Dental fillings for the treatment of early childhood caries
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
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To compare restorative materials used in anterior and posterior primary classes I to V cavities in children with early childhood caries (ECC).
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To compare restorations versus extractions as an intervention in children with ECC.
Background
"Although dental problems don't command the instant fears associated with low birthweight, fetal death, or cholera, they do have the consequence of wearing down the stamina of children and defeating their ambitions. Bleeding gums, impacted teeth and rotting teeth are routine matters for the children... Children get used to feeling constant pain. They go to sleep with it. They go to school with it... Children live for months with pain that grown‐ups would find unendurable. The gradual attrition of accepted pain erodes their energy and aspirations... To me, most shocking is to see a child with an abscess that has been inflamed for weeks and that he has simply lived with and accepts as part of the routine of life. Many teachers in the urban schools have seen this. It is almost commonplace" (Kozol 1991).
Fass 1962 published the first comprehensive description of caries (tooth decay) in infants, which he termed "nursing bottle mouth". Over the next 40 years, countless papers have succeeded this, with much controversy and debate raging on in the dental literature as regards the nomenclature and case definition of the term early childhood caries (Wyne 1999). The dental profession has tried to find an ideal name for early childhood caries (ECC), one that could encompass all its risk factors and express the possible seriousness and rampant nature of the problem. This has led to ECC being called different names at different times based mainly on the clinical appearance and the suspected aetiological (causative) agent that was thought to cause the condition. Synonyms for ECC include labial caries, caries of the incisors, nursing bottle mouth, nursing bottle caries, nursing caries, baby bottle tooth decay, maxillary anterior caries, rampant caries, early childhood dental decay, milk bottle caries and bottle mouth caries. The clinical appearance of ECC includes the form of caries affecting all the primary upper anterior teeth, upper and lower primary first molars and the lower canines (the lower anterior teeth remain unharmed) to rampant caries affecting all the teeth in the mouth or small 'pockets' of decay affecting a single tooth in children. Primary teeth in young children are vital to their development as:
(1) Baby teeth hold a place and serve as spacers for the permanent teeth. Decay and early loss of these baby teeth can cause loss of space for the permanent teeth, which leads to the permanent teeth shifting and thus leads to orthodontic problems for the child.
(2) Healthy baby teeth are important in helping the child to speak clearly and develop self confidence (missing teeth, decaying teeth or bad breath can lead to a child getting teased by other children).
(3) Milk teeth are needed for biting and chewing. Without these teeth, a child will have difficulty eating health foods.
Hence, restorations (fillings) for this form of early onset caries in children is an important treatment option for the management of ECC. Other interventions for ECC include prevention and extractions.
It has been established that the group of cariogenic microorganisms (caries producing bacteria), mutans streptococci, is associated with ECC. Oral levels of these bacteria, which are generally acquired from the mother, were found to be elevated in children with ECC (Tinanoff N 1997). Other contributing factors that predispose children to ECC include prolonged and night‐time bottle feeding of milk and/or sweetened juice in infants and toddlers, 'at‐will' breast feeding, linear hypoplasia of primary teeth associated with malnutrition and the prolonged use of a pacifier covered with honey, sugar or other sweetened foods (Tinanoff N 1997).
Milnes 1996 reported that while the prevalence rate of ECC varied from 1 to 12% in developed countries, in developing countries and within disadvantaged populations of developed countries (immigrants, ethnic minorities) the prevalence rate is as high as 70%. The seriousness and societal costs of ECC continue to be a significant health issue, especially for children from racial/ethnic minorities and from developing countries. There is considerable evidence that children who experience ECC continue to be at risk of new lesions as they get older, both in the primary and permanent dentitions (Kaste 1992; Litt 1995; O'Sullivan 1996). ECC has also been implicated as contributing to other health problems. Children with ECC were shown to weigh less than 80% of their ideal weight and to be in the lowest 10th percentile for weight (Acs 1999). Low 1999 reported on the effect of severe caries on the quality of life in young children. They found that there was a significant change in pain complaint, eating preferences, quantity of food eaten, and sleep habits before and after treatment of dental caries. Finally and most importantly, the cost of restoring decayed teeth in ECC is extremely high and this cost increases when the costs for general anaesthesia or conscious sedation techniques are added (Weinstein 1998).
