Sustitución versus reparación de restauraciones defectuosas en adultos: resina compuesta
Resumen
Antecedentes
En los últimos años ha aumentado el uso de materiales de obturación compuestos (o composite) para la restauración de los dientes posteriores como una alternativa para obtener un color de diente diferente al de la amalgama. Como cualquier material de obturación, los composites tienen una duración limitada. Tradicionalmente, la sustitución fue el método ideal para tratar las restauraciones con composites defectuosas; sin embargo, la reparación del composite ofrece un enfoque alternativo y más conservador cuando las restauraciones son todavía utilizables. La reparación de la restauración puede llevar menos tiempo y a veces se puede realizar sin utilizar anestesia local, por lo que puede ser menos angustiosa para el paciente en comparación con la sustitución.
Objetivos
Evaluar la efectividad de la sustitución (con resina compuesta) versus la reparación (con resina compuesta) en el tratamiento de las restauraciones dentales con resina compuesta defectuosas en dientes molares y premolares permanentes.
Métodos de búsqueda
Para la identificación de los estudios relevantes para esta revisión se realizaron búsquedas en el Registro de ensayos del Grupo Cochrane de Salud oral (Cochrane Oral Health Group) (hasta el 24 de julio de 2013); en el Registro Cochrane central de ensayos controlados (Cochrane Central Register of Controlled Trials; CENTRAL) (La Biblioteca Cochrane 2013, número 6); en MEDLINE a través de OVID (1946 hasta el 24 de julio de 2013); en EMBASE a través de OVID (1980 hasta el 24 de julio de 2013); en BIOSIS a través de Web of Knowledge (1969 hasta el 24 de julio de 2013); en Web of Science (1945 hasta el 24 de julio de 2013); y en OpenGrey (hasta el 24 de julio de 2013). Se estableció contacto con investigadores, expertos y organizaciones que se sabe que están involucrados en este campo para rastrear estudios no publicados o en curso. No se impusieron restricciones de idioma ni de fecha de publicación en la búsqueda en las bases de datos electrónicas.
Criterios de selección
Se seleccionaron los ensayos que cumplían los siguientes criterios: ensayo controlado aleatorizado (incluidos los estudios de boca dividida), que incluían la sustitución y reparación de restauraciones con resina compuesta en adultos con una restauración molar defectuosa en un molar o en un premolar permanente.
Obtención y análisis de los datos
Dos autores de la revisión evaluaron de forma independiente los títulos y los resúmenes de cada artículo identificado en las búsquedas, para decidir si el artículo podía ser relevante. Se obtuvieron los documentos completos de los artículos relevantes y ambos autores de la revisión los estudiaron. Se siguieron las guías estadísticas de la Colaboración Cochrane para la síntesis de los datos.
Resultados principales
La estrategia de búsqueda identificó 298 estudios potencialmente elegibles después de la eliminación de los duplicados. Tras el examen de los títulos y los resúmenes, se recuperaron los textos completos de los estudios potencialmente relevantes, pero ninguno de los estudios identificados cumplió los criterios de inclusión de la revisión.
Conclusiones de los autores
No se obtuvieron ensayos controlados aleatorizados publicados que fueran relevantes para la pregunta de esta revisión. Por lo tanto, se necesitan ensayos controlados aleatorizados metodológicamente sólidos que se informen según la declaración Consolidated Standards of Reporting Trials (CONSORT) (www.consort-statement.org/). Los estudios de investigación adicionales también necesitan explorar cualitativamente las opiniones de los pacientes sobre la reparación versus la sustitución e investigar los temas relacionados con el dolor, la ansiedad y la angustia, el tiempo y los costes.
Resumen en términos sencillos
Empastes no metálicos del color del diente: ¿es mejor reparar o sustituir los empastes no metálicos defectuosos en los adultos?
Pregunta de la revisión
¿En los adultos es más efectiva la reparación o la sustitución de los empastes del color del diente (resina compuesta) defectuosos en los dientes molares de la parte posterior de la boca?
Antecedentes
Los empastes se utilizan como parte del tratamiento dental general para reconstruir los dientes después que el paciente desarrolla caries o se daña la superficie del diente de alguna manera.
Los empastes también ayudan a prevenir los daños adicionales (que pueden ser causados por la caries dental adicional debajo el empaste o por el impacto), pero se debe realizar un mantenimiento para garantizar que sigan protegiendo lo que queda del diente original.
