|Year : 2022 | Volume
| Issue : 4 | Page : 420-426
Cost-Effective analysis of silver diamine fluoride in comparison to glass ionomer cement along with fluoride varnish in the management of early childhood caries in anganwadi centers of Mangalore: A randomized control trail
Prakash Babu Kodali1, Vijaya Hegde2, Rasheed Minhaz2, P Prasanna Mithra3, Shubhan Alva2, Joe Joseph4, Roshni R S2
1 Department of Public Health and Community Medicine, School of Medicine and Public Health, Central University of Kerala, Kasaragod, Kerala, India
2 Department of Public Health Dentistry, A J Institute of Dental Sciences, Manipal, Karnataka, India
3 Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India
4 Department of Public Health Dentistry, Sree Mookambika Institute of Dental Sciences, Kanyakumari, Tamil Nadu, India
|Date of Submission||29-Nov-2021|
|Date of Decision||19-Sep-2022|
|Date of Acceptance||19-Oct-2022|
|Date of Web Publication||19-Dec-2022|
Department of Public Health Dentistry, A J Institute of Dental Sciences, NH-66, Kuntikana, Mangalore - 575 004, Karnataka
Source of Support: None, Conflict of Interest: None
Introduction: Early childhood caries (ECC) is a major public health challenge affecting preschool children. Silver diamine fluoride (SDF) is a noninvasive, alternative method to surgical intervention in the treatment of ECC. It has also shown to inhibit the development of new carious lesions. Materials and Methods: An open-labeled randomized controlled trail was conducted among 200 Anganwadi children. They were divided into two groups: Group A received oral prophylaxis and application of 38% SDF and Group B received oral prophylaxis, restoration using glass ionomer cement (GIC) and application of 5% sodium fluoride varnish (FV). The effectiveness in reduction of dental caries was assessed based on its ability to result in a positive outcome postintervention. Cost-effectiveness analysis, from the service provider perspective, was conducted to evaluate the effectiveness of SDF when compared to GIC followed by the application of FV. Average cost-effectiveness ratio and incremental cost-effectiveness ratio (ICER) for all the specific outcomes were assessed. Results: The average cost for converting an individual tooth from active caries to inactive caries using SDF was 67.30 Indian Rupees (INR), whereas the same was 225.5 INR using GIC with FV. The ICER of the interventions for the total number of inactive caries postintervention was measured at −89.9, implying that Incremental costs of one extra tooth of active caries to be converted into inactive caries using SDF will cost 89.9 INR less compared to the same outcome using GIC with FV. Conclusions: Thus, the study showed that SDF was cost-effective when compared to GIC in restoring active carious lesions.
Keywords: Analysis, cost, dental caries, glass ionomer cement, preschool children, silver diamine fluoride
|How to cite this article:|
Kodali PB, Hegde V, Minhaz R, Mithra P P, Alva S, Joseph J, RoshniR. Cost-Effective analysis of silver diamine fluoride in comparison to glass ionomer cement along with fluoride varnish in the management of early childhood caries in anganwadi centers of Mangalore: A randomized control trail. J Indian Assoc Public Health Dent 2022;20:420-6
|How to cite this URL:|
Kodali PB, Hegde V, Minhaz R, Mithra P P, Alva S, Joseph J, RoshniR. Cost-Effective analysis of silver diamine fluoride in comparison to glass ionomer cement along with fluoride varnish in the management of early childhood caries in anganwadi centers of Mangalore: A randomized control trail. J Indian Assoc Public Health Dent [serial online] 2022 [cited 2023 Mar 23];20:420-6. Available from: https://journals.lww.com/aphd/pages/default.aspx/text.asp?2022/20/4/420/364023
| Introduction|| |
Early childhood caries (ECC) is a public health problem affecting children in their early years of life. The prevalence of dental caries in India among preschool children varies from 19.2% to 71.1%. However, National Oral Health Survey 2002–2003 documented an average prevalence of 40.5% in Karnataka State and 40%–60% in the country. The Government of India initiated a national program known as the Integrated Child Development Services which aims at the delivery of basic nutrition, education, and health services through Anganwadi Centers. The Anganwadi workers provide nonformal education to preschool children between 3 and 5 years of age. Most of the preschool children belonging to low socioeconomic status attend Anganwadi schools. ECC often goes untreated and can have immediate and long-term effect on the quality of life of the child.
The standard of care for ECC has been primarily surgical and restorative treatment with relatively little emphasis on the prevention and management of disease. Another approach of treating dental caries in young children is atraumatic restorative treatment (ART). It is mostly indicated for use among children, because no rotary instruments are used and, in most cases, no local anesthesia is needed.
