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DOI: 10.1177/00220345990780020101
1999 78: 628J DENT RESR.C. Randall and N.H.F. Wilson
Glass-ionomer Restoratives: A Systematic Review of a Secondary Caries Treatment Effect
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CONCISE REVIEW
Glass-ionomer Restoratives:A Systematic Reviewof a Secondary Caries Treatment EffectR.C. Randall* and N.H.F. Wilson
Restorative Dentistry, Manchester University Turner Dental School, Higher Cambridge Street, Manchester, M15 6PH, United Kingdom;*corresponding author
Abstract. It is generally accepted that glass ionomers inhibitsecondary caries in vivo, and data from in vitro studiessupport this effect. The aim of this review was a systematicassessment, from the literature, of clinical evidence for theability of glass-ionomer restoratives to inhibit secondarycaries at the restoration margin. Inclusion and exclusioncriteria for selection of the review papers were establishedprior to commencement of the literature search. Paperswhich conformed to these criteria, and reported onsecondary caries as an outcome, were selected (N = 52).Primary and secondary lists of systematic criteria for use inthe assessment of the papers were drawn up. The primarylist of 14 criteria was applied to each paper. No paperfulfilled all these criteria, necessitating the use of thesecondary measures: (i) a prospective study and (ii) use ofan appropriate control. This yielded 28 papers. Tabulationof these papers by occurrence of secondary caries in theglass-ionomer or control groups demonstrated an evendistribution between positive and negative outcomes. Validevidence is considered to be best obtained from ran-domized, controlled studies of sufficient sample size. Noconclusive evidence for or against a treatment effect ofinhibition of secondary caries by the glass-ionomerrestoratives was obtained from the systematic review. Thereis a need for appraisal of the methods currently adopted forthe clinical evaluation of glass-ionomer restorativematerials, and for further development of the methodologyto support future systematic reviews.
Key words: systematic review, glass ionomer, secondarycaries.
Received March 14, 1997; Last Revision March 9, 1998;Accepted April 9, 1998
Introduction
There is increasing interest in evidence-based treatment indentistry (Antczak-Bouckoms et al., 1994; Richards andLawrence, 1995), echoing similar discussions in medicine.The intention of this approach is to base treatment decisionsfor patients on a combined use of current best evidence andindividual clinical expertise (Sackett et al., 1996). Theapplication of treatments for which valid evidence ofeffectiveness is judged to have been established furthers theprovision of quality in patient care and justifies its cost(Fahey et al., 1995; Richards and Lawrence, 1995; Sackett ctal., 1996). In clinical research, randomized, controlledclinical trials are considered to be the 'gold standard' fromwhich evidence for treatment benefit can be obtained(Davidoff et al., 1995; Sackett et al., 1996).
The Cochrane Collaboration dental group providesevidence for the efficacy of treatments in periodontologythrough publication of systematic reviews (Antczak-Bouckoms et al., 1994). Studies to be included in theirreviews are selected by means of the systematic applicationof a predetermined list of specific criteria. Each criterionchosen is considered to be necessary for a well-designedstudy. A systematic review is an objective summary of thefindings from all known, well-conducted, clinical investi-gations on the subject in question (Davidoff, 1995). Therationale is that the same scientific principles of objectivitythat are applied to the conduct of primary research are alsoapplied to a review of that research (Mulrow, 1987).
It is generally well-accepted that glass ionomers inhibitsecondary caries in vivo. Data from in vitro studies supportthis effect, but there is no clear indication from clinicalstudies to corroborate it. There is a need to establishwhether clinical evidence for a protective effect of glassionomers exists. The aim of this review, therefore, was toassess systematically, from the available literature, theclinical evidence for the ability of glass-ionomer restorativesto inhibit secondary caries at the restoration margin.
