EFFECTIVENESS OF SILVER DIAMINE FLUORIDE AND SODIUM FLUORIDE VARNISH IN ARRESTING DENTAL CARIES AMONG 6-15 YEAR OLD CHILDREN OF DESTITUTE HOMES IN MYSORE CITY, INDIA
Background: In developing countries, the prevalence of untreated caries ranges from 30% to 90% in 12 years old children. Arrest of caries techniques (ACT) present a set of appropriate oral health care technologies for disadvantaged communities. Silver diamine fluoride (SDF) has been used in this way for more than 25 years. Sodium fluoride varnish (SFV) is one of the common topical fluorides used in the management of dental caries.
objectives: To assess and compare the effectiveness and feasibility of silver diamine fluoride and sodium fluoride varnish in arresting dental caries.
Methodology: After baseline examination, 251 children residing in destitute homes of Mysore city, with at least one active cavitated carious lesion were randomly allocated to 2 groups. Children in the I group received annual application of 38% silver diamine fluoride and II group received quarterly application of 5% sodium fluoride varnish on the carious lesions.204 children were followed for 18 months.
Results: Mean number of arrested lesions at 6 months was 1.961.21 for SDF group and 0.84 0.80 for SFV group, at 12 months it was 1.501.16 for SDF group and 0.42 0.55 for SFV group and 18 months it was 1.671.24 for SDF group and 0.19 0.42 for SFV group (P < .000).
Conclusion: Silver diamine fluoride was found to be effective in arresting dental caries. For the disadvantaged population, an outreach service using simple armamentarium such as SDF therapy would be feasible means of providing cost effective care.
Dental caries is an infectious disease that has afflicted the human race since ancient times. Dental caries is a public health problem in most countries.1
Though dental caries is preventable, the application of preventive measures in remote areas with inadequate dental manpower coupled with lack of community education and involvement have been ineffective. The restorative care is not provided because they are not available, or require sophisticated and expensive equipment, extensively trained personnel and also electricity.2 This makes untreated dental caries one of the most prevalent childhood diseases. In developing countries, the prevalence of untreated caries ranges from 30% to 90% in 12 year old children.3 The dental caries is the leading cause of loss of teeth in children.
Progression of dental caries in children can lead to pain, infection and loss of function. There is clinical evidence that incipient and even more advanced carious lesion may become arrested if there is significant shift in oral environmental conditions from those that predispose to those that tend to slow the caries process.4
Arrest of caries techniques (ACT) present a set of appropriate oral health care technologies for disadvantaged communities.2 Caries arresting treatment that aims to halt or slow down caries progression is a practical solution to minimize children’s discomfort and problems due to caries. These techniques aim to arrest decay but do not aim to restore the damaged tooth structure.2 Silver diamine fluoride (SDF) have been used for more than 25 years.5 Sodium fluoride varnish (SFV) is one of the common topical fluorides used. Studies regarding the effectiveness of these materials in arresting dental caries are scanty in India.
Hence, this field study was conducted to assess the effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dental caries among 6-15 year old children of destitute homes in Mysore city.
To assess and compare the effectiveness of 38% silver diamine fluoride solution and 5% sodium fluoride varnish in arresting dental caries among 6-15 year old children of destitute homes in Mysore city.
To find the feasibility of these materials in arresting dental caries.
Source of data
Data was collected from the oral examination of all the available children in the age group of 6-13 years residing in all the destitute homes of Mysore city.
Method of collection of data
List of destitute homes in Mysore city was collected from the Departments of Women and Child Welfare and Social Welfare. The study was conducted with prior permission from the concerned authorities. The study protocol was approved by the ethics committee of the J.S.S. Dental College and Hospital, Mysore. This field trial was conducted for 18 months from July 2004 to December 2005. Informed consent was obtained from the head of respective destitute homes.
Training and calibration
The investigator was trained in the Department of Community Dentistry, J.S.S. Dental College and Hospital on 20 subjects. Calibration was done on 20 subjects who were examined twice using diagnostic criteria on successive days, and then the results were compared to diagnostic variability. Agreement for assessment was 90 percent.
The examinations and treatment procedures were carried out in the respective destitute homes under natural light by the single investigator. The children were made to sit on a foldable chair.
