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Resin-modified glass-ionomer cements versus
resin-based materials as fissure sealants: a meta-analysis of clinical
trials.
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| Abstract: |
AIM: To appraise quantitatively current evidence regarding the
caries-preventing effect of resin-modified glass-ionomer cement (RM-GIC)
fissure sealants in comparison to that of resin-based fissure sealants.
STIIDY DESIGN: Systematic review with meta-analysis. METHODS: 8
Anglophone databases and 2 Lusophone databases were searched until 15
April 2009, using a pre-determined search strategy. Clinical trials were
considered for inclusion if their titles/abstracts were relevant to the
topic, published in English, Portuguese or Spanish and had a two-arm
longitudinal study design. The outcome measure of the caries-preventive
effect was caries absence on sealed teeth. Two reviewers independently
extracted data from the accepted articles in order to complete a 2 x 2
table for meta-analysis. The unit of interest was the tooth, and the
number of caries-free teeth (n) at the end of each time interval (6, 12
and 24 months) was compared against the total number of evaluated teeth
(N) STATISTICS: Datasets were assessed for their clinical and
methodological heterogeneity, following Cochrane guidelines, and only
homogeneous datasets were combined for meta-analysis, using a random
effects model (RevMan 4.2). Differences in the caries-preventive effect
were computed on the basis of the combined Relative Risk (RR) with 95%
confidence interval (CI). RESULTS: Of the 212 articles identified, only
6 trials were included. From these, 19 separate datasets were extracted.
For the pooled data, equivalent caries-preventive effects were observed
at 6 months (RR = 0.98, 95% CI 0.95-1.00; p = 0.08); 12 months (RR =
1.00, 95% CI 0.96-1.04, p = 0.99) and 24 months (RR = 1.01, 95% CI
0.84-1.21, p = 0.91). The 36-month data (not pooled) favoured
resin-based sealants (RR 0.93, 95% CI 0.88-0.97, p = 0.002) CONLUSIONS:
This meta-analysis found no conclusive evidence that either material was
superior to the other in preventing dental caries. Key words: Resin-modified glass ionomers; resin; fissure sealant; meta-analysis |
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| Article Type: | Report |
| Subject: |
Dental caries
(Care and treatment) Dental caries (Research) Pit and fissure sealants (Dentistry) (Health aspects) Pit and fissure sealants (Dentistry) (Research) |
| Authors: |
Yengopal, V. Mickenautsch, S. |
| Pub Date: | 02/01/2010 |
| Publication: | Name: European Archives of Paediatric Dentistry Publisher: European Academy of Paediatric Dentistry Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2010 European Academy of Paediatric Dentistry ISSN: 1818-6300 |
| Issue: | Date: Feb, 2010 Source Volume: 11 Source Issue: 1 |
| Topic: | Event Code: 310 Science & research |
| Geographic: | Geographic Scope: South Africa Geographic Code: 6SOUT South Africa |
| Accession Number: | 277106713 |
| Full Text: |
Introduction Use of pit and fissure sealants (FS) has become accepted as an effective intervention for the prevention of occlusal caries in the molar teeth of young children [Kitchens, 2005; Ahovuo-Saloranta et al., 2008]. The evidence for the clinical efficacy and cost-effectiveness of FS in reducing occlusal caries in molars has been highlighted in recent papers [Kitchens, 2005; Ahovuo-Saloranta et al., 2008]. Resin-based FS materials are most commonly used and are regarded as the 'gold standard' for sealing pits and fissures [Adair, 2003]. Their caries- preventive effect relies on the sealing of pits and fissures through micro-retention, created through tags after acid etching of enamel. However, these are easily destroyed by saliva contamination, reducing micro-retention and consequently, the caries-preventive effect [Bishara et al., 2002]. Moreover, the preventive benefits and resin-based FS retention are gained and maintained only as long as the sealants remain completely intact and bonded in place [Oliveira et al., 2008]. Under clinical conditions, it is difficult to maintain an absolutely dry environment in the oral cavity in which to place resin-based FS especially in uncooperative children and in settings where isolation is rarely possible and where equipment such as rubber dam and dental suction is not readily available. Under the generally wet conditions in the oral cavity, glass-ionomer cement (GIC) FS offer an effective alternative to resin sealants, mainly because they have hydrophilic properties [Smith, 1998]. The original glass-ionomer cements, set through an acid-base reaction, between the fluoroaluminosilicate glass powder and the polyalkenoic acid liquid, are generally regarded as 'conventional' glass-ionomers (C-GIC). However, C-GICs are