Los materiales de empaste del color del diente se han utilizado cada vez más en muchos países como una alternativa a los empastes metálicos o de amalgama más tradicionales. Como cualquier material de empaste, estos tienen una duración limitada y con el tiempo ocurren problemas cuando se rompen o se estropean.
Tradicionalmente se han sustituido los empastes defectuosos, pero este método puede implicar la pérdida de más trozos de diente al vaciar la cavidad y volver a empastarla.
Un enfoque alternativo es reparar el empaste defectuoso. La reparación de los empastes puede tomar menos tiempo, y como algunas reparaciones se pueden realizar sin la necesidad de adormecer el área (anestesia local), la reparación puede ser menos angustiante para el paciente en comparación con la opción de sustituir el empaste. Aspectos como el dolor, la ansiedad, la angustia, el tiempo y el coste son consideraciones importantes para los dentistas y los pacientes.
Esta revisión pretende comparar si es mejor sustituir o reparar los empastes de resina compuesta. La evidencia sobre la reparación o la sustitución de los empastes de amalgama se incluye en otra revisión.
Características de los estudios
Esta revisión de los estudios existentes fue realizada por el Grupo Cochrane de Salud oral, y la evidencia está actualizada hasta el 24 de julio de 2013.
Resultados clave
No se encontraron ensayos adecuados para su inclusión en esta revisión.
Calidad de la evidencia
Actualmente no existe evidencia que apoye la reparación o la sustitución de los empastes de resina compuesta en los adultos.
Se necesitan más estudios de investigación bien realizados antes de poder realizar recomendaciones basadas en la evidencia.
Authors' conclusions
Summary of findings
| Repair compared with replacement of defective resin composite restorations in adults | |
| Patient or population: Adults with defective resin composite restorations in a molar or premolar tooth/teeth Settings: All dental settings Intervention: Repair of defective resin composite restoration (with resin composite) Comparison: Replacement of defective resin composite restoration (with resin composite) | |
| Outcomes | Comments |
| Success or failure of restoration, using a defined criteria | No randomised controlled trials were found |
| Further restoration required | |
| Presence of clinical symptoms (pain, swelling, diagnosis of pulpitis, abscess formation) | |
| Extraction of tooth (due to decay) | |
| Perioperative or postoperative pain or discomfort | |
| Patient satisfaction as measured by patient satisfaction or aesthetic scales | |
| Adverse events | |
| GRADE Working Group grades of evidence | |
Background
Description of the condition
The treatment of dental caries is currently a major focus of clinical dentistry. Although dental amalgam is a widely used material for the restoration of carious posterior teeth in many countries, in those countries where data are available such as the United States of America (USA), Australia, Scandinavia, and the United Kingdom (UK), its use has been found to be decreasing (Burke 2004). This is thought to have been due to concerns relating to its lack of adhesive properties, aesthetics and potential health effects (Lindberg 2005; Roulet 1997). Composite materials have been increasingly used for the restoration of posterior teeth over the last 30 years as a tooth‐coloured alternative to amalgam (Roulet 1997; Sarrett 2005). These may be placed using either direct or indirect techniques (Roulet 1997).
Early composite restorations in posterior teeth were more likely to fail when compared with amalgam restorations (Sarrett 2005). This was due to shrinkage, rapid loss of anatomic form, poor wear and poor colour stability. They also lacked stiffness and adhesion to tooth structure (Lindberg 2005; Roulet 1997; Sarrett 2005). More recently improved resin composites, techniques and instruments have been developed to address these limitations (Sarrett 2005). A systematic review, published in 1999, examined literature on the longevity of routine dental restorations in permanent teeth. This found the most frequently reported median survival time (between six to 10 years) of resin composite restorations was comparable with that for amalgam restorations (Downer 1999). Notwithstanding the improvements in resin composite materials, they still present a number of disadvantages (Lindberg 2005). Another review of a wide methodological range of studies of clinical survival of restorations in permanent posterior teeth, mostly published since 1990, identified the principal reasons for failure of restorations placed using contemporaneously available direct resin composites. These were marginal opening with secondary caries, fracture, marginal deterioration, discolouration and wear (Manhart 2004). Failure of composite restorations is often determined using one of a number of scales which identify quality criteria that relate to clinical acceptability (Lindberg 2005; Ryge 1980; Sarrett 2005). A composite restoration may be considered defective as a result of secondary caries, chipping or fracture of the restoration, chipping or fracture of the tooth or alternatively the presence of a marginal defect/s, i.e. a gap/s between the restoration and the tooth surface.
