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1 The replacement or repair of posterior amalgam restorations: when is it indicated in the permanent dentition? An Evidence-Based Literature Review Submitted to: Dr. Carlos Quiñonez and Dr. James Leake Department of Community Dentistry, Faculty of Dentistry, University of Toronto Submitted by: Ji Hoon Hyun  Hon. B.Sc. Danielle Musselman  Hon. B.Sc. Kaveh Nedamat  Hon. B.Sc.  Natascha Rodrigues Michelle Wong Robert Wong In fulfillment of DEN207Y Community Dentistry academic requirements. Contact: Michelle Wong Faculty of Dentistry, University of Toronto 124 Edward Street, Toronto, Ontario, Canada M5G 1G6 (416) 97 9- 4750 ext. 35 59 [email protected] March 20, 2008 Word Count: 2778

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The replacement or repair of posterior 

amalgam restorations: when is it indicatedin the permanent dentition? 

An Evidence-Based Literature Review 

Submitted to:

Dr. Carlos Quiñonez and Dr. James Leake

Department of Community Dentistry, Faculty of Dentistry, University of Toronto

Submitted by:

Ji Hoon Hyun  Hon. B.Sc. 

Danielle Musselman  Hon. B.Sc. 

Kaveh Nedamat  Hon. B.Sc. 

 Natascha Rodrigues

Michelle WongRobert Wong

In fulfillment of DEN207Y Community Dentistry academic requirements.

Contact:

Michelle Wong

Faculty of Dentistry, University of Toronto

124 Edward Street, Toronto, Ontario, Canada M5G 1G6(416) 979- 4750 ext. 3559

[email protected] 

March 20, 2008

Word Count: 2778

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Table of Contents

Abstract ........................................................................................................................................... 3 Introduction..................................................................................................................................... 4 Methods........................................................................................................................................... 6 

Search Strategy ............................................................................................................................... .......... 6 Inclusion Criteria ............................................................................................................................... ....... 7 Exclusion Criteria ............................................................................................................................... ...... 7 Validity Instrument ............................................................................................................................... .... 7 Literature Search Results .......................................................................................................................... 8 

Results........................................................................................................................................... 10 Discussion..................................................................................................................................... 14 Conclusion .................................................................................................................................... 18 Appendix A:.................................................................................................................................. 19 Checklist to Assess Evidence of Efficacy of Therapy or Prevention ........................................... 19 Appendix B: Evidence Tables ..................................................................................................... 20 Appendix C: Paterson FM et al. Criteria ..................................................................................... 22 Appendix D: Hickel R et al.’s Criteria to evaluate restorations .................................................. 24 Acknowledgements....................................................................................................................... 27 References..................................................................................................................................... 28 

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Abstract

Dental practitioners are constantly faced with the decision to replace or repair a failed

 posterior amalgam restoration yet no set guidelines exist. The purpose of this paper is to conduct

an evidence-based literature review of when to replace or repair failed posterior amalgam

restorations in the permanent dentition. Eleven scientific electronic databases including Pubmed

and Ovid were searched using MeSH and relevant keywords. The search yielded a total of 4015

articles. Of these, 310 were found to be relevant after screening at the title stage and this number 

was further reduced to 53 based on the inclusion/exclusion criteria. Three articles were selected

for critical appraisal and validity scoring; ultimately, two articles were accepted to be of 

reasonable quality and study design. The studies indicate that repair is an acceptable and

conservative method of treating failed amalgam restorations; however, no comparative data on

longevity of repair versus replacement of amalgam is available. Unfortunately, there is an

insufficient body of evidence-based literature to make a recommendation as to when a posterior 

amalgam should be replaced or repaired. Future work must be conducted.