sensitive to water uptake and loss in the first hours or days after setting, and this led to the development of 'resin-modified' GICs (RM-GIC) which, in the set material, contain approximately 10% of resin, usually hydroxyethylmethacrylate (HEMA) [Ikeda et al., 1999]. It has been suggested that the 'gold standard' in caries prevention through FS administration should be based on biological outcomes rather than physical (material retention on the tooth surface) ones [Smith, 1998]. Such biological outcomes are measured in relation to the absence of caries in pits and fissures after FS application. A recent meta-analysis [Yengopal et al., 2009] that assessed biological outcomes found evidence that neither (low-viscosity) C-GIC nor resin-based FS was superior to the other in the prevention of dental caries. To date, no systematic review of the topic of caries-preventive effects of RM-GIC versus resin-based FS has been attempted. Thus, the aim of this systematic review with meta-analysis was to appraise quantitatively the current evidence regarding the caries-preventing effect of RM-GIC fissure sealants in comparison to that of resin-based fissure sealants. Search strategy. The literature search covered 8 Anglophone databases: Biomed Central, Cochrane Oral Health Reviews, Cochrane Library, Directory Of Open Access Journals, Expanded Academic ASAP PLUS, Meta Register Of Controlled Trials--mRCT, PubMed, Science-Direct, and 2 Lusophone databases: Bibliografia Brasileira Em Odontologia - BBO, Literatura Latino-Americana E Caribenha Em Ciencias Da Saude--LILACS. In order to search databases, strings of search terms were constructed, consisting of relevant text words and Boolean links and MeSH words. The string of English search terms: 'Pit and Fissure Sealants'[Mesh] and 'Glass Ionomer Cements'[Mesh] and 'resin modified glass ionomer' and 'fissure sealant*' was used to search the Anglophone databases and the string of Portuguese search terms: 'selante' [palavras] and 'cimentos de ionomeros de vidro' [palavras] and 'CARIE' [Palavras]' was used to search the Lusophone databases. Related words in Spanish were used for LILACS. All publications listed in the databases until 15 April 2009 were included in the search. Inclusion and exclusion criteria. Articles reporting on clinical trials were selected for review from the search results on the basis of their compliance with the inclusion criteria: * Titles/abstracts relevant to topic; * Published in English, Portuguese or Spanish; * Two-arm longitudinal study design. Where only a relevant title without a listed abstract was available, a full copy of the article was assessed for inclusion. A reference check of the included articles was conducted in order to identify further trials suitable for inclusion. Only articles that complied with the inclusion criteria were reviewed further. Full copies of articles were reviewed independently by two reviewers (VY, SM), using the exclusion criteria [Sutherland, 2001]: * No random or quasi-random allocation of study subjects; * Not all entered subjects accounted for at the end of the trial; * Subjects of both groups not followed up the same way; * No computable data reported for both control (comparison) and test groups; * No in-vivo study design. Where several articles had reported on the same trial over similar time periods, the article covering the trial most comprehensively in accordance with the exclusion criteria was accepted. Disagreements between reviewers were resolved by discussion and consensus. Quality Assessment. The quality assessment of the included trials was undertaken independently by two reviewers (VY, SM) and followed established guidelines [Juni et al., 2001; The Grade working group, 2004]. Trials not included in this review were used in piloting the quality assessment process. Disagreements between the reviewers regarding quality assessment ratings scored were resolved through discussion and consensus. Four main quality criteria were examined: (1) Generation of randomisation sequence (Allocation), recorded as: (A) Adequate--e.g. computer generated random numbers, table of random numbers; (B) Unclear; (C) Inadequate--e.g. case record number, date of birth, date of administration, alternation; (2) Allocation concealment, recorded as: (A) Adequate--e.g. central randomisation, sequentially numbered sealed opaque envelopes; (B) Unclear; (C) Inadequate--e.g. open allocation schedule, unsealed or non-opaque envelopes; (3) Blind outcome assessment, recorded as: (A) Yes; (B) Unclear; (C) No; (D) Not used/possible; (4) Completeness of follow-up (clear explanation for withdrawals and loss-to-follow-up in each treatment group), assessed as: (A) Yes, drop outs less than 30%; (B) Yes, drop outs more than 30% ; (C) No explanation. Data extraction from accepted trials. The outcome measure of the