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Systematic Review of Glass-ionomer Treatment Effect
Materials and methodsInclusion and exclusion criteria for the selection of papers forreview were established prior to commencement of the litera-ture search. The inclusion criteria consisted of written clinicalevaluations of all classes of restorations of glass ionomer in bothpermanent and primary teeth, including tunnel preparationsand 'open sandwich' or laminate restorations. Only 'true' glass-ionomer restoratives-that is, materials whose settingmechanism depends wholly or partly on an acid-basereaction-were considered, thus encompassing conventionalglass-ionomer cements and resin-modified glass ionomers.Excluded were studies involving glass-ionomer core build-ups,luting cements, fissure sealants, liners and bases used in a'closed sandwich' procedure, endodontic filling pastes, andorthodontic band and bracket cements. Evaluations ofrestorations of fluoride-releasing composites and fluoride-releasing amalgams were also omitted. A literature search ofpublications dating from 1970 to May, 1996, in two databases-MEDLINE and Excerpta Medica-was conducted, and indatabases held by the dental school libraries of Nijmegen andGothenburg Universities. It is known that searches of electronicdatabases often retrieve only a portion of the relevant titlesbecause of inaccurate indexing (Antczak-Bouckoms et al., 1994).To help identify as many papers as possible, we carried outsome hand-searching of journals. Key words used were "clinicaltrial", "clinical evaluation", "in vivo", "glass ionomer", and"glass polyalkenoate". Searches were made for both English-and non-English-language publications. The only relevant, non-English papers found were in German; these papers weretranslated. From the titles and abstracts of papers so generated,copies of papers fulfilling the inclusion criteria were acquired,together with copies of papers with ambiguous titles which mayhave been relevant to the review. To standardize the evaluationof papers selected for review, we established 14 criteria for useas a systematic assessment list.
Systematic assessment list(a) Prospective study.(b) A stated aim/purpose and/or hypothesis.(c) Justification for sample size used in the study.(d) Indications of source of patient sample.(e) Inclusion criteria.(f) Exclusion criteria.(g) Use of an appropriate control treatment.(h) Randomization to treatment groups.(i) Description of randomization method used.(j) More than one examiner for direct clinical evaluations.(k) Examiner calibration.(1) Report on patient loss from the study and reasons; or(m) 100% patient recall rate.(n) Report on whether other protocol deviations had occurred.
Should the case have arisen that the systematic assessmentresulted in no, or only a limited number of, studies fulfilling allthe criteria, a second selection based on only two criteria wasdrawn up: (1) prospective study and (2) use of an appropriatecontrol treatment.
The systematic assessment criteria were by turn applied toeach paper which reported on clinical diagnosis of secondarycaries as a study outcome.
629
ResultsRelevant references cited in the papers (English-languageonly) were obtained if they had not been included in theoriginal database lists. Hand-searching of journals yieldedthree additional papers. Five of the German papers includeddocumentation of secondary caries (Kullman and Freers,1984; Staehle, 1984; Engelsmann et al., 1988; Hickel et al.,1988; Reich, 1991). No relevant papers published in Dutch orany Scandinavian language were traced. Three abstractswere obtained that preceded a paper on the same data, andthe abstracts (Osborne et al., 1985; Kaurich et al., 1989; vanDijken, 1994a) were discarded in favor of the papers(Osborne and Berry, 1990; Kaurich et al., 1991; van Dijken,1994b). Two studies had been published in two stages: two-year (Walls et al., 1988) followed by five-year results(Welbury et al., 1991); and a six-month report (Charbeneauand Bozell, 1979) followed by 41/2 -year results (Brandau etal., 1984). Only the longer-term evaluations were included inthe review. Two papers published by Levy et al. gave one-
year (Levy et al., 1989) and two-year data (Levy and Jensen,1990) for the same study. Since the authors did not reportsecondary caries as a cumulative result at two years, datafrom both publications were combined. Of the total numberof studies obtained, 52 (72%) reported on secondary cariesas an outcome measure. Results of the application of thesystematic assessment criteria to these studies are tabulatedas Table 1.
Forty papers reported prospective studies (Table 1,Prospective study). Forty-nine papers cited an aim (Table 1,Stated aim/purpose and/or hypothesis); only two papersalso construed the aim in the form of a null hypothesis(Wood et al., 1993; Kilpatrick et al., 1995). Two papers didnot clearly state an aim (Smales, 1981; Ngo et al., 1986).