Description of the intervention
A traditional approach to the management of restorations which fail to satisfy strict quality criteria has been one of replacement (Wilson 1999). Where frank failure of a restoration has occurred there are few alternatives to this approach (Wilson 1999). However, when a restoration is considered to be clinically unacceptable and not suitable for refurbishment, but in part is still serviceable, it may be suitable for repair (Sarrett 2005).
For the repair of a defective composite resin restoration, only the defective area is removed and replaced.This comparatively more conservative approach to the management of defective restorations, when suitable, has the potential to be less costly in terms of time and financial resources, less traumatic for patients, obviate the need for the use of local anaesthesia and be more conservative of tooth tissue (Frankenberger 2003; Mjör 1993; Wilson 1999).
Why it is important to do this review
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 aimed to evaluate the effects of replacement (with resin composite) compared with repair (with resin composite) of defective resin composite dental restorations in permanent molar and premolar teeth.
Objectives
To evaluate the effects of replacement (with resin composite ) versus repair (with resin composite) in the management of defective resin composite dental restorations in permanent molar and premolar teeth.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs), including split‐mouth studies.
Types of participants
Adults (16 years or over) with one or more defective resin composite restoration(s) in a molar or premolar tooth/teeth treated by like‐for‐like replacement (i.e. replacement with resin composite) or like‐for‐like repair (i.e. repair with resin composite) or both. 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.
A composite restoration may be considered defective as a result of secondary caries, chipping or fracture of the restoration, chipping or fracture of the tooth or alternatively the presence of a marginal defect/s, i.e. gap/s between the restoration and the tooth surface.
Types of interventions
Studies with the following interventions and controls were included.
Intervention
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Repair of a defective resin composite restoration in a permanent molar or premolar tooth with resin composite.
Control
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Replacement of a defective resin composite restoration in a permanent molar or premolar tooth with resin composite.
In the context of this systematic review, the terms 'repair' and 'replacement' are defined as follows. A repair to a resin composite restoration is defined as the removal of only the defective part of the restoration or adjacent tooth tissue or both followed by the placement of a new partial restoration. A replacement resin composite restoration is defined as the removal of an entire restoration including any bases, liners and 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 resin composite restorations. In order to ensure that there is clarity regarding the inclusion and exclusion criteria, refurbishment of a resin composite restoration is defined as reshaping or 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 models for this (Ryge 1981).
Types of outcome measures
The main outcome of interest was success or failure of the replacement or repair restoration and associated tooth as assessed by clinical examination. The primary outcome measures were therefore the clinical acceptability or unacceptability of each restoration, defined by the USPHS criteria, Ryge criteria or modifications of these scales, and assessed by clinical examination. It was anticipated that this would be recorded as success or failure of the restoration and/or that further repair or replacement of the restoration was necessary.
Primary outcomes
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Success or failure of restoration, as defined by the USPHS criteria. If this was not reported using the USPHS criteria, information from other measures such as the Ryge criteria or other modifications of these scales and assessment by clinical examination would be used.
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Further restoration (repair, restoration, placement of crown inlay; root filling) required (studies should have determined success or failure according to the same criteria used in the decision to replace or repair the restoration).
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Presence of clinical symptoms (pain, swelling, diagnosis of pulpitis, abscess formation).
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Extraction of tooth due to decay.
Secondary outcomes
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Pain or discomfort associated with the procedure (perioperative or postoperative (i.e. within 48 hours)).
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Patient satisfaction as measured by patient satisfaction or aesthetic scales.
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Adverse effects.
Timing of outcome assessment
Outcome data from all periods of follow‐up were to be included, but where the period of follow‐up differed between studies, this was to be categorised as medium term (less than five years) or long term (five years and above). Time‐to‐event (survival data) was to be collected and analysed where available.
Search methods for identification of studies
Electronic searches
For the identification of studies included or considered for this review, detailed search strategies were developed for each database searched. These were based on the search strategy developed for MEDLINE via OVID (Appendix 1) but revised appropriately for each database to take account of differences in controlled vocabulary and syntax rules.
The following databases were searched.
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The Cochrane Oral Health Group's Trials Register (to 24 July 2013) (Appendix 2);
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The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 6) (Appendix 3);
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MEDLINE (1946 to 24 July 2013) (Appendix 1);
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EMBASE (1980 to 24 July 2013) (Appendix 4);
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BIOSIS via Web of Knowledge (1969 to 24 July 2013) (Appendix 5);
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Web of Science (1945 to 24 July 2013) (Appendix 6);
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OpenGrey (to 24 July 2013) (Appendix 7).