caries-preventive effect was the caries absence on sealed teeth. The two reviewers independently extracted data from the accepted articles, using a pilot-tested data-extraction form. Data were extracted in the form of datasets with common characteristics (Table 2). Each dataset included the number of caries-free teeth (n) and total number of evaluated teeth (N) for both the control (comparison) and the test group. Where possible, missing data were calculated from information given in the tables and texts of the articles, in order to complete a 2x2 table for meta analysis. Disagreements between reviewers during data extraction were resolved through discussion and consensus. It was anticipated that some of the studies eligible for inclusion would be split-mouth in design. The split-mouth study design is commonly used in dentistry to test interventions and has the advantage of having an individual serve as both experiment and control. In this study design, one or more pairs of teeth (e.g. primary molars) form the unit of randomisation. Strictly speaking, these pairs are not independent and should be analysed as 'paired data' on a patient basis. However, as in other systematic reviews where split-mouth trials are included [Ahovuo-Saloranta et al., 2008], the decision was to analyse the pairs independently in order to avoid the exclusion of trials that were directly related to the research question. Meta-analysis. Datasets were assessed for their clinical and methodological heterogeneity, following Cochrane guidelines [The Cochrane Collaboration, 2006]. Datasets were considered homogenous if they did not differ substantially in the following clinical and methodological aspects: age of patients; follow-up period; type of FS material used; frequency of FS material application; measured outcome. The percentage of total variations across datasets ([I.sup.2]) and the associated p-value (<0.10) were used in assessing statistical heterogeneity [Thompson, 1994]. Only identified homogeneous datasets from included trials (clinical and methodological homogeneity) were combined for meta-analysis, for which the random effects model of the meta-analysis software, RevMan 4.2 was used. The differences in the caries-preventive effect were computed on basis of the combined Relative Risk (RR) with 95% confidence interval (CI). Datasets were assigned a Mantel-Haenszel weight in direct proportion to sample size. For datasets that were not suitable for meta-analysis, due to aspects related to clinical and methodological heterogeneity, RR scores with 95% CI were calculated for each dataset and reported separately. Results An initial search in PubMed resulted in 212 articles, of which 8 trials [Raadal et al., 1996; Kilpatrick et al., 1996; Winkler et al., 1996; Tantbirojn et al., 1997; Smales and Wong, 1999; Pardi et al., 2005; Kantovitz et al., 2006; Oliveira et al., 2008] complied with the inclusion criteria. A reference check and a subsequent search of the other 7 Anglophone databases and the 2 Lusophone databases generated no further results. Two the 8 articles [Tantbirojn et al., 1997; Kantovitz et al., 2006] were excluded because they reported on in-vitro trials. Hence only 6 articles [Raadal et al., 1996; Kilpatrick et al., 1996; Winkler et al., 1996; Smales and Wong, 1999; Pardi et al., 2005; Oliveira et al., 2008] were accepted for quality assessment and further data extraction. Quality assessment and Data extraction of accepted articles. Table 1 presents data on the quality assessment of the included trials. All trials scored 'B' (unclear) for Randomized sequence allocation, and Allocation concealment, owing to lack of clear information in the text, 'D' (not possible for Blinding), and 'A' (adequate) for completeness of follow-up. From the 6 accepted articles, 19 separate computable dichotomous datasets with relevance to the review question were extracted. The main clinical and methodological characteristics of the extracted datasets are described in Table 2. The reason for separating the data in this format was the need for avoidance of clinical and/or methodological heterogeneity. Additionally, this allowed for the identification of homogenous datasets, which then could be pooled together for meta-analysis. Considerable variation existed among the datasets in terms of most of the items reported in Table 2. This had an impact upon determining whether the compiled datasets could be pooled for the meta-analyses reported in Figures 1-3. The dataset # 17, extracted from the trial by Kilpatrick et al. [1996], could not be pooled with any of the other datasets because FS were placed on permanent premolar teeth, as opposed to permanent molar teeth in all of the other datasets. In addition, the reporting times, patient characteristics, methods of application and other variables also differed and