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Introduction

Dental amalgam is generally regarded as an ideal restorative material due to its high

strength, longevity and cost-effectiveness (1). Yet, a common phrase within the dental

community is “if you build it, it will fail.” This is true for dental amalgam restorations, with one

study claiming that replacing restorations occupies 72% of a dental practitioner’s time (2). In

this regard, there is debate amongst dental professionals as to when an amalgam should be

repaired or replaced. Does a cracked isthmus call for complete removal or simply repair? What

about a deficient margin or a restoration that has suffered recurrent decay? These situations are

routinely encountered in dental practices, but are the clinical treatments based on the literature or 

existing dogmas?

According to the literature, the most frequently reported reason for failure of an amalgam

restoration is recurrent or secondary caries (3, 4). The second most frequently reported factor is

fracture, which included isthmus/bulk fracture, marginal fracture and tooth fracture (3-9). Bulk 

fractures were predominant in restorations that had three or four surfaces, whereas marginal gaps

or marginal leakage were more frequent in restorations with one or two surfaces (3). Other 

factors include esthetic concerns, marginal defects, poor anatomy, excessive wear, marginal

discolouration, pain, sensitivity, and colour changes (5, 10).

According to this literature, amalgam repair should be used more often since it is more

conservative, as it removes less tooth structure, and especially with newer amalgam bonding

adhesives that provide a stronger bond between the old and new amalgam (11, 12). Nonetheless,

the literature is conflicted in terms of the success of many of these approaches (11).

In this study, replacement of amalgam was defined as the complete removal of the

existing amalgam restoration and its replacement with another dentin substitute or prosthesis.

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Amalgam repair was defined as the replacement of the defective or fractured aspect of the dental

amalgam restoration with new amalgam.

In turn, this paper is an evidence-based literature review of the replacement or repair of 

failed posterior amalgam restorations in the permanent dentition.

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Methods

Search Strategy

An initial search for relevant academic papers was performed using eleven electronic

databases, which can be seen in Table 1. The MeSH terms used were:

a)  Dental Amalgam OR Dental Restoration Failure AND posterior AND replace* repair*

 NOT implant NOT denture

 b)  Dental Amalgam OR Dental Restoration Failure AND posterior AND repair* NOT

implant NOT denture

Additionally when MeSH was not applicable, four keyword search phrases were used:

a)  Amalgam AND Posterior AND Restor* AND Replace*

 b)  Amalgam AND Posterior AND Restor* AND Repair 

c)  Amalgam AND Posterior AND Restor* AND Remov*

d)  Amalgam AND Posterior AND Restor* AND Fail*

To finalize the literature search, titles of articles were screened based on relevance to the

research question: “when is the replacement or repair of posterior amalgam restorations indicated

in the permanent dentition?” Abstracts were acquired for the accepted titles. They were

screened based on the inclusion/exclusion criteria presented below. Duplicates were removed at

this stage. Subsequently, full articles were also collected and screened based on the

inclusion/exclusion criteria.

To further achieve a comprehensive search, reference lists of accepted articles were

scanned. Dr. A. Jokstad, Faculty of Dentistry, University of Toronto was also consulted for 

additional resources and references.

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 Inclusion Criteria

Articles selected for this report met the following criteria:

1.  English

2.  Available through Local Holdings (University of Toronto Library Resources)

3.  Publication date of January 1964 to present

4.  Human subjects with permanent dentition

 Exclusion Criteria

Articles selected for this report excluded the following criteria:

1.  Personal or expert opinion

2.   In vitro trials

3.  Topic focused solely on the longevity of the amalgam restoration and not of replacement

or repair 

4.  Languages other than English

Validity Instrument 

Abstracts and full text titles were assessed by two independent reviewers using the

inclusion/exclusion criteria. Any discrepancies between the two reviewers were discussed

 between all group members. The validity and quality of the resultant three articles was assessed

using “Checklist to Assess Evidence of Efficacy of Therapy or Prevention” developed by J.L.

Leake (Appendix A). Each article was scored by two independent reviewers and could receive a

maximum score of fifteen. When a discrepancy in the article score of two or more points was

demonstrated, a final score was determined after discussion between all six group members. All

studies receiving a score of 9 or more were retained.