Given the above scenario of a high prevalence, high impact and high resource requirement for the management of ECC, oral health professionals need to make astute decisions about the type of restorative (filling) material they choose to best manage their patients. This decision is by no means an easy one as remarkable advances in dental restorative materials over the last 10 years are irrevocably changing the face of pediatric dentistry. Dentists are faced with a myriad of options when making clinical decisions regarding the type of restorative material to use for the management of ECC in the primary dentition. It is also apparent that the ideal restorative material for the primary dentition has not yet been developed. The popularity of any particular material has depended on clinical impression and fashion (Welbury 1997). However, in the era of evidence based dentistry, high patient demands and limited resources, the dental professional needs to have an evidence based approach when selecting materials for the restoration of primary teeth in children.
Objectives
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To compare restorative materials used in anterior and posterior primary classes I to V cavities in children with early childhood caries (ECC).
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To compare restorations versus extractions as an intervention in children with ECC.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) with a minimum period of 6‐months follow up.
Types of participants
Young children with tooth decay involving at least one tooth in the primary dentition which may be symptomatic or symptom free at presentation. (Since there is no universal acceptance of the definition of early childhood caries (ECC), we would look at fillings done in primary teeth in children of all ages and then do a subgroup analysis by age to check for heterogeneity among trials selected for this review).
Types of interventions
(1) All types of restorative materials used for restorations in the primary dentition, i.e. restorative materials used in Classes I to V cavity preparations (decay removed from the biting and/or side surfaces of teeth using drills), and the Atraumatic Restorative Technique (removing decay with hand instruments only). The main types of dental restorative materials that are used in the primary dentition are as follows:
(a) Metal restorations
‐Silver amalgam
(b) Glass‐ionomers
‐Traditional glass ionomer cements (self hardening)
‐Glass‐ionomer silver‐cermet cement
‐Resin‐modified glass‐ionomer cements
(c) Composite resins
‐Resin composites (light cure and self cure)
(d) Stainless steel crowns
‐Stainless steel crowns (primary molars and canines)
‐Stainless steel crowns with pre‐fabricated resin veneer facings
(e) Polyacid modified resin composites (Compomers).
One or more of the above types of restorative materials may be used in the different clinical situations (as described above); hence the need for developing best practices regarding the use of these materials to achieve different outcomes.
(2) Dental fillings versus dental extractions as a secondary intervention for the treatment of early childhood caries.
Exclusion criteria for considering studies for this review
Restorations for the management of ECC will normally include restorative materials used for treatment of pulpotomy and pulpectomy in primary teeth. However, this is the focus of another review entitled 'Pulp treatment for extensive decay in primary teeth' that is currently published in The Cochrane Library. Hence, restorations used for pulp treatment in the primary dentition will be excluded from this review.
Types of outcome measures
(1) The primary outcome measure will be pain relief, i.e. freedom from symptoms of pain and sensitivity as reported and experienced by the patient.
(2) Secondary outcome measures will include:
(a) Durability of restoration ‐ survival time of restoration (in months) from time of placement.
(b) Patient satisfaction with aesthetics ‐ as reported by patient or measured by an appropriate index for patient satisfaction.
(c) Weight gain/loss after intervention.
(d) Sleep habits following intervention.
(e) Adverse events.
(f) Marginal integrity of restoration.
(g) Wear and staining (colour changes) of restoration.
Search methods for identification of studies
For the identification of studies included or considered for this review, detailed search strategies will be developed for each database searched. These will be based on the search strategy developed for MEDLINE but revised appropriately for each database. The search strategy will combine the subject search with phases 1 and 2 of the Cochrane Optimal Search Strategy for RCTs (as published in Appendix 5b in the Cochrane Reviewers' Handbook 4.2.0 updated March 2003). The subject search will use a combination of controlled vocabulary and free text terms based on the search strategy for searching MEDLINE via OVID (seeAppendix 1).
Databases to be searched
The Cochrane Oral Health Group's Trials Register (to present)
The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library ‐ current issue)
MEDLINE (1966 to present)
EMBASE
LILACS
National Research Register UK
SCISEARCH (Science Citation Index)
ISTP (Index to Scientific and Technical Proceedings)
SIGLE (System for Information on Grey Literature in Europe).
Conference proceedings on early childhood caries, restorative materials for pediatric dentistry, and material sciences conferences for dental materials used for children's dentistry.
Language
The search will attempt to identify all relevant studies irrespective of language. Non‐English papers will be translated.
Handsearching
The following journals have been identified as being important to be handsearched for this review. Where these have not already been searched as part of the Cochrane Journal Handsearching Programme, the journals will be handsearched by the review authors:
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Operative Dentistry
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Journal of Restorative Dentistry
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Pediatric Dentistry
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Journal of Clinical Pediatric Dentistry
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International Journal of Paediatric Dentistry.