these factors were considered during compilation of the 19 datasets extracted from the 6 accepted trials (Table 2). Pooling of data for meta-analyses. Only datasets that were considered clinically and methodologically homogenous were pooled for meta-analysis. The unit of interest was the tooth and the number of caries-free teeth (n) at the end of each time interval (6, 12 and 24 months) was compared against the total number of evaluated teeth (N). Datasets from three trials [Raadal et al., 1996; Winkler et al., 1996; Oliveira et al., 2008] were pooled for the 6-month evaluation (Figure 1). The pooled data covered 491 teeth (227 resin-modified glass-ionomer FS and 264 resin FS). The pooled relative risk (0.98, 95% CI 0.95-1.00; p = 0.08) suggests that both materials had an equivalent caries-preventive effect at 6 months post-placement. Datasets from 4 trials [Raadal et al., 1996; Winkler et al., 1996; Pardi et al., 2005; Oliveira et al., 2008] were pooled for the 12-month evaluation (Figure 2). The pooled data covered 719 teeth (341 resin-modified glass-ionomer FS and 378 resin FS) and the pooled relative risk (1.00, 95% CI 0.96-1.04, p = 0.99) also implied equivalent caries-preventive effects at 12 months post placement. Similar results were obtained for the 24-month evaluation (Figure 3, RR 1.01, 95% CI 0.84-1.21, p = 0.91). Only one dataset (#16) was available for comparison at 36 months [Raadal et al., 1996]: thus no meta-analysis was attempted. The results (RR 0.93, 95% CI 0.88-0.97, p = 0.002) indicate that teeth sealed with resin-based FS have a 7% higher chance than those sealed with RM-GIC sealants, of remaining caries-free after 36 months. A further 7 datasets could also not be included in the meta-analyses, due to aspects related to clinical and methodological heterogeneity (Table 3). Of these, none showed any difference in caries absence between teeth sealed with RM-GIC or resin-based materials after 1-, 6-, 12-, 24- or 27 months. Discussion This systematic review with meta-analyses sought to quantitatively appraise the current evidence regarding the caries-preventing effect of RM-GIC FS in comparison to that of resin-based FS over varying time intervals. Of the more than 200 articles identified through the search strategy for this review, only 6 were included. The quality assessment of these trials (Table 1) warrants that the data be treated with caution, owing to an increased risk of bias. All of the included papers scored 'B' (unclear) for an important quality item dealing with two key aspects of selection bias: randomised sequence allocation and allocation concealment. Such bias or systematic error may affect studies by causing either an over- or an under-estimation of the treatment effect of an investigated clinical procedure. Overestimation of such effect has been observed to be the most common [Chalmers et al., 1977]. Schulz et al., [1995] reported a 41% treatment effect overestimation due to selection bias, caused by lack of allocation concealment during the randomisation process alone. As all trials accepted in this review did not include or report on allocation concealment, their results need to be interpreted with caution. Thus, for systematic reviews, readers should note that while in terms of the hierarchy of evidence [Sprague et al., 2008] this form of study design is rated the highest, the level of evidence contained in such a review is only as high as that of the studies that it covers. Meta-analysis of homogeneous datasets at three time intervals (Figures 1-3) showed no statistical differences between RM-GIC and resin-based FS, in caries absence. The results of 7 further heterogeneous datasets (#01, 03, 05, 07, 11, 12, and 17) are in line with the meta-analysis findings (Table 3). At 36 months (dataset #16), the resin-based FS performed, by a margin of 7%, significantly better (RR 0.93, 95% CI 0.88-0.97, p = 0.002) than RM-GIC. However, caution is warranted as the data were drawn from a study with a high risk of bias [Raadal et al., 1996]. Previous publications [Forss and Halme, 1998; Mejare et al., 2003; Ahovuo-Saloranta et al., 2008] have highlighted a number of factors that could potentially affect the caries-preventive effect of FS. Only some of the trials reported on these factors. They include: (a) baseline caries prevalence in the study population (none of the included trials reported on this); (b) number of applications of FS material--single or repeated (all trials reported single application); (c) type of FS material (all included trials); (d) follow-up period (all included trials); (e) type of tooth and location in jaw (reported only by Raadal et al., 1996); (f) fluoride content of drinking water (none); (g) operator factors (one trial [Oliveira et al., 2008]); (h) role of other simultaneous preventive measures, e.g., topical fluoride