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 Literature Search Results

The literature search resulted in a total yield of 4015 articles. The total number of 

relevant articles yielded after the title stage was 310 (Table 2 provides details). The 310

abstracts were further reduced to 53 based on the inclusion/exclusion criteria. Three articles

were ultimately selected for validity scoring. Upon reviewing reference lists located at the back 

of the accepted articles, no additional articles were accepted. The consultation with Dr. Jokstad

yielded no additional resources and references.

Table 1: Electronic Literature Search of Internet and Academic Sources

Literature Search

Method Sources Total #Hits # Abstractsretrieved

Academic Literature Database Search (accessed through U of T Library Resources)

Pubmed 189 30

Ovid:MEDLINE, CINAHL (Cumulative Index to Nursing & Allied

Health Literature), EMBASE, All Evidence Based Medicine

Reviews (Cochrane Database of Systematic Reviews (CDSR),American College of Physicians (ACP) Journal Club, Database

of Abstracts of Reviews of Effects (DARE), and CCTR 

(formerly Cochrane Controlled Trials Register), Cochrane

Methodology Register (CMR), Health Technology Assessment(HTA), and NHS Economic Evaluation Database (NHSEED).

208 82

Scopus 1483 74

Web of Science 110 44

BIOSIS 24 16

Grey Literature Internet Search 

American Assoc. Operative

Dentistry Guidelineshttp://www.jopdent.org/ 1 0

 National Institutes for Health and

Clinical Evidence (NICE) http://www.nice.org.uk/ 0 0

Google Scholar  http://scholar.google.ca/ 843 27

 National Institute of Dental and

Craniofacial Research (NIDCR)http://www.nidcr.nih.gov/ 44 3

Journal of the Canadian Dental

Association (JCDA)

http://www.cda-adc.ca/jcda/311 7

Journal of American Dental

Association (JADA)http://jada.ada.org/ 802 27

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Table 2: Number of Abstracts selected after rejection at title stage

Search Terms:

      P     u      b     m

    e     d

     O     v      i     d

     A     m

    e     r .      A    s    s    o

    c .      O     p     e

     r    a      t      i     v    e 

      D    e     n      t      i    s      t     r     y  

     G     u      i     d

    e      l      i     n    e    s

      N      I     C

      E

      W    e      b

     o      f      S    c      i    e     n

    c    e

      B      i    o    s      i    s

     G    o    o

    g        l    e 

     S    c      h

    o      l    a     r

      N      I      D

     C      R

      J     C      D

     A

     A      D

     A

     S    c    o     p      u

    s

MeSH: Dental Amalgam or

Dental Restoration Failure

AND posterior AND (replace*

OR repair*) NOT implant

NOT denture

7 17 N/A N/A N/A N/A N/A 3 0 23 N/A

Amalgam AND PosteriorAND Restor* AND

Replace*

10 22 1 0 17 5 8 0 7 4 28

Amalgam AND Posterior

AND Restor* AND Repair1 4 0 0 4 1 4 0 0 0 5

Amalgam AND Posterior

AND Restor* AND

Remov*

0 6 0 0 6 2 8 0 0 0 8

Amalgam AND Posterior

AND Restor* AND Fail*12 33 0 0 17 8 7 0 0 0 33

 

Table 3: Summary of Literature Search Results

YieldAfter Rejecting at

Title Stage

After Rejecting At

Abstract Stage

After Rejecting At

Full Text StageAccepted

4015 310 53 3 2

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Results

Two studies were identified that investigated the effectiveness of alternative treatments

for replacing defective amalgam restorations, one randomized controlled trial (13)  and one

 prospective cohort clinical trial (14).

 Both studies were abstracted into evidence tables

(Appendix 1).

