Atraumatic restorative treatment versus conventional restorative treatment for the management of dental caries
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects of 'true' Atraumatic Restorative Treatment (ART) for the treatment of decayed deciduous and permanent teeth in children and adults.
Background
Dental caries
Dental caries is a sugar‐dependent disease that damages tooth structure and may result in cavity formation in the hard tissues of the teeth (enamel, dentine and cementum) (Kidd 2005). Dental plaque is a biofilm formed on the tooth surface soon after tooth cleaning. It frequently contains caries producing bacteria such as mutans streptococci. Such microorganisms metabolise dietary sugars and produce acids on the tooth surfaces. The acid production could lead to the diffusion of calcium and phosphate ions and, consequently, demineralization of enamel. If this process continues, loss of mineral components will eventually lead to cavitation.
Dental caries has been considered the most important global oral health burden. It affects 60% to 90% of school‐aged children and up to 100% of adults in the majority of countries (Petersen 2005). Apart from the high cost of treatment, the related pain and discomfort affects peoples’ quality of life.
Conventional restorative treatment
The ultimate goal for the treatment of dental caries is to halt the destructive process of cavitation by removing the demineralized tooth tissue and to restore the tooth to function by replacing the affected parts of the tooth structure. The conventional methods involve the use of rotary burs, alone or in conjunction with metal hand instruments. Dental restorative materials used vary and range from metal based materials such as amalgam, the most popular dental restoration material especially in the posterior teeth, to tooth‐coloured materials, such as resin composites.
The pain and discomfort associated with conventional cavity preparation methods have resulted in many patients being reluctant to seek dental treatment (Berggren 1984). Local anaesthesia is frequently needed to control the pain. Factors potentially responsible for the discomfort and pain include: the sensitivity of vital dentine; the pressure on the tooth caused by mechanical stimulation of the tooth by rotary devices; bone‐conducted noise and vibration; the high‐pitched noise of the rotary device; and development of high temperatures at the cutting surface (thermal stimulation) (Banerjee 2000). In addition, an important limitation of the conventional restorative methods is that they require an electricity supply, expensive handpieces and highly trained dental health personnel. These factors limit the use of conventional restorative dentistry in many underdeveloped areas where facilities and trained human resources are scarce.
Atraumatic Restorative Treatment
To overcome the limitations of conventional restorative treatment, the Atraumatic Restorative Treatment (ART) was developed around 1985 mainly for treating caries in children living in under‐served areas of the world where resources and facilities such as electricity and trained manpower are limited (Frencken 1996). ART is a minimal intervention approach (Tyas 2000) and is recommended by the World Health Organization. The 'true' ART technique involves removing soft, demineralized tooth tissue using only hand instruments followed by restoration with an adhesive dental restorative material. ART has been used in many countries.
The advantages of this treatment compared with conventional restorative techniques using dental handpiece and burs include: provision of restorative dental treatment outside the dental surgery setting, a biologically friendly approach, minimal cavity preparations and low costs (Frencken 1999; Mjör 1999; Yip 2001; Yip 2002), reduced risk for subsequent endodontics and tooth extraction (Anusavice 1999) and lower dental anxiety in children and adults (more patient‐friendly) (Mickenautsch 2007; Schriks 2003). These advantages are particularly important in developing countries, where electricity supplies are intermittent and people have difficulties accessing dental care. In addition, elderly, medically‐compromised (e.g. HIV infected) and dental phobic patients who have problems accessing dental care would benefit from the ART approach (Cole 2000; Honkala 2002; Steele 2007).
Glass‐ionomer cements (GICs) are the predominant restorative materials used for ART (Yip 2001). GIC restorative materials have advantages such as the ability to bond chemically to enamel and dentine, biocompatibility with pulpal tissue and less potential to induce recurrent caries, inhibition of enamel demineralization, good cavity seal, ease of use and low costs (Frencken 1996; van 't Hof 2006).
Recently, modified ART approaches have been introduced, as opposed to 'true' ART, which was described above. These modified approaches involve opening the cavity with a drill, cleaning, restoring and finishing with hand instruments, or using alternative restorative materials including amalgam (Monse‐Schneider 2003). Also, some studies applied ART‐type GICs as pit and fissure sealants using different methods such as the press‐finger method (Yip 2002). These modified ART approaches are not considered as a 'true' ART.
