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Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DOI: 10.1002/14651858.CD005970.pub2 This review should be cited as: Sharif Mohammad O, Merry Alison, Catleugh Melanie, Tickle Martin, Brunton Paul, Dunne Stephen M, Aggarwal Vishal R. Replacement versus repair of defective restorations in adults: amalgam. Cochrane Database of Systematic Reviews. In: The Cochrane Library, Issue 11, Art. No. CD005970. DOI: 10.1002/14651858.CD005970.pub2 ABSTRACT
Background Amalgam is a common filling material for posterior teeth, as with any restoration amalgams have a finite life-span. Traditionally replacement was the ideal approach to treat defective amalgam restorations, however, repair offers an alternative more conservative approach where restorations are only partially defective. Repairing a restoration has the potential of taking less time and may sometimes be performed without the use of local anaesthesia hence it may be less distressing for a patient when compared with replacement. Objective To evaluate the effectiveness of replacement (with amalgam) versus repair (with amalgam) in the management of defective amalgam dental restorations in permanent molar and premolar teeth. Criteria for considering studies for this review For the identification of studies relevant to this review we searched the Cochrane Oral Health Group Trials Register (to 23rd September 2009); CENTRAL (The Cochrane Library 2009, Issue 4); MEDLINE (1950 to 23rd September 2009); EMBASE (1980 to 23rd September 2009); ISI Web of Science (SCIE, SSCI) (1981 to 22nd December 2009); ISI Web of Science Conference Proceedings (1990 to 22nd December 2009); BIOSIS (1985 to 22nd December 2009); and OpenSIGLE (1980 to 2005). Researchers, experts and organisations known to be involved in this field were contacted in order to trace unpublished or ongoing studies. There were no language limitations. Selection criteria Trials were selected if they met the following criteria: randomised or quasi-randomised controlled trial, involving replacement and repair of amalgam restorations. Data collection and analysis Two review authors independently assessed titles and abstracts for each article identified by the searches in order to decide whether the article was likely to be relevant. Full papers were obtained for relevant articles and both review authors studied these. The Cochrane Collaboration statistical guidelines were to be followed for data synthesis. Main results The search strategy retrieved 145 potentially eligible studies, after de-duplication and examination of the titles and abstracts all but three studies were deemed irrelevant. After further analysis of the full texts of the three studies identified, none of the retrieved studies met the inclusion criteria and all were excluded from this review. Authors' conclusions There are no published randomised controlled clinical trials relevant to this review question. There is therefore a need for methodologically sound randomised controlled clinical trials that are reported according to the Consolidated
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Standards of Reporting Trials (CONSORT) statement (www.consort-statement.org/). Further research also needs to explore qualitatively the views of patients on repairing versus replacement and investigate themes around pain, distress and anxiety, time and costs.
BACKGROUND
The treatment of dental caries is a major focus of clinical dentistry. Amalgam is a commonly used filling material but amalgam restorations have a finite life-span. Replacement has traditionally been seen as the ideal approach to the treatment of defective amalgam restorations and may be the only option where a defect is extensive. However, repair offers an alternative more conservative approach where a restoration is only partially defective ( Wilson 1999 ). Replacement restorations make up a major part of the dental treatment provided in Europe and the USA ( Burke 1999 ; DPB 2003 ; Setcos 2004 ) and place a high financial burden on dental health services ( Paterson 1995 ). The decisions leading to the placement, replacement or repair of restorations are central to clinical dental practice but appear to be based on local practice patterns and individual clinical experience rather than evidence of effectiveness ( Burke 1999 ; Deligeorgi 2000 ; Drake 1990 ; Elderton 1990 ). Replacement involves the complete removal of old amalgam together with base or lining materials and carries a risk of the inadvertent removal of sound tooth tissue. Repeated replacement is therefore associated with a progressive increase in cavity size ( Mjor 1998 ). In addition, each time dentine is cut during cavity preparation there is a risk of damage to the dental pulp and the development of clinical symptoms ( Wilson 1999 ). Although the commonest reason for the replacement of a filling is the diagnosis of secondary caries ( Burke 1999 ; Mjor 1992 ; Mjor 2000 ; Mjor 2002a ; Setcos 2004 ), the definition of this is ill-defined and lesions diagnosed as secondary caries may encompass both non-carious defects and small areas of secondary caries which are amenable to repair ( Mjor 2002b ). The belief that microleakage of oral fluids into marginal or interfacial defects leads to secondary caries or pulpal pathology underpinned the traditional support for replacement over repair. However, although microleakage may be observed under laboratory conditions, it does not necessarily occur in the clinical situation ( Wilson 1999 ). In the repair of a defective amalgam restoration only the defective area is removed and replaced. Repair offers a pragmatic approach and has a number of potential advantages - it is more conservative, quicker, cheaper, less traumatic to the patient and the tooth, and local anaesthesia may not be required ( Mjor 1993 ). Funding systems may influence dentists' decisions about whether to replace or repair restorations ( Burke 2002 ). For example, 'fee for item of service' systems may favour replacement whereas capitation-based systems are more likely to encourage repair. Dentists' decisions on whether to replace or repair may also be influenced by teaching which has traditionally advocated replacement as the treatment of choice ( Wilson 1999 ) and a lack of knowledge about repair techniques ( Cook 1981 ). This review aims to evaluate the effectiveness of replacement (with amalgam) versus repair (with amalgam) for defective amalgam dental restorations in permanent molar and premolar teeth.