No restrictions were placed on the language or date of publication when searching the electronic databases.
Searching other resources
Unpublished studies
Researchers, experts and organisations known to be involved in this field were contacted in order to trace unpublished or ongoing studies.
Handsearching
Only handsearching done as part of the Cochrane Worldwide Handsearching Programme and uploaded to CENTRAL was included (see the Cochrane Masterlist for details of journal issues searched to date).
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
Selection of studies
At least two review authors 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, a third review author was consulted. After assessment by the review authors, studies that did not match the inclusion criteria were excluded and the reasons for their exclusion were noted. If any of the studies of interest had multiple publications, these were identified and grouped under the same study.
No eligible studies meeting the inclusion criteria were found in the original review (published in 2010) and in the subsequent update (in 2014). If any studies were eligible for inclusion, the standard methods as outlined in the Cochrane Handbook for Systematic Reviews of Interventions would have been undertaken for data analysis and discussion of results (Higgins 2011).
Data extraction and management
Data would have been extracted independently by the two review authors using specially designed data extraction forms. For each trial included, the following would have been recorded and presented in study tables: the date that the study was conducted, the country, year of publication and its duration; details of study design, types of 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 or clarification of their publications or both.
Assessment of risk of bias in included studies
If any relevant studies had been identified, two review authors would have independently assessed the risk of bias using the Cochrane risk of bias assessment tool according to criteria described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Any discrepancies of ratings between review authors were to be resolved through discussions.
The following domains would have been assessed:
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sequence generation;
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allocation concealment;
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blinding (of participants, personnel and outcome assessors);
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incomplete outcome data;
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selective outcome reporting;
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other bias.
The review authors would have reported these assessments for included studies in a Risk of bias table in the included studies section in Review Manager (RevMan) (RevMan 2012).
Measures of treatment effect
For dichotomous outcomes, the estimate of effect of an intervention would have been expressed as risk ratios. Survival or time‐to‐event data would have been analysed as hazard ratios if data were available.
For any possible continuous outcomes, mean differences and standard deviations were to be used to summarise the data for each group. If different scales were used to measure the same outcome and these were considered to be similar enough for pooling, standardised mean differences would have been used to summarise the pooled data.
All measures of treatment effect were to be reported together with their respective confidence intervals.
Unit of analysis issues
The units of randomisation and analysis in the included trials would ideally all have been at the level of the individual. When split‐mouth studies were included and each individual trial participant had one tooth randomised to intervention and another randomised to control, analyses would have taken into account the paired nature of the data. In trials where the unit of randomisation was the tooth and the number of teeth included in the trial was not more than twice the number of participants, the data were to be treated as if the unit of randomisation was the individual. It was recognised that the resulting 95% confidence intervals produced would appear narrower (i.e. the estimate would seem to be more precise) than they should be, and would therefore have been interpreted accordingly.
Dealing with missing data
If studies met the inclusion criteria of the review, attempts would have been made to retrieve missing data from authors of trials. Methods for estimating missing standard deviations in section 7.7.3 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and techniques described by Follmann (Follmann 1992) would also be used to estimate the standard error of the difference for split‐mouth studies, where the appropriate data were not presented and could not be obtained.
Proportions of participants for whom outcome data were not provided would have been recorded in the summary of study characteristics table and also the risk of bias table. If missing data were significant, the risk would have been assessed by undertaking available case and intention‐to‐treat analyses and comparing these using sensitivity analysis.
Assessment of heterogeneity
Apart from statistical heterogeneity, clinical heterogeneity in terms of patient population, intervention, comparison and how outcomes were measured and reported would have been considered before any decisions to pool the data were made and in the description of results.
If more than one study was found and included in the meta‐analysis, forest plots would have been visually inspected for the presence of heterogeneity. Formal statistical tests using Cochran's Q statistic (Chi2 test with K‐1 degrees of freedom, where K is the number of studies) and the I2 statistic would have been used. Statistical heterogeneity would be considered as present if P value of Chi2 was 0.1 or I2 value was 50% or higher (Higgins 2011).
Assessment of reporting biases
Trials registers were searched and any completed studies which had not been published would have been identified. Outcome reporting bias would have been assessed as part of the risk of bias assessment as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
If sufficient studies were found and included, publication and other reporting biases would have been tested for using funnel plots and appropriate statistical tests.