Apart from these modified approaches, the American Academy of Pediatric Dentistry (AAPD) (AAPD 2008‐2009) introduced the Interim Therapeutic Restorations (ITR) approach which uses almost the same technique as ART, although it may have different therapeutic goals. The ITR procedure involves removal of caries using hand or slow speed rotary instruments, as opposed to ART which uses only hand instruments, followed by restoration with an adhesive restorative material such as self‐setting or resin‐modified glass ionomer cement. While ART is recognised as a permanent treatment, the AAPD regards ITR as a provisional technique. The ITR, according to AAPD, may be used "to restore and to prevent dental caries in young patients, uncooperative patients, patients with special health care needs, and situations in which traditional cavity preparation and/or placement of traditional dental restorations are not feasible; it may be used for caries control in children with multiple carious lesions prior to definitive restoration of the teeth" (AAPD 2008‐2009). Based on the AAPD definition, if ITR is applied using hand instruments, and not rotary instruments, it can then be considered as a 'true' ART.
Why it is important to do this review
The ART approach seems to be an economic and effective method for improving the oral health not only of people in developing but also of those in industrialised countries (Frencken and Holmgren 2004). It may be considered as a safe and conservative alternative for conventional restorative dental treatment, particularly for Class I (occlusal) dental cavities. Because of the advantages claimed for ART, it is important to systematically review the evidence available. The available systematic reviews on studies comparing the ART approach with conventional approach have limitations including restricting the search to only one electronic database (MEDLINE) and English language studies (Frencken 2004; van 't Hof 2006) and not assessing the quality of included studies (van 't Hof 2006). The present study aims to systematically review randomised controlled studies and quasi‐randomised controlled trials comparing 'true' ART with conventional restorative approaches.
Objectives
To assess the effects of 'true' Atraumatic Restorative Treatment (ART) for the treatment of decayed deciduous and permanent teeth in children and adults.
Methods
Criteria for considering studies for this review
Types of studies
All randomised controlled trials or quasi‐randomised controlled trials will be included.
Non‐randomised controlled trials will be excluded.
Types of participants
Dentate participants, regardless of the age and sex, with a history of dental (coronal or root) caries who have undergone restorative treatment using either conventional restorative or ART approaches.
Types of interventions
Interventions are adhesive restorative materials, such as GICs with different viscosities, placed with the 'true' Atraumatic Restorative Treatment (ART) approach, including ITR with hand instruments, compared with different restorative materials, such as amalgam, placed with conventional cavity preparation methods. Studies on modified ART approaches will be excluded.
Types of outcome measures
Primary outcome measure
1. Pain relief, i.e. freedom from symptoms of pain and sensitivity as reported and experienced by the patient.
2. Restoration failure, e.g. replaced restorations.
Secondary outcome measures
1. Durability of restoration ‐ survival time of restoration (in months) from the time of placement.
2. Marginal integrity of restoration.
3. Secondary caries.
4. Defects of restorative materials such as wear, fracture and staining (colour changes) of restoration.
5. Aesthetics ‐ as reported by patient (e.g. measured by an appropriate index for patient satisfaction) or the operator.
6. Surface changes (changes in texture).
7. Patient discomfort during the procedure measured by physiological measurement or behavioural observation.
8. Patient's anxiety and stress after treatment.
9. Sleep habits following intervention.
10. Weight gain/loss after intervention.
11. Adverse events.
12. Fatigue in operator.
14. Need for monitoring and after‐care of restorative treatment.
15. Operator effect.
Costs
Direct cost of treatment. Time off school or work to attend the dental visits by the patient.
Search methods for identification of studies
We will attempt to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress).
Electronic searches
For the identification of studies included or considered for this review, detailed search strategies will be developed for each database to be searched. These will be based on the search strategy developed for MEDLINE but revised appropriately for each database (Appendix 1).
The search strategy will combine the subject search with the Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying reports of randomised controlled trials in MEDLINE (as published in Box 6.4.c in the Cochrane Handbook for Systematic Reviews of Interventions version 5.0.1 updated September 2008) (Higgins 2008).
The following bibliographic databases and trials registers will be searched:
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The Cochrane Oral Health Group's Trials Register (to present)
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The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, current issue)
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MEDLINE (OVID) (1950 to present, including OLDMEDLINE (1950 to 1965))
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EMBASE (1974 to present)
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Regional bibliographic databases such as LILACS/BBO (1982 to present), IndMED (India), Chinese Biomedical Literature Database (CBM) (in Chinese)
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Grey literature databases such as SIGLE (1980 to present).