OBJECTIVES
To evaluate the effectiveness of replacement (with amalgam) versus repair (with amalgam) in the management of defective amalgam dental restorations in permanent molar and premolar teeth. The following null hypothesis was tested: There is no difference in the effectiveness of replacement (with amalgam) of defective amalgam dental restorations compared to the repair (with amalgam) of defective amalgam dental restorations in permanent molar and premolar teeth.
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METHODS OF THE REVIEW CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW Types of studies
Randomised controlled trials (RCTs) and quasi-randomised controlled trials including split-mouth studies.
Types of participants
Adults (16 years or over) with one or more defective amalgam restoration(s) in a molar or premolar tooth/teeth treated by like for like replacement (i.e. replacement with amalgam) and/or like for like repair (i.e. repair with amalgam). Participants in whom a tooth undergoes further restoration or an extraction for reasons not connected with the repair/replacement restoration (e.g. extraction due to periodontal disease) were not included.
Types of intervention
Studies with the following interventions and controls were included: Intervention: repair of a defective amalgam restoration in a permanent molar or premolar tooth with amalgam. Control: replacement of a defective amalgam restoration in a permanent molar or premolar tooth with amalgam. In the context of this systematic review, the terms 'repair' and 'replacement' are defined as follows. A repair to an amalgam restoration is defined as the removal of only the defective part of a restoration and/or adjacent tooth tissue and followed by the placement of a new 'partial' restoration. A replacement amalgam restoration is defined as the removal of an entire restoration including any bases, liners, secondary caries and tooth tissue where appropriate, followed by the placement of a new restoration. This systematic review was not concerned with studies involving the refurbishment of amalgam restorations. In order to ensure that there is clarity regarding the inclusion and exclusion criteria, refurbishment is defined for the purposes of this review as the reshaping, refinishing or removal of overhangs in an existing restoration which does not require the placement of additional restorative material. In order to be included in this review, studies must have used clearly defined criteria for assessing whether restorations were defective. Studies were expected to use the same criteria at baseline and follow-up stages. Although criteria for standardising the diagnosis of defective restorations are not well defined or universally accepted, the US Public Health Service (USPHS) criteria and modified Ryge criteria provide possible models for this ( Ryge 1981 ).
Secondary outcomes
In addition to the main outcome measure, any outcomes reported perioperatively (e.g. pain/discomfort) and postoperatively (i.e. within 48 hours; e.g. pain/discomfort) were to be recorded. Where any other outcomes were presented e.g. related to patient experience or aesthetics these were also to be recorded.
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Language
The search attempted to identify all relevant studies irrespective of language. Any non-English papers identified were to be translated and relevant data extracted by members of The Cochrane Collaboration.
Unpublished studies
Researchers, experts and organisations known to be involved in this field were contacted in order to trace unpublished or ongoing studies. In addition, conference proceedings and abstracts were searched for unpublished studies.
Handsearching
No handsearching was carried out for this review. All relevant journals had either been handsearched as part of the Cochrane Oral Health Group's handsearching programme (see www.ohg.cochrane.org/handsearching.html for information) or were fully indexed on MEDLINE and retrieved as part of the electronic searches. Reference lists of all eligible trials and review articles, and in turn their reference lists, were checked for studies not already identified.