In no paper was justification given for the sample sizeused.
Sixteen studies recruited subjects from outpatient dentalclinics or dental school departments (Table 1, Indication ofpatient source [1]); five evaluations were based uponpatients who attended the investigator's private practice(Table 1, Indication of patient source [2]), and one studyrecruited patients from the pupil population of a secondaryschool (Smith et al., 1990).
Inclusion criteria were more often provided thanexclusion criteria, the degree of detail given varyingbetween papers. Fourteen studies indicated a requirementfor patients needing two or more restorations (Table 1,Inclusion criteria [1]), ten papers specified a minimum ormaximum cavity size or depth required for inclusion (Table1, Inclusion criteria [2]), five papers stated that, foracceptance into the study, cavities had to be lesions ofprimary caries only (Table 1, Inclusion criteria [3]), whereasthree further studies accepted both primary caries andreplacement restorations (Grogono et al., 1990; Welbury andMurray, 1990; Welbury et al., 1991). Nine papers specifiednon-carious cervical lesions (Table 1, Inclusion criteria [4]),four papers root caries lesions (Billings et al., 1985; Levy etal., 1990; Kaurich et al., 1991; Wood et al., 1993), and onestudy included both caries-free erosions and root carieslesions (Reich, 1991). Two studies stipulated that all
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630 Randall & Wilson
Table 1. Results of application of sy,Indication of patient source: 1, patieoutpatient dental clinic; 2, patients ainvestigator's private practice.
Inclusion criteria: 1, two or more res2, minimum or maximum cavity sizstipulated; 3, primary caries lesionsnon-carious cervical lesions only.
Use of appropriate control:1, amalgam control;2, composite control.
J Dent Res 78(2) 1999
stematic criteria.nts attending an
ittending the 04
;torations;\0 $'JN 4.A C
,e or depth0 q,0 .only;4
4qjI
c .v
'lk
0
,McLean iet al, 1977 T - - /4 - - - - I-
SilIulCs, 1981
BrndII-ilai ict al, 1984 ]'2/,4 /
St:chlec, 1984 /
illings et aL, 1985 1 V I / / /
Knibbs et al, 1986 / /2 |/4
Motiiit, 19S86 Iv-/-Voat, 1986/
2
Ngocltl I I /2V/I
Knibbs, 1987 ! / V/2!n clsiltClIa, 1988 / /VI1
lticktelcet , 1988 / V-lorstedl-Bind(slev et al, 1988 / / /4 /2 / /
Levy ct al, 1989, 1990 j / / /2 /2 | v
F'orstell ct al, 199(1 / |/ l | 1,/1,2 |
Grogonocl,19() K / - -l / l/2 / T T
inaget al, 1990 / / /II -v/
L.ova,diflo C, aI, 1990 / / / / /I
O)sborinect a, 19990 / /1 / /2 / /2
SillIles et al, 199( / /2 / I
Smliithi ct al, 1990 / I/ / '/ /
elburybciet:la, 19(91 / / /1 /4
1(aurichlet:-I,199l / / / 1,2,3 / /2 / l
etcichi, 1991 / I2T;vas, 1991 / /- /2 / /
WelIt1)rLII tal. 1'99)1 | / - / /1 -|-1|-|------EC-|-|
prepared cavity margins must be in enamel (Ostlund et al.,1992; Mjor and Jokstad, 1993), and three studies that therestored teeth be in occlusion (Lidums et al., 1993; Wilkie etal., 1993; van Dijken, 1994b). Exclusion criteria werespecifically mentioned in five papers; three described theextent of caries that would exclude a tooth from the study(Lovadino et al., 1990; Welbury et al., 1991; Ostlund et al.,1992), and two cited a patient's medical history as grounds
for exclusion (Os-borne and Berry,1990; Kaurich et al.,1991).