Silver diamine fluoride (SDF) is a noninvasive, alternative method to surgical intervention in treatment of ECC. It is an atraumatic approach for children which can slow the progression of caries so that the arrested decayed tooth exfoliates before causing oral pain. Apart from its caries-arresting effect, research has also shown the prevention of development of caries during critical early childhood periods. Federation dentaire internationale (FDI) promotes the prevention of ECC through fluoride in various health promotion strategies and programs. From a public health program perspective, resources are to be efficiently utilized to maximize the gains. However, there is an unclear picture on which of the two treatments are cost-effective in converting the teeth from active caries to inactive caries.
Moreover, for successful implementation in large scale program settings, interventions should be effectively implementable in a limited-resource setting. The cost-effectiveness analysis of SDF would further add to exploring the feasibility of implementing the method in limited resource setting. From a public health perspective, limited resources need to be utilized efficiently to realize the largest health care gain. This study was carried out to assess the cost effectiveness of SDF when compared to glass ionomer cement (GIC) along with fluoride varnish (FV) in the management of ECC among Anganwadi children.
| Materials and Methods|| |
An open-labelled randomized controlled trial was conducted among Anganwadi children of Mangaluru City, a coastal city in the Southern Indian State of Karnataka. A parallel type study design was conducted where for Group A, SDF was applied on the carious lesion and for Group B the carious lesions were restored with GIC followed by Sodium FV application. The sample size for this trial was calculated with an anticipated effect size of 0.45, 95% confidence interval, 80% power, 1:1 allocation, using G*power, version 3.0.1 (Franz Faul Universitat, Kiel, Germany). Further, 20% was added to reach a final sample size of 190 (95 in each group) to compensate for the loss to follow-up. After obtaining clearance from the Institutional Ethics Committee of AJ Institute of Dental Sciences, Mangalore (AJEC/REV/239/2018), the trial was also registered with Clinical Trials Registry-India (CTRI/2019/02/017590). Necessary permissions were obtained from the concerned health and administrative authorities for the visits to selected Anganwadi centers. A total of 26 Anganwadi centers which were in close proximity to the research institute were chosen.
Randomization and treatment allocation
The children in the Anganwadi centers were randomly divided into two groups using computer-generated random allocation. Random allocation was done by the principal investigator. There was no blinding involved in the study.
Group A: Oral prophylaxis and application of 38% SDF.
Group B: Oral prophylaxis, restoration using GIC and application of 5% Sodium FV.
The Anganwadi centers were visited for intervention and data collection. It was done for a period of 20 days. The intervention done varied each day based on number of children to whom treatment was provided. The parents of children were contacted and explained about the intervention in a language that they understood and a written Informed consent was obtained from one of the parent of every child. The children who had at least 1 tooth with untreated active carious lesion(s), extending into the dentin were included in the study and those who were uncooperative and difficult to manage, were excluded from the study. A total of 200 children were recruited in the study and divided into two groups with 100 children in each group.
At baseline each participating child attended an oral health education session using study models and their caries status was assessed based on Nyvad's Criteria.
The operator was assisted by an auxiliary in preparing the patient, providing the material and the instruments. For Group A, the decayed tooth was isolated with cotton rolls and SDF was applied using UCSF protocol. For Group B, the ART using GIC was done using Hand instruments, and FV was applied to all the remaining teeth. The Anganwadi centres were visited again after 6 months and the caries status was again reassessed and FV was applied to Children belonging to Group B. The study followed the CONSORT guidelines [Figure 1].
|Figure 1: Flow chart of participant randomization and outcome assessment|
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The cost-effectiveness analysis was conducted in three stages: (i) identification of costs, (ii) identification of the outcomes, and (iii) calculation of the cost-effectiveness ratios (average cost-effectiveness ratio (ACER) and incremental cost-effectiveness ratio [ICER]).
Identification of cost
The actual costs of individual interventions (SDF and GIC with FV) were identified for the financial year 2019–2020. The actual costs were identified through expense statements and bills incurred for implementing the interventions. The costs were captured under various heads such as equipment costs, human resources, transportation, and recurring expenditure. Since the cost data were identified during the same financial year as study, the costs included in analysis were actual and not inflation adjusted. The future value of the costs was discounted to the value of the year in which the study was conducted using the formula:
The present value of the cost reflects the total cost of individual interventions after discounting. T was the time period taken as 1 year. A discount rate of 3% was assumed as per WHO CHOICE approach marking the value of r to be 0.03. The discounted costs for total costs were computed and rounded off to the nearest whole number.