To differentiate between active and inactive carious lesions, a caries diagnostic system differentiating between active and inactive carious lesions was used.6 The lesion was recorded, at cavitation level as active caries when enamel / dentin cavity was easily visible with the naked eye; surface of the cavity feels soft or leathery on probing. The lesion was recorded as inactive / arrested caries when the enamel or dentin cavity is easily visible with naked eye; surface of the cavity may be shiny and feels hard on probing with gentle pressure.
All teeth with cavitated active carious lesions were included for the study.
Teeth with frank or likely pulpal exposure, a history of pain, or the presence of a swelling or fistula were excluded.
Teeth that were at the period of shedding were excluded from the applications.
Teeth affected by fluorosis and enamel hypoplasia were excluded from the study.
Treatment group allocation
After baseline examination, considering inclusion and exclusion criteria, a list of 251 children with at least one active carious lesion was prepared assigning serial numbers to all the children in each destitute home. Then all the children who were assigned odd numbers were allocated to silver diamine fluoride group (I group) and the children who were assigned even numbers were allocated to sodium fluoride varnish group (II group).
For children in the first group, the soft surface in the carious lesions was carefully removed using hand instruments (excavators) without giving local anesthetic injections. Efforts were made to remove all the caries. Unsupported enamel was removed to render the cavity self cleansing. Soft dentin judged to be close to the pulp was left behind. The teeth were isolated using cotton rolls. The 38% silver diamine fluoride solution (Saforide®) was taken in a dappen dish. The disposable applicator brush was once dipped in the solution and then painted on the caries surface. This fluoride application was repeated at the end of one year.
For the children in the second group, the soft caries was carefully removed without giving local anesthetic injections. The 5% sodium fluoride varnish (Duraphat®) was taken in a dappen dish. The applicator brush was once dipped in the varnish and then painted on the cavity surface. The varnish application was repeated every 3 months till 15th month.
Control group was not considered in the field trial due to ethical reasons, as the caries preventive and arresting efficacy of fluoride has been already well established.
The follow up examinations were carried out at 6 monthly intervals for 18 months.
Data were then entered manually into the computer and SPSS version 10.0 (SPSS Pvt. Ltd., Chicago, IC, USA) was used for statistical analysis. Mean, Standard Deviation and independent t-test were used for the analyzing results. The statistical significance was fixed at P<0.05.
DROP-OUT RATE AMONG THE STUDY GROUPS
A total of 204 children attended all the applications and review examinations. The difference in subject drop-out rate between the groups was not statistically significant (Table 1). Reasons for drop-out were that the children were not available during the follow up examinations, some of them went in for restorative care and some of the children were advised for pulpal care.
TABLE 1 : Drop-out rate AMONG the study GROUPS
P = NS
Table 2: Distribution of study groups according to gender:
At 6 months mean number of arrested lesions was 1.96±1.21 for SDF group and it was 0.84±0.80 for SFV group. At 12 months mean number of arrested lesions was 1.50±1.16 for SDF group and it was 0.42±0.55 for SFV group. At 18 months mean number of arrested lesions was 1.67±1.24 for SDF group and it was 0.19±0.42 for SFV group. The difference was statistically significant (P<.001) (Table 3).
Out of the 204 active lesions in SDF group, 195 (95.6%) at 6 months, 149 (73%) at 12 months and 166 (81.37%) at 18 months had become arrested. Out of the 213 active lesions in SFV group, 67 (31.46%) at 6 months, 38 (17.84%) at 12 months and 15 (7%) lesions at 18 months had become arrested. (Table 4)
Table 3: MEAN NUMBER OF ARRESTED CARIOUS LESIONS AT 6 MONTHS, 12 MONTHS AND 18 MONTHS AMONG THE STUDY POPULATION
Mean number of active carious lesions at baseline ± SD
Mean number of arrested carious lesions at 6 months ± SD
Mean number of arrested carious lesions at 12 months ± SD
Mean number of arrested carious lesions at 18 months ± SD
< .49 (NS)
< .000 (HS)
< .000 (HS)
< .001 (HS)
Table 4: PROPORTION OF ARRESTED CARIOUS LESIONS AT BASELINE, 6 MONTHS, 12 MONTHS AND 18 MONTHS
Active lesions at baseline
Arrested lesions at 6 months
Arrested lesions at 12 months
Arrested lesions at 18 months
< .000 (HS)
< .000 (HS)
< .000 (HS)
Silver diamine fluoride (SDF) has been accepted as a therapeutic agent by the Central Pharmaceutical Council of the Ministry of Health and Welfare in Japan for dental treatment since the 1960s. A solution of 38% SDF was also used in China to arrest caries. It has been reported that there were a few dentists in Southern California who used SDF to arrest caries and harden the demineralized dentin of young children with early childhood caries. SDF in various concentrations has also been used in Argentina, Brazil and Spain. Community projects using SDF to arrest caries were planned for Cuba, Sub- Saharan Africa and in several African countries.