application (none); and (i) frequency of eating sugary snacks (none). The appropriateness of some of the outcomes reported, especially in the RM-GIC trials, should be noted, as these FS are effective long after being regarded as 'lost' or 'partially lost' [Songpaisan et al., 1995, Williams et al., 1996]. It has been hypothesized that although the GIC sealants appear clinically as 'partially' or 'totally' lost, the opening of the fissures remains sealed [Oong et al., 2008]. In addition, the effectiveness of GIC has been attributed to the isolation of bacteria from nutrients in sealed lesions; the release of fluoride into the dentine or a combination of both factors [Oong et al., 2008]. In contrast, resin-based FS have been shown to lose almost all of their protective effect once their retention is lost [Beiruti et al., 2006]. Hence, the measured outcome of interest when comparing RM-GIC and resin-based FS should be caries incidence/increment or caries presence/ absence rather than retention of the sealant material. The meta-analyses presented in Figures 1-3 used a random effects model. This model is recommended over a fixed-effect model when heterogeneity is suspected; even after qualitative assessment for clinical and methodological heterogeneity suggests that the data from different trials could be pooled together [Higgins et al., 2003]. This usually is the case in trials having large variations in the size and direction of the treatment effect. After the pooled result is obtained and reflected in the form of a forest plot (Figures 1-3), statistical heterogeneity needs to be assessed [Higgins et al., 2003]. If this occurs (usually reflected as a high I2 value above 75%) and a significant p-value (below 0.10), then a suitable explanation is required as to whether genuine clinical or methodological differences exist between the pooled datasets. In the case of Figure 3, the statistical heterogeneity (I2 = 85.1%, p = 0.009) can be explained by the inconsistency in the observed treatment effect across the two datasets. The Raadal et al. [1996] trial found slightly in favour of the resin-based FS, whilst the trial by Pardi et al. [2005] favoured RM-GIC FS for the same outcome (Figure 3). For Figure 1, the test for heterogeneity did not apply, as the pooled result comprised results from only one estimable dataset. The result of a dataset is regarded as 'not estimable' when data (n/N) from the test- and the control group are identical, with a subsequent Relative Risk (RR) of 1.00. Figure 2 reflects a moderate I2 value (48.3%), with a p-value of 0.12 that suggests little variation in the size and direction of the treatment effect across pooled datasets. [FIGURE 1 OMITTED] [FIGURE 2 OMITTED] [FIGURE 3 OMITTED] Conclusion This systematic review with meta-analysis found no evidence that either material was superior to the other in preventing dental caries. Therefore, both materials appear to be equally suitable for clinical application as FS for a period of up to 2 years. However, the poor quality of the included trials warrants that further high-quality randomised control trials are needed to obtain conclusive evidence of equivalence or difference in caries prevention. Further trials should also investigate the long-term caries preventive effect of both materials beyond the period of 2 years. Trial reporting should follow the CONSORT statement [Moher et al., 2001] and, particularly, include a clear description of how the randomised allocation of study subjects to test- and control groups was conducted; state who generated the allocation sequence, who enrolled the subjects and who assigned subjects to their groups. Reporting should further include information about whether such allocation was concealed from the clinical operators until interventions were assigned and, if it was, about how such concealment was done. Reports should indicate, where possible, whether assessment of the treatment outcome was conducted by evaluators who were blinded to allocation of the study subjects into groups and also discuss details of any possible confounding factors with potential influence on the observed treatment effect. Acknowledgement The authors like to thank Dr Luciana Oliveira from the Sao Leopoldo Mandic Research Center, Campinas, Sao Paulo, Brazil for conducting the literature search in the Lusophone databases. References Adair SM. The role of sealants in caries prevention programs. J Calif Dent Assoc 2003;31:221-227. Ahovuo-Saloranta A, Hiiri A, Nordblad A, Makela M, Worthington HV. Pit and fissure sealants for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst 2008; Rev 4, CD001830. Beiruti N, Frencken JE, van't Hof MA, van Palenstein Helderman WH. Caries-preventive effect of resin-based and glass ionomer sealants over time: a systematic review. Community Dent Oral Epidemiol 2006;34:403-409. Bishara SE, Oonsombat C, Ajlouni R, Denehy G. The effect of saliva contamination on shear bond strength of orthodontic brackets when using a self-etch primer. Angle Orthod 2002;72:554-557. Chalmers TC, Matta RJ, Smith H Jr, Kunzler AM. Evidence favoring the use of anticoagulants in the hospital phase of acute myocardial infarction. N Engl J Med 1977;297:1091-1096. Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res 2000;79:1850-56. Forss H, Halme E. Retention of a glass ionomer cement and a resin-based fissure sealant and effect on carious outcome after 7 years. Community Dent Oral Epidemiol 1998;26:21-25. Higgins JPT, Thompsom SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. Brit Med J 2003;327:557-560. Ikeda K, Fujishima A, Suzuki M, et al. Resin content in cement liquids of resin-modified glass ionomers. Dent Mater J 1999;18:248-258. Juni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. Brit Med J 2001;323:42-6. Kantovitz KR, Pascon FM, Correr GM, et al. Inhibition of mineral loss at the enamel/sealant interface of fissures sealed with fluoride- and non-fluoride containing dental materials in vitro. Acta Odontol Scand 2006;64:376-383. Kilpatrick NM, Murray JJ, McCabe JF. A clinical comparison of a light cured glass ionomer sealant restoration with a composite sealant restoration. J Dent 1996;24:399-405. Kitchens DH. The Economics of pit and fissure sealants in preventive dentistry: A Review. J Contemp Dent Pract 2005;6:95-103. Mejare I, Lingstrom P, Petersson LG, et al. Caries-preventive effect of fissure sealants: a systematic review. Acta Odontol Scand 2003;61:321-330. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel--group randomised trials. Lancet 2001;357:1191-1194. Oliveira FS, da Silva SM, Machado MA, et al. Resin-modified glass ionomer cement and a resin-based material as occlusal sealants: a longitudinal clinical performance. ASDC J Dent Child 2008;75:134-143. Oong EM, Griffin SO, Kohn WG, Gooch BF, Caufield PW. The effect of dental sealants on bacteria levels in caries lesions: a review of the evidence. J Am Dent Assoc 2008;139: 271-278. Pardi V, Pereira AC, Ambrosano GM, Meneghim Mde C. Clinical evaluation of three different materials used as pit and fissure sealant: 24-months results. J Clin Pediatr Dent 2005;29:133-137. Raadal M, Utkilen AB, Nilsen OL. Fissure sealing with a light-cured resin-reinforced glass-ionomer cement (Vitrebond) compared with a resin sealant. Int J Paediatr Dent 1996;6:235-239. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. J Am Med Assoc 1995;273: 408-412. Smales RJ, Wong KC. 2-year clinical performance of a resin-modified glass ionomer sealant. Am J Dent 1999;12:59-61. Smith DC. Development of glass-ionomer cement systems. Biomaterials 1998;19:467-478. Songpaisan Y, Bratthall D, Phantumvanit P, Somridhivej Y. Effects of glass ionomer cement, resin-based pit and fissure sealant and HF applications on occlusal caries in a developing country field trial. Community Dent Oral Epidemiol 1995; 23:25-29. Sprague S, McKay P, Thoma A. Study design and hierarchy of evidence for surgical decision making. Clin Plast Surg 2008;35:195-205. Sutherland SE. Evidence-based dentistry: Part V. Critical appraisal of the dental literature: papers about therapy. J Can Dent Assoc 2001;67: 442-445. Tantbirojn D, Douglas WH, Versluis A. Inhibitive effect of a resin-modified glass ionomer cement on remote enamel artificial caries. Caries Res 1997;31:275-280. The Cochrane Collaboration. Cochrane handbook for systematic reviews of interventions 4.2.6. The Cochrane Collaboration 2006, pp 136-145. The Grade working group. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490. Thompson SG. Why sources of heterogeneity in meta-analysis should be investigated. BMJ 1994;309:1351-1355. Williams B, Laxton L, Holt RD, Winter GB. Fissure sealants: a 4-year clinical trial comparing an experimental glass polyalkenoate cement with a bis glycidyl methacrylate resin used as fissure sealant. Br Dent J 1996; 180:104-108. Winkler MM, Deschepper EJ, Dean JA, Moore BK, Cochran MA, Ewoldsen N. Using a resin-modified glass ionomer as an occlusal sealant: a one-year clinical study. J Am Dent Assoc 1996;127:1508-1514. Yengopal V, Mickenautsch S, Bezerra AC, Leal SC. Caries-preventive effect of glass ionomer and resin-based fissure sealants on permanent teeth: a meta analysis. J Oral Sci 2009;51:373-382. V. Yengopal, S. Mickenautsch Division of Public Oral Health, University of the Witwatersrand Johannesburg, South Africa Postal address: Dr S Mickenautsch. Division of Public Oral Health, University of the Witwatersrand, 7 York Rd., Parktown/Johannesburg, 2193, South Africa Email: neem@global.co.za Table 1. Quality assessment of included trials comparing resin-
modified glass-ionomer cements versus resin-based materials as
fissure sealants.