Moncada et al. (13) studied patients treated at the Operative Dentistry Clinic at the

College of Dentistry, Univeridad de Chile. Sixty-six patients with 271 defective amalgam and

composite resin restorations were randomly assigned to five groups: sealant (etch and resin-

 based sealant), refurbish (smooth and polish), repair (removal of restorative material adjacent to

defect and repair with amalgam or resin-based filling), replacement (complete removal of 

defective restoration and complete replacement) and no treatment. Sixty-four of the sixty-six

(97%) patients returned after a 12-month period and were assessed by two independent

examiners; examiners performed calibration exercises at baseline (Kappa 0.74) and upon recall

evaluation (Kappa 0.81). The authors found all treatment groups showed improvements from

 baseline, based on ten clinical characteristics using Ryge USPHS criteria (Table 4). A change

from bravo to alfa was considered an improvement, while a change from alfa to bravo or charlie

indicated deterioration. Most improvements from bravo to alfa were from the sealant group,

representing a 16-fold improvement (p<0.0001). A four-fold (p<0.0001), three-fold (p=0.003)

and two-fold (p<0.0001) increase in alfa rating was observed in the replaced, repaired and

refurbished groups, respectively. The no treatment group was the only one to show a reduced

rating from alfa to either bravo or charlie (p=0.242). The authors concluded that repairing

defective restorations, instead of complete replacement, is an acceptable, economical and

efficient technique causing minimal loss of tooth structure and increasing the longevity of the

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restoration; longevity, however, was not actually measured as the authors only collected data at

the 1-year recall examinations. Moreover, the authors failed to report the results for the resin-

 based and amalgam restorations separately; this study was still included in the report due to the

lack of data on this subject (13).

Table 4: Modified Ryge USPHS clinical criteria.Clinical

Characteristics Alfa Bravo Charlie

Color The restoration matches

in color and translucency

to adjacent tooth structure

The mismatch in color and

translucency is within the

acceptable range of toothcolor and translucency

The mismatch is

outside the acceptable

range of color andtranslucency

Marginal adaptation Explorer does not catch or 

has one-way catch when

drawn across therestoration/tooth interface

Explorer falls into crevice

when drawn across the

restoration/tooth interface

Dentin or base is

exposed along the

margin

Anatomic form The general contour of the

restoration follows the

contour of the tooth

The general contour of the

restoration does not follow

the contour of the tooth

The restoration has an

overhang

Surface roughness The surface of the

restoration has no surface

defects

The surface of the

restoration has minimal

surface defects

The surface of the

restoration has severe

surface defects

Marginal staining There is no discoloration

 between the restoration

and tooth

There is discoloration on

less than half of the

circumferential margin

There is discoloration

on more than half the

circumferential margin

Interfacial staining There is no stain on the

restoration, or the stain isequal on both the tooth

and restoration

There is more stain on the

restoration than on thesurrounding tooth structure

The stain cannot be

 polished off therestoration (body

discoloration)

Contact Normal Light None

Postoperative

sensitivity

 No sensitivity when an air 

syringe is activated for 2

seconds at a distance of 0.5 in. from the

restoration with the facial

surface of the proximal

tooth covered with gauze

Sensitivity is present when

an air syringe is activated

for 2 seconds at a distanceof 0.5 in. from the

restoration with the facial

surface of the proximal

tooth covered with gauze

and ceases when thestimulus is removed

Sensitivity is present

when an air syringe is

activated for 2 secondsat a distance of 0.5 in.

from the restoration

with the facial surface

of the proximal tooth

covered with gauze anddoes cease when the

stimulus is removed

Secondary caries There is no clinical

diagnosis of caries

  N/A There is clinical

diagnosis of cariesLuster of restoration The restoration surface is

shiny and has an enamel-

like, translucent

The restoration surface is

dull and somewhat opaque

The restoration surface

is distinctly dull and

opaque and isesthetically displeasing

Reproduced from: Moncada, GC, Martin, J, Fernandez, E, Vildosola, PG, Caamano, C, Caro, MJ, Mjor, IA, Gordon,

VV. Alternative treatments for resin-based composite and amalgam restorations with marginal defects: A 12-month

clinical trial. General Dentistry 2006;50(5):314-8.