For the purposesof this review, anappropriate controltreatment was con-sidered to be eitheran amalgam or acomposite restor-ation; use of anotherglass ionomer as acontrol was notdeemed to be validfor comparison oftreatment effectsagainst secondarycaries. Twelve stud-ies included amal-gam restorations(Table 1, Use of ap-propriate control[1]) and 14 studiescomposite restor-ations as controls(Table 1, Use of ap-propriate control[2]). Four studiesencompassed both(Ostlund et al., 1992;Lidums et al., 1993;Mjbr and Jokstad,1993; Wilkie et al.,1993).
Seventeen in-vestigations statedthat treatments hadbeen randomized tocavities (Table 1,
Randomization to treatment groups). The method ofrandomization used was described in four papers: Threestudies utilized computer-generated random numbers (Tyas,1991; Welbury et al., 1991; Matis et al., 1996), and in the fourthstudy, restorative materials were allocated on alternativeweeks (Qvist et al., 1995). Because this latter method permitsthe operator to have prior knowledge of assignments ofmaterials, it was not considered to be true randomization.
ff ff ff Ir ff ff Ir ff ff ff ff ff
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Systematic Review of Glass-ionomer Treatment Effect 631
Table 1 (continued)
44
.09 .0
'N ,I
c1c4.0': l4 ?. %,4,0
Knibl)s, 1992 VI"// I / /2 /
I(Cnight, 1992 /
6stlund et al, 1992 / $ /1 /2,3 / / / / / /
SN\1bcrgX, 1992 f I/1 / 1,2,3 / I / /
l-lisselrot, 1993 / /2
Li(dums et al, 1993 V/ / /j / /
Ni.Mj-i et al, 1993 I/ /f /2,3 / -Wilkicetal, 1993 I/ / /2 / /
~---Woo(l ;al, 1993 V / /1 /j / / / /
v;l}~-xlel- 'e4 - - --------- --a- -v;11 )ijken, 19941) / / 2
IMLkict al, 1994 / / 11Qvisl et al, 1994 -1 / /
Anderss)ll-NtIlCl;kert et -Il, 19951/ " /
Croll et a11, 1995
vailDijkeiu, 1995 / /2
Ispelid et -I, 1995 V /
KilpatrickeltI, 1995 V 1'v1I,3 / /Luiiileyet al, 1995 / / /2 =-- ,/Maneenut and Tyas, 1995 / - /4=/Powell et Al, 1 99-5 / V - /1,2, =/2 /
Ovist cl al, 1995 // V
Schwartz et al, 1995 - 2 = / -
v.a 1)ikjen, 1996 -4 -
)oilh, et al, 1996 -- =
M'1atis et Al, 1996 I I /1,4 /2 / / / / /
Neo ettl, 1996 = 1.4 v/ 2 --
Clinical evaluations of study restorations were carriedout by more than one examiner in 17 reports (Table 1, Morethan one examiner).
Twelve papers reported on the number and reasons forpatient loss from the study (Table 1, Reasons for patient lossfrom study), and in nine papers the patient recall rate wasrecorded as being 100% (Table 1, 100% patient recall). Other
than patient drop-out from the study,only one paper ad-dressed the subjectof deviation fromthe protocol to in-dicate whether ornot this had occur-red (Wood et al.,1993).