Selection bias Detection
bias
Article Random Allocation Evaluator
allocation concealment Blinding
Oliveira et al., 2008 B B D
Pardi et al., 2005 B B D
Smalles and Wong, 1999 B B D
Raadal et al., 1996 B B D
Kilpatrick et al., 1996 B B D
Winkler et al., 1996 B B D
Article Completeness
to follow-up
Oliveira et al., 2008 A (start n = 108; 6 months n = 98;
12 months n = 88)
Pardi et al., 2005 A (at start 356 teeth; end n = 329
Smalles and Wong, 1999 A (start n = 14; end n = 14)
Raadal et al., 1996 A (start n = 53; end n = 53)
Kilpatrick et al., 1996 A (start n = 76; end n = 58)
Winkler et al., 1996 A (start n = 50; 6 months n = 43;
12 months n = 40
n = Number of patients.
Table 2. Characteristics of data sets (DS) with potential influence
on study outcome--Part I.
Article DS 2-arm Test Control
study material material
design (RM-GIC) (Resin-
based)
Oliveira et 01 PG--I Vitremer Delton
al., 2008 02
03
04
05
06
07
08
Pardi et 09 PG--I Vitremer Revolution
al., 2005 10
Smales and 11 Not K-512 (Fuji Delton
Wong, 1999 reported III LC)
Raadal et 12 SG Vitrebond Concise
al., 1996 13
14
15
16
Kilpatrick 17 PG--II Vitrebond Concise
et al., 1996
Winkler et 18 SG Fuji II LC Concise
al., 1996 19
Article DS Outcome measure Patient /
age, gender
Aspect Definition
Oliveira et 01 Caries No softness, Age: Mean
al., 2008 02 absence no opacity, 7.5 (SD
03 no etch on 1.25) years,
04 enamel Range 5-10
05 years
06 Gender: no
07 info
08
Pardi et 09 Caries No visible Age: 7-8
al., 2005 10 absence caries' years
Gender: no
info
Smales and 11 Caries No softness, Age: Mean 22
Wong, 1999 absence no opacity, years, Range
no etch on 15-27 years
enamel
Gender: 12
female/7
male
Raadal et 12 Caries Caries Age: Range
al., 1996 13 absence diagnostic 5-7 and 11-
14 criteria by 13 years
15 Moller,
16 Grades '0' Gender: 29
and '1' female/24
male
Kilpatrick 17 Caries Caries Pediatric
et al., 1996 absence absent' patients
and older
patients
with
learning
difficulties
or
development
delays
Winkler et 18 Caries No softness, Age: Range
al., 1996 19 absence no opacity, 7-10 and
no etch on years
enamel
Gender: no
info
Article DS Dentition Type of Follow-up
tooth period
Oliveira et 01 Permanent 1st Molar 6 months
al., 2008 02 teeth 12 months
03
04
05
06
07
08
Pardi et 09 Permanent 1st Molar 12 months
al., 2005 10 teeth 24 months
Smales and 11 Permanent No info 24 months
Wong, 1999
Raadal et 12 Permanent 1st/2nd 1 months
al., 1996 13 Molars 1 6 months
14 month 12 months
15 24 months
16 36 months
Kilpatrick 17 Permanent Premolar 27 months
et al., 1996 teeth
Winkler et 18 Permanent 1st Molar 6 months
al., 1996 19 teeth 12 months
PG-I = Parallel group design with patients as unit of investigation;
PG-II = Parallel group design with sealed teeth as unit of
investigation; SG = Splitmouth design; SD = Standard deviation.