The reference lists of all eligible trials will be checked for additional studies.
Personal communication, mainly via e‐mail, will be established (if possible) with the author(s) of all eligible studies considered for inclusion in this review with the aim of obtaining information on additional published, unpublished or unlisted studies that may be eligible for inclusion in this review.
The manufacturers of dental materials will be contacted to obtain information on published and unpublished trials/studies that may have involved the materials that they manufacture. Companies will also be asked for reference lists that contain studies of dental materials that are used in the restoration of primary teeth.
Data collection and analysis
Study selection
The results of the search strategy will be screened independently by two review authors, (V Yengopal (JY), S Harneker (SH)), to determine whether they are potentially eligible. Full articles will be retrieved for all potentially relevant trials. Each trial report will be scrutinized for multiple publications from the same data set. JY and SH will independently assess each of these trials for inclusion in the review using an eligibility form based on the contents of the section 'Criteria for inclusion'. Any dispute regarding eligibility of an article will be resolved by discussion. If consensus cannot be reached, a third review author, N Patel (NP) will be consulted.
Data extraction
Two review authors (JY, SH), independently using specially designed data extraction forms, will extract the data from relevant studies. The data extraction forms will be piloted on several papers and modified as required before use. We will extract data on study characteristics including methods, participants, interventions, and outcomes. Any disagreements will be resolved by referral to the trial report and by discussion, or by consulting NP. Personal communication, mainly via e‐mail, will be established (if possible) with the author(s) of all eligible studies considered for inclusion in this review with the aim of obtaining additional information regarding his/her paper that may clear up uncertainties regarding the reporting of any aspect of the published study. Studies will be excluded until further clarification is available if agreement cannot be reached among the review authors. Excluded studies will be tabulated with reasons for exclusion described.
Where possible we will extract data to allow an intention‐to‐treat analysis (the analysis should include all the participants in the groups to which they were originally randomly assigned). If the number randomised and the numbers analysed are inconsistent, we will calculate the percentage loss‐to‐follow‐up and report this information in an additional table. For binary outcomes we will record the number of participants experiencing the event in each group of the trial. For continuous outcomes for each group, we will extract the arithmetic means and standard deviations. If the data are reported using geometric means we will extract standard deviations on the log scale. Medians and ranges will be extracted and reported in tables.
Quality Assessment
The quality assessment of the included randomised controlled trials will be undertaken independently by two review authors (JY and SH). They will assess the methodological quality of each trial in terms of generation of allocation sequence, allocation concealment, and loss to follow up. For each trial, generation of allocation sequence and allocation concealment will be classed as 'adequate', 'inadequate', or 'unclear' according to Juni 2001. Loss to follow up will be considered adequate if it is less than 10%. Blinding will not be feasible for these trials. This information will be displayed in an additional table and described in the section 'Methodological quality of included studies'. After including all eligible studies in the primary analysis, we aim to conduct sensitivity analyses for each of the quality factors using the subgroups adequate, inadequate, or unclear.
Further sensitivity analyses will be performed as follows:
(1) excluding unpublished studies;
(2) excluding studies of the lowest quality; and
(3) exclusion of one or more large studies (if found) to assess how much they dominate the results.
Data synthesis
Data will entered by JY into RevMan. Outcome measures for binary data will be compared using risk ratios. For continuous data, measured using the same scale, we will use the mean difference. If a variety of scales have been used to measure the same outcome in different trials and we cannot convert between scales, we will use standardised mean difference. If continuous data has been reported using geometric means we will combine the findings on a log scale and report on the original scale. Medians and ranges will be reported in tables only. We will assess heterogeneity amongst trials by inspecting the forest plots and using the Chi² test for heterogeneity with a 10% level of significance.
Where it is appropriate to pool data and heterogeneity is detected, we will use the random‐effects model. We do not intend to combine results of trials with different interventions. We intend to explore the following potential sources of heterogeneity using subgroup analyses:
(1) age of participants;
(2) location of restoration (anterior or posterior);
(3) type of cavity (class I ‐ V); and
(4) technique used in tooth preparation prior to placement of restoration (conventional or atraumatic restorative technique).
We will consider publication bias using a funnel plot. It is acknowledged that funnel plot asymmetry could be caused by publication bias, quality, or heterogeneity (Egger 1997).