DATA COLLECTION AND ANALYSIS Data collection and analysis Selection of studies
Two review authors, Mohammad Owaise Sharif (MOS) and Vishal Aggarwal (VA), independently assessed the abstracts of studies resulting from the searches. Full text copies of all relevant and potentially relevant studies, those appearing to meet the inclusion criteria, or for which there were insufficient data in the title and abstract to make a clear decision, were obtained. The full text papers were assessed independently by these two review authors and any disagreement on the eligibility of potentially included studies were resolved through discussion and consensus. If consensus could not be reached by the two review authors (MOS and VA), a third review author (Martin Tickle (MT)) was consulted. After assessment by the review authors, any duplicate publications or remaining studies that did not match the inclusion criteria were excluded and the reasons for their exclusion noted. In this review, we did not find any eligible study to be included. If any studies were eligible, the following steps were to be taken.
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intervention, treatments, controls, outcomes; sample size, number recruited, details of withdrawals by study group, age and characteristics of subjects; outcomes, assessment methods and time intervals; study setting and source of funding. If necessary, authors were to be contacted for further information and/or clarification of their publications.
Assessment of heterogeneity
Heterogeneity was to be assessed by examination of the types of participant, intervention and outcome measure in each study. The significance of discrepancies in the estimates of the treatment effects from the different trials would have been assessed by means of Cochran's test for heterogeneity. Heterogeneity would have been investigated if P < 0.01. Heterogeneity would have been quantified using the I2 statistic.
Adverse effects
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Any unexpected or adverse events/outcomes were to be documented if identified in included randomised controlled trials.
Sensitivity analysis
Sensitivity analysis would have been undertaken to assess the effects of randomisation, allocation concealment and blinding on the overall estimates of effect.
Subgroup analyses
Subgroup analyses would have been undertaken to take account of the use of different inclusion criteria, participants, interventions, techniques, materials, or outcome measures if appropriate.
Effects of interventions
Although 145 studies were retrieved in our comprehensive search of the literature, none of them were eligible for inclusion for the reasons stated, and therefore no data were available for analysis.
DISCUSSION Discussion
The present review sought high level evidence on the effectiveness of managing defective amalgam restorations in permanent molar and premolar teeth by replacing (with amalgam) compared with repairing (with amalgam). We found no studies eligible for inclusion in this review. The two randomised trials retrieved, Moncada 2008 and Moncada 2006 , reported on the same set of patients at
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different follow-up periods. The sample size has not been justified, the method of randomisation was not stated, the results regarding the deterioration of repaired restorations were not reported in a manner to allow differentiation between the repair materials used and so the results were unusable. No mention of allocation concealment, blinding of patient, outcome assessor blinding or reasons for patient withdrawal were given. The authors were contacted for further information and only advised that outcome assessors were blinded. The results from the articles retrieved suggest that repair of restorations could be effective and the survival rate at 2-year follow-up is good. This may be important because some repairs can be done without the use of local anaesthesia and are therefore less distressing for a patient when compared with replacement.
ACKNOWLEDGEMENTS Acknowledgements
Dr Anne-Marie Glenny, Mrs Sylvia Bickley, Miss Anne Littlewood and Mrs Luisa M Fernandez Mauleffinch.