Table 2. Characteristics of data sets (DS) with potential influence
on study outcome--Part II.
Article DS Caries Fluoride RM-GIC
activity, exposure powder/
risk or liquid
preva- mixture
lence (Ratio)
Oliveira 01 Groups No info 0.25 : 1
matched per
dmft/ DMFT
et al., 2008 02 1 : 1
0.25 : 1
03
1 : 1
04
0.25 : 1
05
1 : 1
06
0.25 : 1
07
1 : 1
08
Pardi et 09 Caries free No info 1 : 2
al., 2005 10 teeth
Smales and 11 No info No info No info
Wong, 1999
Raadal et 12 Caries free No info No info
al., 1996
13 teeth
14
15
16
Kilpatrick 17 Teeth with No info No info
et al., 1996 early
carious
lesions
Winkler et 18 Caries free No info No info
al., 1996 19 teeth
Article DS Moisture control
Oliveira 01 Delton applied under moisture control with
rubber dam
et al., 2008 02 Delton applied under moisture control with
rubber dam
Delton applied under moisture control with
03 cotton wool rolls
Delton applied under moisture control with
04 cotton wool rolls
Delton applied under moisture control with
05 rubber dam
Delton applied under moisture control with
06 rubber dam
Delton applied under moisture control with
07 cotton wool rolls
Delton applied under moisture control with
08 cotton wool rolls
Pardi et 09 Moisture control with cotton wool rolls
al., 2005 10
Smales and 11 No info
Wong, 1999
Raadal et 12 Moisture control with cotton wool rolls
al., 1996
13
14
15
16
Kilpatrick 17 Moisture control with cotton wool rolls
et al., 1996 or rubber dam
Winkler et 18 Moisture control with cotton wool rolls
or rubber dam
al., 1996 19
Article DS Material Process of Presentation
re-appli- outcome of results
cation measure-
ment
Oliveira 01 No Clinical In
examination percentages,
number of
et al., 2008 02 teeth
calculated
by hand
03
04
05
06
07
08
Pardi et 09 No Clinical Number of
al., 2005 10 examination teeth
reported
Smales and 11 No Bitewing Number of
Wong, 1999 radiographs teeth
reported
Raadal et 12 No Clinical Number of
al., 1996 examination, teeth
13 bitewing reported
radiographs
14
15
16
Kilpatrick 17 Yes Clinical Number of
et al., 1996 examination teeth
reported
Winkler et 18 No Clinical Number of
al., 1996 19 examination teeth
reported
Table 3. Results of datasets not included in the meta-analyses.
Article DS RM-GIC Resin
n N n N
Oliveira et al., 2008 01 51 51 34 34
03 51 51 51 51
05 51 51 34 34
07 51 51 48 51
Smales and Wong, 1999 11 46 47 38 41
Raadal et al., 1996 12 136 136 136 136
16 126 136 136 136
Kilpatrick et al., 1996 17 66 66 66 66
Article DS RR 95%CI p-value
Oliveira et al., 2008 01 1.00 = =
03 1.00 = =
05 1.00 = =
07 1.06 0.98, 1.15 0.13
Smales and Wong, 1999 11 1.06 0.96, 1.16 0.26
Raadal et al., 1996 12 1.00 = =
16 0.93 0.88, 0.97 * 0.002 *
Kilpatrick et al., 1996 17 1.00 = =
DS = Dataset number; RM-GIC = Resin-modified glass-ionomer cement;
Resin = Resin-based material; n = number of caries free sealed
teeth; N = Total number of sealed teeth evaluated; RR = Relative
risk; CI = Confidence interval; * Statistically significant
difference in favour of resin. |
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