Since no studyfulfilled all the sys-tematic review cri-teria, the secondaryassessment list-(1)a prospective studyand 2) use of ap-propriate controlwas applied. Thesecriteria yielded 28studies (see Table2 for references),which were groupedinto four categoriesbased on the re-
ported instances ofrecurrent caries inthe control andgl as s -i onomergroups. In addition,data were includedto indicate: (i)whether random-ization of treatmentsto teeth had beencarried out, (ii) thesize of trial asevidenced by thenumber of restora-tions evaluated atbaseline and at final
recall, (iii) whether a follow-up report on patient drop-outfrom the study was given, or there was a 100% recall rate,and (iv) the duration of the study (Table 2). The categorieswere defined as:(1) No secondary caries in the glass-ionomer group; secon-
dary caries present in the control group.(2) No secondary caries in either the glass-ionomer or con-
y I I I r
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632 Randall & Wilson
Table 2. Results of application of secondary assessment criteria
Reference and Secondary Caries Randomized No. at No. at Last Patient LossStudy Duration GI Control ? Baseline Recall Evaluation
Category 1Kulayn Fres,18
Kullman and Freers, 19846 months
Lovadino et al., 19902 yrs
Ostlund et al., 19923 yrs
Svanberg, 19923 yrs
Wood et al., 19936 months
Category 2
Horsted-Bindslev et al., 19883 yrs
Grogono et al., 19902 yrs
Osborne and Berry, 19903 yrs
Smith et al., 19901 yr
Reich, 19911 yr
Lidums et al., 19932 yrs
Wilkie et al., 19932 yrs
van Dijken, 19951 yr
Matis et al., 199610yrs
Neo et al., 199618 months
0 2A
0 3A
0 1A3C
0 3A
0 6A
0 OC
0 OC
0 OC
0 OC
0 OC
0 OAOC
0 OCOA
0 0C1
0 OC
0 OC
trol group.(3) Secondary caries in the glass-ionomer group; no
secondary caries present in the control group.(4) Secondary caries present in both glass-ionomer and
control groups.The grouping of all 28 papers by category only is set out
in Table 3. Within the constraints that the papers can becompared only at a simplistic level-that is, they are allprospective studies and utilize a control appropriate to the
review being undertaken-Table 3 shows a surprisinglyeven distribution between positive and negative outcomesof incidence of secondary caries in association with glass-ionomer restorations and the controls.
DiscussionA secondary caries treatment effect could be expected to beaccentuated in groups of patients with a high risk of caries.Two investigations specifically involved high-caries-risk
n/s
n/s
yes
yes
n/s
yes
yes
yes
n/s
n/s
n/s
n/s
n/s
yes
yes
39 GI39 A
32 GI32 A
25 GI25 A25 C
18GI18A
54 GI54 A
22 GI50 C
20 GI20 C
48 GI24 C
107 GI99 A
20 GI57 C
57 GI21 A38 C
42 GI16A28 C
55 GI114 C
90 GI29 C
42 GI41 C
38 GI38 A
26 GI26 A
10GI23 A19C
100% recall
8 GI8A
(subgroup)
15GI34 C
19 GI19C
44 GI22 C
98 GI88 A
19 GI48 C
30 GI17A8C
16GI13A1C
46 GI3C
100% recall
no
no
yes
n/a
yes
yes
no
no
yes
no
no
no
n/s
yes
n/a
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Systematic Review of Glass-ionomer Treatment Effect
Table 2 (continued)
Reference and Secondary Caries Randomized No. at No. at Last Patient LossStudy Duration GI Control ? Baseline Recall Evaluation
Category 3
Hung and Richardson, 19901 yr
Knibbs, 19922 yrs
Lumley and Fisher, 19955 yrs
Schwartz et al., 19951 yr
Category 4
Levy et al., 1989;Levy and Jensen, 19902 yrs
Kaurich et al., 19912 yrs
Tyas, 19915 yrs
Welbury et al., 1991av. 2 yrs
Mj6r and Jokstad, 19935 yrs
1
1
OA
OC
OA
OC
5
1
1 5C
2C
2% 11%C
7 11A
2
van Dijken, 1994b6 yrs
Qvist et al., 19942 yrs
Powell et al., 19953 yrs
Donly and Kanellis, 19962 yrs
1 A5C
2 Cl3C
5A2
3% 10% C
2 3A
Key: GI, glass-ionomer; A, amalgam; C, composite; CI, composite inlay; n/s, not stated; n/a, not applicable.lPersonal communication.
individuals (Wood et al., 1993; van Dijken, 1994b) (Table 4).The study by Wood et al. was of xerostomic patients. Theauthors categorized the severity of xerostomia as high,medium, or low. A subgroup of eight patients, who did notregularly use the recommended fluoride rinsing regime, wasevaluated separately for incidence of secondary caries, withthe amalgam restorations compared with the glass-ionomerrestorations (Wood et al., 1993). In the study by van Dijken,patients were screened for caries-risk status by means of anestimate of the net effects of oral hygiene, dietary carbohy-drates, salivary microbial counts, and saliva flow rate andbuffer value (van Dijken, 1994b). Eighteen out of the total
sample size of 40 patients were considered to be at highcaries risk. Among those restorations which subsequentlydeveloped secondary caries, all except one were from thishigh-caries-risk group.