Identification of outcome
The effectiveness of the intervention was assessed based on its ability to result in a positive outcome postintervention (i.e., inactive caries postintervention). The diagnosis of the caries (both at the baseline and postintervention) was done using Nyvad's criteria, through oral examination by certified dental physician. Primarily, three types of positive outcomes were assessed in both the intervention groups. They include (i) inactive caries with intact surface, (ii) inactive caries with surface discontinuity, and (iii) inactive caries cavity. In the intervention group with GIC and FV treatment, Filling with sound surface and filling with inactive caries were added to the positive outcome of inactive caries cavity, as filling of caries cavity is the part of intervention. In addition, a fourth outcome “total number of teeth with inactive caries” was computed, to assess the overall effect of the individual interventions.
Two types of cost-effectiveness ratios (ACER, and ICER) were calculated for all the specific outcomes discussed above. The cost-effectiveness ratios reflect the cost for treating individual teeth using SDF or GIC with FV. The ACER and ICER were computed across the outcomes for actual costs and discounted costs.
The ACER was computed by substituting cost and outcome values of the interventions in the following formula.
Where Ci reflect the total cost of the intervention (SDF or GIC with FV) and Ei reflect the specific outcome under study (i.e., inactive caries with intact surface, inactive caries with surface discontinuity, inactive caries cavity, and total number of teeth with inactive caries).
The ICER was computed by substituting the cost and outcome values in the following formula.GIC with FV
CSDF represent the total cost of intervention with SDF, CGIC with FV represent the total cost of intervention using GIC with FV, ESDF represent the effect of SDF postintervention across the outcomes under study, EGIC with FV represent the effect of GIC with FV postintervention across the outcomes under study.
| Results|| |
A total of 200 children (100 in each group) aged 1–5 years were sampled for the study. After the initiation of study, 9 children from the SDF group and 4 children from GIC with FV group were lost to follow-up at 6 months after the initial intervention. The final study participants included a total number of 187 children aged 1–5 years. Specifically, 91 (48 male, 43 female) of them were assigned to the experimental group with SDF as intervention and 96 (44 male, 52 female) participants were assigned to the control group with GIC and FV as intervention. A total of 283 and 361 teeth were identified with active caries at baseline in the GIC and SDF groups, respectively.
The total cost for delivering the intervention using SDF was 20800 Indian Rupees (INR), the same was 35,800 INR for GIC with FV. The costs were discounted using a discount rate of 3%. The detailed outline of actual costs incurred for the individual intervention and discounted costs is provided in [Table 1].
|Table 1: Costs in Indian rupees incurred for providing the interventions using silver diamine fluoride and glass ionomer cement|
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Dental caries in intervention and control groups
The oral examination and application of interventions was conducted by a trained dental physician supported by an auxiliary. Number of teeth with active caries and inactive caries was assessed in both the groups at the baseline and after intervention. None of the intervention groups had inactive caries of any form at baseline before the intervention. At baseline, the group receiving the intervention with GIC and FV had a total 283 teeth. On the other hand, the group receiving intervention with SDF had a total of 361 teeth with active caries.
It was observed that intervention with SDF resulted in a better conversion of active caries into inactive caries compared to GIC with FV. While the total number of teeth with inactive caries postintervention for Group with SDF was 12, 80 and 223 for intact surface, surface discontinuity and caries cavity respectively, the same was 5, 29, and 123, respectively, for Group with GIC and FV. Overall a total of 157 teeth with active caries were converted to inactive caries in the group receiving GIC with FV and 315 teeth with active caries were converted to inactive caries in the group receiving SDF. The detailed description of the status of carious lesion before and after intervention in each of the groups is given in [Table 2].
|Table 2: Distribution of caries before and after intervention across the intervention groups based on Nyvad's criteria|
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Cost-effectiveness of the interventions
Cost-effectiveness ratios (ACER and ICER) were computed across the outcomes to compare the costs and effects between the intervention groups of SDF and GIC with FV. The cost-effectiveness ratios were computed both for actual costs and discounted costs. It was observed that SDF was cost-effective in treating active caries into inactive caries among children aged 1–5 years compared to GIC with FV.
The average cost for treating an individual tooth from active caries to inactive caries using SDF was 67.30 INR, whereas the same was 225.5 INR using GIC with FV. Comparison of these two ratios signifies that average cost of treating active caries is less with SDF. Similar observations were made with regard to various types of caries outcomes.