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The second study by Gordan et al. (14) was very similar in methodology and analysis;

however the study type was a prospective cohort clinical trial. Gordan et al. recruited forty-five

 patients with 113 defective amalgam restorations from the Operative Dentistry Clinic, College of 

Dentistry, University of Florida and randomly assigned them to five groups: repair, sealing,

refurbishing, total replacement and no treatment. The aim of this study was to assess the

longevity of defective amalgam restorations treated by repair, sealant or refurbishing, rather than

complete replacement. Contrary to their objective, the authors failed to report any significant

 period of longevity; outcomes after 1-year and 2-year recalls were reported. Loss to follow-up

was 30% and 35% at the 1- and 2-year recall appointments, respectively. Te authors also fail to

mention if the returning patients were the same at both recall exams. Two independent

examiners evaluated the clinical quality of the restorations at baseline and after the assigned

treatment, with inter-examiner agreement ratio of 92%. Similar to Moncada et al., this study

used the Ryge USPHS clinical criteria and alfa, bravo and charlie assignments; however, Gordan

et al. used only eight clinical characteristics for comparisons: 1) occlusal marginal adaptation, 2)

 proximal adaptation, 3) occlusal anatomic form, 4) proximal anatomic form, 5) occlusal contact,

6) proximal contact, 7) secondary caries and 8) post-operative sensitivity (Table 4). All

restorations received a score for each clinical characteristic at baseline and post-treatment, except

for those restorations receiving no treatment. Four outcomes were used to assess the change in

clinical condition at 1- and 2-year recall exams: a grade of 1 signifying an upgrade from bravo to

alfa, 0 as no change, -1 a downgrade from alfa the bravo or bravo to charlie, or –2 a downgrade

from alfa to charlie. The authors reported a statistically significant improvement in “all

alternative groups when compared to the no treatment group for marginal adaptation and

anatomical form characteristics. (14)” The refurbishing and sealant groups showed “statistically

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significant downgrading on marginal adaptation and anatomic form compared to the replacement

group and the repair group at both 1- and 2-year recalls. (14)” Compared to the repair and

replacement groups the no treatment group was significantly more likely to downgrade in

marginal adaptation. The repair group “showed no significantly different outcome when

compared to the replacement group. (14)”  The authors concluded that repair or replacement of 

defective restorations with a bravo rating for marginal adaptation or anatomical form would

result in the most predictable outcomes, and that repairing defective restorations offers the most

conservative treatment (14).

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Discussion

The lack of clinical evidence is apparent in regard to the when to replace or repair 

 posterior amalgam restorations; the majority of the literature pertaining to this topic consists of 

cross-sectional surveys ascertaining the reasons for replacement or repair of posterior amalgams.

Only two relevant studies were retrieved from over 4000 articles found. In addition, the strength

of the two studies is poor. The randomized control trial by Moncada et al., level of evidence I,

failed to report if ethical approval was obtained and moreover, the study failed to differentiate

 between amalgam and composite restorations in their analysis and results. Additional

limitations, which were also common to the prospective cohort study by Gordan et al., level of 

evidence II-B, include: insufficient duration of the studies; failure to report demographics of the

study group and whether participants were treated equally; failure to report the method of 

randomization, the class of restoration being treated and the number of operators providing the

treatment; and failure to control for external dental care. Furthermore, the results are arguably

limited to the specific populations studied, thereby limiting external validity. Ultimately, there is

insufficient evidence to make a recommendation regarding when a posterior amalgam should be

replaced or repaired – a clinical decision that is made by all dentists on a daily basis.

This dilemma in the dentist’s practice prompted Paterson et al. in 1995 (10) to develop

valid criteria for the replacement of amalgam restorations. The first stage of proposals was

developed by a panel of dental academics using a modified Delphi technique which employed

sequential questionnaires in order to aggregate judgments and reach a consensus opinion. The

questionnaires were sent to individual academic dentists and general dental practitioners in

Scotland who were asked to comment on the issues being discussed and to provide reasons for 

their choice.

