approach, if possible, could have clarified the clinical effectiveness and longevity of ceramic inlays. Well-designed clinical trials of ceramic inlays, following the CONSORT requirements [56], would be of value and facilitate future systematic reviews of such restorations. Such work, however, would not address questions on the efficacy of ceramic inlays in everyday clinical practice. To find such answers, large practicebased studies with sophisticated design would be required to include consideration of cost benefits and consequences in terms of preserving teeth for life.

Conclusion
Based on the results of the literature search, critical appraisal, and the statistical analysis of clinical data, it is concluded that no significant differences existed in longevity or postoperative sensitivity between ceramic and other posterior restorations over assessment periods of up to 1 year. Greater attention to the design and reporting of studies is required to improve the quality of clinical trials of ceramic inlays. The best evidence is obtained from well-designed randomised controlled trials with sufficient numbers of participants and restorations assessed over extended periods of time.
Acknowledgements The authors would like to thank Mrs. Sylvia Bickley and Ms. Anne-Marie Glenny at the Cochrane Oral Health Group for their help with the literature search and developing the quality assessment criteria. This study was supported in part by a Grant-in-Aid for Scientific Research (no. 14571812) from the Japan Society for the Promotion of Science.

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