Four of the 28 studies rated in Table 3 reported on caries-free erosion/abrasion lesions (Horsted-Bindslev et al., 1988;Powell et al., 1995; Matis et al., 1996; Neo et al., 1996).Excluding these studies from Table 3 changes the scores inthe 'Number of Studies' column to: Category 1 = 5, category2 = 7, category 3 = 4, and category 4 = 8. The distributionbalance between positive and negative outcomes for an anti-caries effect of glass-ionomer restoratives, however, remains
yes
n/s
n/s
n/s
yes
yes
yes
yes
n/s
n/s
yes
n/s
n/s
40 GI33 A
32 GI32C
33 GI14A
76 GI70 C66 GI
45 GI59 C
27 GI27 C
65 GI67 C
119GI119 A
95 GI88 A91 C
16GI100 CI34 C
515 GI543 A
39 GI39 C
40 GI40 A
100% recall
20 GI20 C
100% recall
100% recall
20 GI34 C
23 GI23 C
99 GI99 A
44 GI33 A36 C
100% recall
281 GI351 A
37 GI37 C
20 GI20 A
n/a
no
n/a
n/a
partial
yes
no
no
partial
n/a
partial
yes
no
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634 Randall & Wilson
Table 3. Second-level assessment-papers grouped by incidence ofsecondary caries
Secondary CariesGlass Number
Category Ionomer Control of Studies
1 0 / 52 0 0 103 / 0 44 / / 9
N = 28 (see Table 2 for references).Key: 0, no secondary caries reported; /, secondary caries reported;
Category 1, no secondary caries in the glass-ionomer group,and secondary caries in the control group; Category 2, nosecondary caries in either glass-ionomer or control groups;Category 3, secondary caries in the glass-ionomer group andno secondary caries in the control group; and Category 4,secondary caries in both glass-ionomer and control groups.
unchanged.Many of the studies used small sample sizes. Evaluating
a small number of patients or restorations can minimize thepower of a study (Begg and Berlin, 1989), so that a clinicallyimportant difference between two materials which may bepresent is not detected, and the results obtained indicate noapparent difference (Type II error). The reverse situation canalso arise, where there is, in fact, no difference between thematerials but the data yield a significant difference inoutcome (Type I error). Such results occur by chance andcan be misleading. Evaluations by Smith et al. (1990),Welbury et al. (1991), and Qvist et al. (1994) had the largestsample sizes of the studies in Table 2. Data from thesestudies are given in Table 5.
Randomization of treatments also increases the validityof results from a clinical study. If the method used toallocate treatments to teeth is operator choice, this can leadto serious bias regarding materials' selection (Pocock, 1983).A possible bias in an unrandomized study could haveoccurred if the operator always tended to place the glass-ionomer restorative in the tooth with the more recentlyactive caries and the control restorative in the tooth which
Table 4. Incidence of secondary caries in high-caries-risk studies
Ref. & No. of Restorations No. of RestorationsStudy at Final Recall with Secondary CariesDuration GI Control GI Control
Woodet al., 1993 8 8 (A) 0 66 months (subgroup) (subgroup)
van Dijken 16 100 (CI) 2 21994a6 yrs 34 (C) 3
Key: GI, glass ionomer; (A) amalgam; (CI) composite inlay; (C) compositE
had the more slowly progressing lesion. Randomizationsafeguards against such selection bias, since chance alonedetermines treatment assignments to cavities (Campbell andMachin, 1993). Bias in treatment assignment could have agreater influence on a study outcome than the treatmentunder evaluation (Chalmers et al., 1983). It is possible torandomize treatments and still have bias present, especiallyif the sample size is small. This problem can be reduced ifsubjects are first stratified-for example, by age or cariesactivity-and then treatments are randomized within thesegroups (Heifetz et al., 1985).
Of the studies in Table 2, three (Tyas, 1991; Welbury etal., 1991; Matis et al., 1996) indicated that randomization hadbeen conducted by means of computer-generated randomnumbers. Data from these studies are shown in Table 6.