The ICERs were computed to compare the costs and effects of the interventions (SDF and GIC with FV), across the caries outcomes postintervention. The ICER of the interventions for the outcome total number of inactive caries postintervention was measured at −89.9, implying that Incremental costs of one extra tooth of active caries to be converted into inactive caries using SDF will cost 89.9 INR less compared to the same outcome using GIC with FV. This implies that in the context of converting active caries into inactive caries, treatment with SDF is both cost-saving and effective when compared with treatment GIC and FV. Similar observations were made with regard to specific caries outcomes and are outlined in [Table 3].
|Table 3: Cost effectiveness ratios of the interventions across the types of outcome|
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| Discussion|| |
The prevention of dental caries is important to improve the oral health-related quality of life of children. The most frequently applied approaches are restoring the tooth with GIC and applying FV to prevent the development of caries. However, this approach will cost more per patient, which stems from the time, manpower and equipment required. In order to reduce the burden of ECC among preschool children in a limited resource setting, there is an urgent need of effective, cost-effective, and feasible oral health promotion program.
The observations from the current study reported that SDF is effective in arresting the progression of dental caries and converting active caries into inactive caries, compared to filling with GIC and applying FV [Table 2]. The effectiveness of SDF as a treatment to arrest active caries in primary dentition is documented in existing literature., Moreover, it was also observed that SDF was less costly in treating dental caries compared to GIC and FV. The average cost per child using SDF was approximately INR 233/- (total cost of INR 21,200), whereas the average cost of treating the child using GIC and FV was approximately INR 385 (total cost of INR 35,400). The major cost drivers could be observed in the treatment group with GIC and FV in the form of equipment and materials required for treatment using GIC and FV [Table 1]. The lack of need for complicated equipment (including the costs for their purchase and maintenance) and comparatively low-cost of the materials (SDF) made treatment with SDF less costly compared to its counterpart. Existing evidence support these observations as literature claims that SDF is often used as a less invasive topical application requiring minimal equipment. In contrary filling the carious lesion with GIC requires at least portable equipment adding up to its costs.
The ACER and ICERs were calculated as the measure of cost-effectiveness of the interventions [Table 2]. It could be observed that the ACER and ICER per tooth for the outcome's inactive caries with intact surface and inactive caries with surface discontinuity are higher compared to the outcome of inactive caries cavity. This is primarily due to the fact that the prevalence of active caries with intact surface and active caries with surface discontinuity in both the intervention groups at the baseline are less than active caries cavity at baseline [Table 2]. Moreover, it was consistently observed that the intervention group with SDF treatment has lower cost to unit effect (i.e., individual tooth treated to inactive caries of particular diagnostic type) both for actual costs and discounted costs, signifying that treatment with SDF is both effective and cost saving compared to GIC and FV. Overall, the average cost per treating a single tooth with active caries to inactive caries using SDF costs less than a dollar (i.e., INR 67.30). Similar observations were observed by earlier studies assessing the cost effectiveness of SDF. One study from Argentina reported the cost of stabilizing one dental lesion using SDF as USD 1.08$. A recent systematic review also reports SDF as a cost-effective in arresting caries compared the other methods such as sealants.
These results signify that SDF could serve as a cost-effective means to arrest and prevent dental caries in primary dentition. Moreover, application of SDF is often noninvasive, requiring limited professional dental infrastructure (such as dental chair with illumination, fluid evacuation to maintain dry field etc.,) and minimal training. Hence, SDF can be considered as a costly effective alternative in school-based and community-based oral health programmes.
It has to be noted that while SDF is cost-effective compared to GIC with FV, the effectiveness of SDF is primarily concerned with arresting the active caries to inactive caries. Whereas, the effectiveness of GIC is concerned by restoring an active carious lesion. This could be observed from the results of the study where majority of inactive caries postintervention in GIC group is contributed by filled teeth with sound surface [Table 2]. However, it could also be observed that the marginal improvement using GIC is comparatively less than SDF. Moreover, high costs of material, equipment and an absolute need for trained professionals to provide the intervention, undermine the absolute effectiveness of GIC when compared with SDF.
In a public health setting where the goal is reduction in the caries with a limited budget, SDF seems to be a cost-effective alternative over GIC with FV.
The current study provides a cost-effective analysis of two caries preventive agents. Taking costs into account, our analyses suggest that using SDF is more cost-efficient than GIC, particularly on active cavitated lesions which turned into inactive cavitated lesions.
The limitation of the study is that it assessed the effectiveness after a follow-up of only 6 months; however, longer follow-up considering the arrest of carious lesion, the dosage, parental acceptability, and interval of application would have given more insight.
Further studies are required to know the effectiveness in community-based dental health programs.
| Conclusions|| |
The present study provides an understanding of the costs associated with the treatment provided and concludes that SDF was cost-effective and this could be implemented in similar settings elsewhere and also help in formulating community based dental health interventions to reduce the burden of ECC.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]