NOTES REFERENCES
* indicates the major publication for the study References to studies excluded from this review Moncada 2006 {published data only} Moncada GC, Martin J, Fernandez E, Vildosola PG, Caamano C, Caro MJ. Alternative treatments for resin-based composite and amalgam restorations with marginal defects: a 12-month clinical trial. General Dentistry 2006;54:314-8. Moncada 2008 {published data only} Moncada G, Fernandez E, Martin J, Arancibia C, Mjor IA, Gordan VV. Increasing the longevity of restorations by minimal intervention: a two-year clinical trial. Operative Dentistry 2008;33:258-64. Moncada 2009 {published data only} Moncada G, Martin J, Fernandez E, Hempel MC, Mjor IA, Gordan VV. Sealing, refurbishment and repair of Class I and Class II defective restorations: a three-year clinical trial. Journal of the American Dental Association 2009;140:425-32. Additional references Burke 1999
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Burke FJ, Cheung SW, Mjor IA, Wilson NH. Reasons for the placement and replacement of restorations in vocational training practices. Primary Dental Care 1999;6:17-20. Burke 2002 Burke FJ, Wilson NH, Cheung SW, Mjor IA. Influence of the method of funding on the age of failed restorations in general dental practice in the UK. British Dental Journal 2002;192:699-702. Cook 1981 Cook AH. Amalgam addition restorations. Dental Update 1981;8:457-63. Deligeorgi 2000 Deligeorgi V, Wilson NH, Fouzas D, Kouklaki E, Burke FJ, Mjor IA. Reasons for placement and replacement of restorations in student clinics in Manchester and Athens. European Journal of Dental Education 2000;4:153-9. DPB 2003 Dental Practice Board. GDS treatment items by country and broad age group. Detailed analyses for the year ending March 2003. :-. Drake 1990 Drake CW, Maryniuk GA, Bentley C. Reasons for restoration replacement: differences in practice patterns. Quintessence International 1990;21:125-30. Elderton 1990 Elderton RJ. Clinical studies concerning re-restoration of teeth. Advances in Dental Research 1990;4:4-9. Higgins 2009 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions 5.0.2 [updated September 2009]. The Cochrane Collaboration, 2009. :-. Mjor 1992 Mjor IA, Toffenetti F. Placement and replacement of amalgam restorations in Italy. Operative Dentistry 1992;17:70-3. Mjor 1993 Mjor IA. Repair versus replacement of failed restorations. International Dental Journal 1993;43:466-72. Mjor 1998 Mjor IA, Reep RL, Kubilis PS, Mondragon BE. Change in size of replaced amalgam restorations: a methodological study. Operative Dentistry 1998;23:272-7. Mjor 2000 Mjor IA, Moorhead JE, Dahl JE. Reasons for replacement of restorations in permanent teeth in general dental practice. International Dental Journal 2000;50:361-6. Mjor 2002a Mjor IA, Shen C, Eliasson ST, Richter S. Placement and replacement of restorations in general dental practice in Iceland. Operative Dentistry 2002;27:117-23. Mjor 2002b Mjor IA, Gordan VV. Failure, repair, refurbishing and longevity of restorations. Operative Dentistry 2002;27:528-34. Paterson 1995 Paterson FM, Paterson RC, Watts A, Blinkhorn AS. Initial stages in the development of valid criteria for the replacement of amalgam restorations. Journal of Dentistry 1995;23:137-43. Ryge 1981 Ryge G, Jendresen MD, Glantz PO, Mjor I. Standardization of clinical investigators for studies of
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restorative materials. Swedish Dental Journal 1981;5:235-9. Setcos 2004 Setcos JC, Khosravi R, Wilson NH, Shen C, Yang M, Mjor IA. Repair or replacement of amalgam restorations: decisions at a USA and a UK dental school. Operative Dentistry 2004;29:392-7. Wilson 1999 Wilson NHF, Setcos JC, Brunton P. Replacement or repair of dental restorations. In: Roulet JF, Wilson NHF, Fuzzi M, editor(s). Advances in Operative Dentistry: Contemporary Clinical Practice Vol. 1, Quintessence, 1999:105-15.
COVER SHEET
Replacement versus repair of defective restorations in adults: amalgam Reviewer(s) Sharif Mohammad O, Merry Alison, Catleugh Melanie, Tickle Martin, Brunton Paul, Dunne Stephen M, Aggarwal Vishal R
Contribution of Reviewer(s) Issue protocol first published Issue review first published Date of last minor amendment Date of last substantive amendment Most recent changes Date new studies sought but none found Date new studies found but not yet included/excluded Date new studies found and included/excluded Date reviewers' conclusions section amended Contact address Information not supplied by reviewer 2006 issue 2 2010 issue 2 Information not supplied by reviewer Information not supplied by reviewer
Brunton Clarendon Way Higher Cambridge Street Ruckhall Lane Belmont Walshaw House Regent Street Higher Cambridge Street Denmark Hill Campus Caldecot Road Leeds Manchester Hereford Nelson Manchester London
UK UK
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UK UK UK UK LS2 9LU M15 6FH HR2 9RP BB9 8AS M15 6FH SE5 9RW Telephone: Facsimile: E-mail: p.a.brunton@leeds.ac.uk Cochrane Library number Editorial group Editorial group code CD005970 Cochrane Oral Health Group HM-ORAL
KEYWORDS Adult; Humans; *Dental Restoration Failure ; Dental Amalgam [*therapeutic use] ; Dental Restoration, Permanent [*methods] ; Retreatment [methods] HISTORY History Protocol first published: Issue 2, 2006 Review first published: Issue 2, 2010
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