We will also search the Current Controlled Trials metaRegister of Controlled Trials (mRCT) ‐ active registers (www.controlled‐trials.com/mrct/) for any ongoing trials on the relevant topic.
Searching other resources
Handsearching
We will contact the Cochrane Oral Health Group and identify any dental and oral surgery journals which are appropriate for this research question and arrange to handsearch those which have not already been handsearched as part of the Cochrane Collaboration's global handsearching programme.
Reference lists
We will examine the reference lists of relevant trials, reviews, articles and text books in an attempt to identify any other studies or those not identified in previous searches.
Correspondence
Organisations, researchers and experts known to be involved in the field will be contacted, either by conventional or electronic mail, in an effort to trace unpublished or ongoing studies. Manufacturers will also be contacted to identify any ongoing or unpublished studies.
Data collection and analysis
Identification of reports produced by the searches
The downloaded set of records from each database will be imported to the bibliographic software package Endnote and merged into one core database to remove duplicate records and to facilitate retrieval of relevant articles. All potentially relevant reports identified when searching other sources (reference lists of relevant trials, reviews, articles and textbooks) will also be obtained and the records located from searching these (non‐electronic) sources will be entered manually in Endnote.
Selection of studies
All records identified by the searches will be printed off and checked on the basis of title first, then by abstract or keywords or both. Records that will be obviously irrelevant will be discarded and the full text of all remaining records will be obtained.
The full reports obtained from all the electronic and other methods of searching will be assessed independently by two review authors (Aubrey Sheiham (AS) and Mojtaba Dorri (MD)) to establish whether the studies meet the inclusion criteria or not, using an inclusion criteria form, which will be previously prepared and pilot tested. Disagreements will be resolved by discussion. Where resolution is not possible, a third review author (Valeria Marinho (VM)) will be consulted.
Attempts will also be made to contact authors of articles that cannot be classified in order to ascertain whether inclusion criteria are met. It will be essential to identify and check all reports related to the same study; and in case of any discrepancy, authors will be contacted.
If more than one publication of a trial is identified, all publications will be reviewed and the paper with the first publication date will be included as a primary version.
All studies meeting the inclusion criteria will then undergo data extraction and a quality assessment. Studies rejected at this or subsequent stages will be recorded in the table of excluded studies, and reasons for exclusion will be recorded. Studies in foreign languages will be translated as appropriate prior to data extraction/methodological assessment.
Data extraction and management
Data from all included studies will be extracted independently by two review authors (AS and MD) using a pilot tested data extraction form. Extracted data will be entered separately by each of two review authors into the 'Characteristics of included studies' table in Review Manager (RevMan) 5 (RevMan 2008) and automatically checked for differences. Data will only be included if there is an independently reached consensus. Disagreements will be resolved by a third review author (VM) until consensus is obtained. MD will hold the master copy. All trial authors will be contacted for clarification or missing information. Data will be excluded until further clarification is available or if agreement cannot be reached. Papers in languages not known by the review authors will be data extracted with help from appropriate translators. Studies with duplicate publications will be treated as a single source of data. Review authors will not be blinded to the names of the authors, institutions, journal of publication or results of the studies. The level of agreement (Kappa) between review authors will be calculated.
The following details will be recorded for each trial in the data extraction form.
Trial characteristics
The main details of the study such as year of publication; reference/source; language of publication; country of origin; year the study started; number of participants at the start of the study; and age groups of the participants. Additional information related to study methodology or quality that will be extracted include: study duration (months/years of follow‐up); comparability of baseline characteristics; methods used pre‐randomisation in sizing/balancing (stratification based on relevant variables) or used post‐randomisation in analysing/adjusting for possible differences in prognostic factors between groups; method of allocation; masking of participants, outcome assessors and personnel; objectivity/reliability of primary outcome measurement; exclusion of participants after randomisation; proportion of follow‐up losses, and any co‐intervention or contamination or both.
Participants characteristics
Characteristics related to participants that will be extracted include: age of the participants; sex; inclusion and exclusion criteria; location where study was conducted (country); setting where participants were recruited; and baseline dmfts/DMFTS of the study population where available.
Intervention characteristics
Characteristics of the intervention that will be extracted include: type and viscosity of restorative materials; type and number of operators; instruments used; length of procedure.