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The first round of the Delphi questionnaire consisted of nineteen advisory statements on

criteria to be adopted when considering whether or not an amalgam restoration should be

replaced. The panel was asked to comment on the format of the statements and to rate the

 proposals using the modified Turoff scoring system. Each statement was scored for five key

items: importance, confidence, desirability, probability and feasibility.

The panel reached a unanimous agreement that lost amalgam restorations should be

replaced and amalgams that were fractured required replacement/repair. They also agreed that

ditching at the margins was not an indication for the replacement or repair of the amalgam

restoration. It was also concluded that amalgam restorations should be locally repaired rather 

than totally replaced. Consensus was also reached regarding the need to modify defective

contact areas in Class II restorations. They also felt that replacement of amalgam due to allergy

should only occur after specialist testing and advice. Finally, the panel concurred that before a

decision to replace/repair could be made, an assessment of the patient’s caries risk and

consideration of the individual restoration must occur. A consensus view, however, could not

 be reached regarding policy statements relating to pain management, white spots adjacent to

restoration margins and dentinal staining of existing amalgam restorations. A reproduction of the

criteria is included in Appendix C. The next stage in the development of the criteria is to send

these statements to a panel of general dental practitioners to obtain their consensus view, again

using the Delphi technique.

To further the research on this topic, future studies addressing this clinical question will

require improved design methods. According to Hickel et al.’s 2007 review on conducting

controlled clinical trials (15), an ideal restorative study is a randomized control trial with proper 

randomization and concealment of allocation. Split mouth design or a paired tooth design is

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optimal although not always practical. Alternatively, a prospective cohort clinical trial is

comparable study design but is considered second in the level of evidence ranking. Blinding in

in vivo studies where there are two independent assessors is impossible due to the nature of 

restoration evaluation. The sample should be a good representation of the healthy population

and the sample size should have adequate statistical power. Fully standardized procedures

should be preset with regards to who will do the dental procedure, the technique and materials

used, and who will assess the restoration. It is recommended that calibration training and inter-

examiner agreement be at the ≥ 85% level to ensure a reproducible restoration assessment. The

analysis should account for the class of restoration because the dimension and size of the

restoration may have an effect to the outcome.

To adequately address whether clinicians should replace or repair posterior amalgams,

only two intervention groups should be present as direct comparators: replacement or repair of 

amalgam restoration with amalgam. Including an untreated control group may be considered

unethical where the standard of care is to provide some form of treatment. The restorations need

to be validly and reliably measured. The Ryge Criteria is considered standard outcome measure

for restorations; however, with the advent of new dental materials, more sensitive assessment or 

scoring methods need to be used. Hickel et al. refers to a two-step method of scoring where the

first step evaluates clinical acceptability of the restoration based on the Ryge classification:

Table 5: Overview of Ryge Criteria

Ryge Classification Score Restoration is:

1 Excellent, fulfilling all quality criteria; tooth and/or surroundingtissues are adequately protected

Alpha

2 Highly acceptable, though one or more criteria is not ideal; minor 

modifications can be made to the restoration but is not necessary

Bravo 3 Sufficiently acceptable but with minor shortcomings in areas

where any instrumentation may result in damage to the tooth; no

adverse effects are anticipated

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Charlie 4 Unacceptable but repairable

Delta 5 Unacceptable and must be replaced

A Modified Ryge USPHS Criteria (Table 4) has been developed and used in the studies found in

our literature search. The second step is the classification of the restoration into aesthetic,

functional and biological categories (Appendix D). For direct restorations, there is a

recommendation for a three-year observation period involving four recall appointments: baseline

at one-week (maximum one month) post-insertion, and yearly recalls at 12, 24, and 36 months.

Still, follow-up times of longer duration such as for 7-10 years would be more appropriate.

Studies have shown that repair and replace treatments have equivalent longevity after 5 years

while repaired restorations show a lower survival rate compared to replaced restorations after 10

years (15).