There are other perspectives of study methodologywhich could be included in the discussion; however, samplesize, randomization of treatments, and use of an appropriatecontrol group are pivotal to obtaining valid results from aclinical trial assessing treatment effects. Interpretation ofdata from any subgroup, such as the seven studies in Tables4, 5, and 6, must necessarily be carried out with care (Bland,1995). It could be argued that these seven studies carry aweighting advantage over the main body of papers, andtheir results suggest that there is a clinically important effectof glass ionomers in reducing the incidence of secondarycaries. Taken as a whole, however, the data give no clearevidence for inhibition of secondary caries by glass-ionomerrestoratives, and equally, there is no evidence to indicatethat glass-ionomer restoratives do not inhibit secondarycaries. The lack of a conclusive indication of a treatmenteffect on secondary caries may be partly due to variability ofthe glass-ionomer restorative materials used; for example,fluoride and other ions' release, and bacteriostatic effects,may differ markedly between products. Further, the amountof fluoride required to prevent demineralization of enameland dentin is not precisely known but is believed to differbetween these tissues (Herkstroter et al., 1991). Root carieslesions may need a higher concentration of fluoride ion tostabilize demineralization compared with lesions in enamel(Dijkman et al., 1993).Two recent reports have documented dental
practitioners' reasons for replacement of restorations (Mjor,1996; Wilson et al., 1997). Clinicaldiagnosis of secondary caries wascited as the reason for replacement ofaround 50% and 30% of glass-ionomer restorations in the respectivestudies. The opinion of one of the
Randomized authors (Mjor, 1996), that theanticariogenic effects of glassionomers are poorly substantiated by
n/s clinical investigations, is confirmedby the present study.
Not all published papers onn/s clinical evaluations of glass-ionomer
restoratives will have been obtainedfor this review. There will be relevantpapers published in, for example,e;n/s, not stated. Japanese dental journals, but because
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Systematic Review of Glass-ionomer Treatment Effect 635
of translation difficulties, no search Table 5. Incidence ofwas carried out to trace these.Published literature as a whole is Ncconsidered to be biased toward Studypositive outcomes (Dickersin and GIMin, 1993), so any review of theliterature must also be assumed to be Qvist et al., 281similarly biased. The narrow aim 1994adopted for the present reviewdiffered from the primary aim of Welbury 99many of the papers being assessed, et al., 1991their scope being a broader one of fullclinical evaluation; consequently, the Smith et al., 98carry-over effect of any publication 1990bias in the literature reviewed here isconsidered to have been lessened. Key: GI, glass ionome
There is concern that the literatureincluded in this analysis did notstand up to systematic review. The assessment criteriaadopted would be considered rudimentary for appraisal ofa compilation of medical clinical trials, yet none of thepresently reviewed papers was found to satisfy all thecriteria applied. There will be exceptions, but it is antici-pated that many published reports on clinical evaluations ofdental restorative materials will be similar to the papersselected for review. Consideration should be given toassessing the methodology adopted for medical deviceclinical research and a move made to put in place animproved standard of clinical testing in dental restorativesresearch investigations. The expected increase in demandfor clinical evidence of efficacy in restorative materials andtechniques will focus attention on systematic reviewmethodologies. In anticipation of this, further developmentof systematic review criteria and their validation is needed.
Results from an analysis of a subgroup of the main bodyof retrieved papers, which had a weighting advantage,suggested a positive effect of glass-ionomer restorativesagainst secondary caries; however, no conclusive, overallevidence for or against a treatment effect of inhibition ofsecondary caries by glass-ionomer restoratives wasobtained.
There is a need for appraisal of the methodologycurrently adopted for the clinical evaluation of glass-ionomer restorative materials and its further developmentfor the support of future systematicreviews. Table 6. Incidence o
Acknowledgment NThis paper is based on a thesis Studysubmitted to the graduate faculty, GManchester University, in partial Matis et al. 4fulfillment of the requirements for the 1996MPhil degree.
Tyas, 1991
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