Control characteristics
Characteristics of the control that will be extracted include: type of restorative material and method of application; type and number of operators; instruments used; length of procedure.
Outcome characteristics
Characteristics of the primary and secondary outcomes as stated above will be extracted. Also information on whether measures have been taken to control for possible confounding factors and dependency of data will be sought.
Any adverse events assessed or reported in the trials will also be recorded. Information regarding contact address of the authors, sponsoring institutions and manufacturers will be recorded. All other relevant outcomes assessed/reported in the trials will be also recorded/listed.
Assessment of risk of bias in included studies
The assessment of risk of bias of all the included trials (or internal validity) will be undertaken independently and in duplicate by two review authors (AS and MD) as part of the data extraction process. This will be carried out according to the criteria for assessing the main domains of risk of bias (as 'Yes' (i.e. low risk of bias), 'No' (i.e. high risk of bias), or 'Unclear' (i.e. unclear risk of bias)), as described in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions 5.0.1 (updated September 2008) (Higgins 2008):
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Sequence generation: was the allocation sequence adequately generated?
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Allocation concealment: was allocation adequately concealed?
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Blinding of participants, personnel and outcome assessors: was knowledge of the allocated intervention adequately prevented during the study?
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Incomplete outcome data: were incomplete outcome data adequately addressed?
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Selective outcome reporting: are reports of the study free of suggestion of selective outcome reporting?
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Other sources of bias: was the study apparently free of other problems that could put it at a high risk of bias?
A standardised quality assessment form will be developed which will include the criteria for assessing the above domains of risk of bias and data will be entered in the 'Risk of bias table' in RevMan 5 (RevMan 2008).
The potential risk of bias for each study will then be summarized and the studies will be grouped into the following three categories:
(A) Low risk of bias: plausible bias not likely to seriously alter the results (if low risk of bias for all items);
(B) Unclear risk of bias: plausible bias that raises some doubt about the results (if unclear risk of bias for one or more key items); and
(C) High risk of bias: plausible bias that seriously weakens confidence in the results (if high risk of bias for one or more key items), as described in Section 8.7 of the Cochrane Handbook for Systematic Reviews of Interventions 5.0.1 (updated September 2008) (Higgins 2008).
Data synthesis
The Cochrane Collaboration statistical guidelines will be followed for data synthesis. The data will be analysed by MD using RevMan 5 and reported according to Cochrane Collaboration criteria.
Results of clinically and statistically homogeneous trials will be pooled to provide estimates of the efficacy of the interventions only if the included studies have similar interventions received by similar participants. Number needed to treat to benefit (NNTB) and number needed to treat to harm (NNTH) will be calculated for the whole pooled estimates.
For the synthesis and meta‐analysis of any quantitative data we will use the random‐effects models.
In the event that there are insufficient clinically homogeneous trials for any specific intervention or insufficient study data that can be pooled a narrative synthesis will be presented.
Measures of treatment effect
Data obtained from visual analogue scales and any categorical outcomes will be converted if appropriate into dichotomous data prior to analysis.
Continuous data
For continuous data the mean difference and 95% confidence intervals will be calculated.
Dichotomous data
Risk ratios and their 95% confidence intervals will be calculated for all dichotomous data.
Dealing with missing data
We will contact the study authors to clarify incompletely reported data related to trial characteristics, methodology and outcomes when possible.
Assessment of heterogeneity
We plan to assess clinical heterogeneity by examining the characteristics of the studies: the similarity between the types of participants, the interventions and the outcomes as specified in the criteria for included studies. Statistical heterogeneity will be assessed using a Chi2 test and the I2 statistic where I2 values over 50% indicate moderate to high heterogeneity (Higgins 2003).
Assessment of publication bias
If sufficient randomised controlled trials (RCTs) are identified, an attempt will be made to assess publication bias using a funnel plot (Egger 1997).
Sensitivity analyses
If there are sufficient included studies we plan to conduct sensitivity analyses to assess the robustness of our review results by repeating the analysis with the following adjustments: exclusion of studies with unclear or inadequate allocation concealment, unclear or inadequate blinding of outcomes assessment and completeness of follow‐up.
Subgroup analyses
If there are sufficient information available, subgroup analyses may be carried out for age, setting, initial caries, dental caries type/site, tooth type/location, type of operator, and viscosity of restorative materials.