Until more research and guidelines are developed, the clinician must consider several

factors prior to deciding when to replace or repair posterior amalgam restorations. The majority

of factors that affect a clinician’s decision is centered around the patient. The dentist must

access and account for the patient’s caries risk, any present or future periodontal conditions, the

size and location of the restoration, the medical history of the patient, in particular, manual

dexterity, and their economic situation. The last factor could potentially be the most significant

factor as whether to repair or replace the restoration. After assessment of the restoration, the

determination of restoration prognosis and the presentation of treatment options to the patient,

the dentist will ultimately perform the preferred treatment of the patient. In the case where the

 patient chooses the less expensive treatment of lower prognosis, the dentist will respect the

 patient’s decision. This clinical reality makes incorporation of evidence-based care difficult in

instances where finances play a major role in the provision of treatment.

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Conclusion

The evidence-based literature on whether to replace or repair posterior amalgam

restorations in the permanent dentition is scarce and of poor quality. Future studies should be

carried out using the suggested improvements discussed in the paper, including statistically

significant sample size and a high level design study such as a randomly controlled trial or 

 prospective cohort. Due to the lack of good clinical evidence, we are unable to make an

evidence-based recommendation as to when to replace or repair defective posterior amalgam

restorations in the permanent dentition.

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Appendix A:

Checklist to Assess Evidence of Efficacy of Therapy or Prevention

Citation: 

1. Was the study ethical? ___ 

2. Was a strong design used to assess efficacy? ___ 

3. Were outcomes (benefits and harms) validly and reliably measured? ___ 

4. Were interventions validly and reliably measured? ___ 

5. What were the results?

Was the treatment effect large enough to be clinically important? ___ 

Was the estimate of the treatment effect beyond chance and relatively precise? ___ If the findings were “no difference” was the power of the study 80% or better ___ 6. Are the results of the study valid?

•  Was the assignment of patients to treatments randomised? ___ 

•  Were all patients who entered the trial properly accounted for and attributed at its conclusion?

i) Was loss to follow-up less than 20% and balanced between test and controls ___ 

ii) Were patients analysed in the groups to which they were randomised? ___ 

•  Was the study of sufficient duration? ___ 

•  Were patients, health workers, and study personnel “blind” to treatment? ___ 

•  Were the groups similar at the start of the trial? ___ 

•  Aside from the experimental intervention, were the groups treated equally? ___ 

•  Was care received outside the study identified and controlled for ___ 

7. Will the results help in caring for your patients?

Were all clinically important outcomes considered? ___ 

Are the likely benefits of treatment worth the potential harms and costs? ___ 

SCORE OUT OF 17 - ___N/A:

Please note for our purposes, “no difference” and “blinding” statements did not apply. Thus, the

score was taken over a denominator of 15.

Adapted from: Fletcher, Fletcher and Wagner. Clinical epidemiology – the essentials. 3rd

ed.

1996, and Sackett et al. Evidence-based medicine: how to practice and teach

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Appendix C: Paterson FM et al. Criteria

Initial propositions on repair/replacement of amalgam agreed by academic group

Table reproduced from: Paterson, FM, Paterson, RC, Watts, A, and Blinkhorn, AS. Initial stages

in the development of valid criteria for the replacement of amalgam restorations.  Journal of 

 Dentistry 1995;23(9): 137-143.

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Appendix D: Hickel R et al.’s Criteria to evaluate restorations

Allocation of criteria to clinical observations

Table reproduced from: Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson

V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlledclinical studies of dental restorative materials. Clinical Oral Investigation 2007; 11: 5-33

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Acknowledgements

We would like to thank Dr. Carlos Quiñonez and Dr. James Leake of the Department of 

Community Dentistry, Dr. Asbjørn Jokstad of Department of Prosthodontics, and Dr. Dena

Taylor of the Health Sciences Writing Centre, University of Toronto for their guidance and

expertise.

This evidence-based report was conducted as an academic requirement of DEN207Y

Community Dentistry.

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