Data synthesis
Meta‐analysis would only have been undertaken using comparable studies in which the same outcome measures were reported. Heterogeneity would have firstly been assessed by examining the types of participant, interventions and outcomes in each study. For dichotomous outcomes, the estimate of an intervention would have been summarised as risk ratios with 95% confidence intervals. Any continuous outcomes would have been recorded as mean differences with 95% confidence intervals. Random‐effects models would have been used for all analyses involving more than three trials otherwise fixed‐effect models were to be used.
If split‐mouth studies were included, this would have been combined with data from parallel group trials using the method outlined by Elbourne (Elbourne 2002), using the generic inverse variance method in RevMan.
Subgroup analysis and investigation of heterogeneity
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.
Sensitivity analysis
If sufficient studies were identified, sensitivity analysis would have been undertaken to assess the effects of randomisation, allocation concealment, missing data and blinding on the overall estimates of effect.
Results
Description of studies
Results of the search
The search strategy retrieved 298 references to studies after de‐duplication. After examination of the titles and abstracts of these references, full text copies of potentially relevant studies were sought and subjected to further evaluation. The bibliographical references of these studies were also examined but did not provide any additional citations to potentially eligible studies.
Included studies
None of the retrieved studies met our inclusion criteria.
Excluded studies
A full list of excluded studies is provided in the Characteristics of excluded studies section.
Multiple publications of two prospective cohort studies were found (Gordan 2006; Moncada 2006). Gordan 2006 had specified in their papers that randomisation was not possible across all treatment groups due to difficulty in obtaining Institutional Review Board (IRB) approval for randomisation; they only randomised when the options were to replace a restoration or provide no treatment. The authors of Moncada 2006 were contacted for clarification and confirmation of study design and the series of related publications. Participants in this study were not randomly allocated to treatment groups, they were assigned into groups dependant on defect type, therefore this study was also excluded.
Risk of bias in included studies
The searches retrieved no randomised controlled trials relevant to this systematic review and thus no assessments of methodological quality were conducted. If relevant trials had been identified then risk of bias would have been assessed as outlined in the Data collection and analysis section.
Effects of interventions
See: Summary of findings for the main comparison
Although 298 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
Summary of main results
No randomised controlled trials on the effects of managing defective resin composite restorations in permanent molar and premolar teeth by replacing (with resin composite) compared with repairing (with resin composite) were found.
Two prospective cohort studies with multiple treatment arms had included repair and replacement arms in their trials, but these studies could not be included because of lack of adequate randomisation (Gordan 2006; Moncada 2006).
Overall completeness and applicability of evidence
The aim of this review was to identify randomised controlled trials only, in addition the review authors aimed to compare the relative benefits and harms from these alternative ways of treating defective resin composite restorations. As such, the review was not able to utilise evidence from trials utilising other research designs, such as prospective cohort studies.
Quality of the evidence
No evidence from randomised controlled trials was found.
Potential biases in the review process
No studies meeting the inclusion criteria were found. The inclusion and exclusion process involved at least two review authors, and where information was unclear, the authors of studies were contacted for further clarification.
Agreements and disagreements with other studies or reviews
We were not aware of any other systematic review comparing repair versus replacement of resin composites for defective restorations in adults. There is another Cochrane review for the repair versus replacement of defective resin restorations; which also did not find any randomised controlled trials (Sharif 2014).
This review did not seek for non‐randomised studies, but we found two long‐term prospective cohort studies. These studies (Gordan 2006; Moncada 2006) reported the results for seven‐ and five‐year follow‐up respectively, and had suggested that repair is at least as effective as total replacement of resin composite restorations with localized defects.
| Repair compared with replacement of defective resin composite restorations in adults | |
| Patient or population: Adults with defective resin composite restorations in a molar or premolar tooth/teeth Settings: All dental settings Intervention: Repair of defective resin composite restoration (with resin composite) Comparison: Replacement of defective resin composite restoration (with resin composite) | |
| Outcomes | Comments |
| Success or failure of restoration, using a defined criteria | No randomised controlled trials were found |
| Further restoration required | |
| Presence of clinical symptoms (pain, swelling, diagnosis of pulpitis, abscess formation) | |
| Extraction of tooth (due to decay) | |
| Perioperative or postoperative pain or discomfort | |
| Patient satisfaction as measured by patient satisfaction or aesthetic scales | |
| Adverse events | |
| GRADE Working Group grades of evidence | |