Duraphat, a 5% sodium fluoride (NaF) preparation, was the first commercially available fluoride varnish marketed by Woelm Pharma, Eschwege, Germany. Although fluoride varnishes have been widely used in many countries for decades, it was not until 1994 that the United States Food and Drug Administration (FDA) approved the use of fluoride varnishes in dentistry in the United States. It has been widely used in European countries since the 1980s. It is also widely used in the Middle East, Australia, New Zealand, and countries in Asia.
Effectiveness of silver diamine fluoride in arresting dental caries: The findings of the study are in agreement with the findings of previous studies by Craig GG et al (1981), Klien et al (1999), Llodra JC et al (2005) and Green E (1989).7,5,8,9
Effectiveness of sodium fluoride varnish in arresting dental caries: The findings of this study showed that 7% of the lesions were arrested at the end of 18 months where as in a study conducted by Modeer T et al (1984) showed that 38% of the proximal lesions in varnish group showed no progression at end of 3 years.10 This higher percentage of inactive lesions even at the end of 3 years may be because of the additional fluoride mouth rinse programme conducted fortnightly for the children in their study. A study conducted by Florio FM et al (2001) showed a higher percentage of inactive lesions in which 83.3% of the occlusal lesions in varnish group had become arrested at the end of 12 months.11 However, in their study other preventive programs such as weekly fluoride mouth rinse program and regular oral prophylaxis was also conducted for the study group whereas in our study no other preventive programs were conducted for the study group.
Comparison between the effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dental caries: In our study, it was found that annual applications of 38% silver diamine fluoride solution was more effective than the quartely applications of 5% sodium fluoride varnish. This finding is in agreement with previous study by Chu CH et al (2002).12 The caries arresting effectiveness of silver diamine fluoride may be explained on the basis of its mode of action. It has been reported that silver diamine fluoride reacts with the tooth mineral hydroxyapatite to release calcium fluoride and silver phosphate, which are responsible for the prevention and hardening of dental caries. The calcium fluoride formed provides a reservoir of fluoride for the formation of fluorapatite, which is more resistant to acid attack than hydroxyapatite. The silver phosphate that precipitates on the tooth surface is insoluble and it also has antibacterial properties.
The mean number of arrested lesions in SDF group reached the maximum at 6 months, a reduction at 12 months and then there was an again an increase at 18 months. Silver diamine fluoride was applied once in 12 months and that may be the reason for the decrease of number of arrested lesions at 12th month that is before reapplication and an increase at 18th month that is after reapplication of the solution at 12 months. No published studies are available regarding the frequency of SDF applications.
FEASIBILITY OF THE USE OF SILVER DIAMINE FLUORIDE IN COMMUNITY PROGRAMS FOR DISADVANTAGED POPULATION
Procedures are simple and it can be applied by the dental auxiliary personnel.
The procedure is non-invasive and thus the risk of spreading infection is very low.
The armamentarium is simple.
The time taken for the treatment is also less as painting of the lesion takes negligible time.
The child patient is also likely to have a good acceptance of the procedure.
The treatment is affordable.
However, the inherent disadvantage in using silver diamine fluoride to arrest caries is that the lesions were stained black. The SDF solution also has a metallic taste that is unpleasant.
Annual topical application of 38% silver diamine fluoride solution was more effective in arresting dental caries when compared to quarterly topical applications of 5% sodium fluoride varnish in arresting dental caries among the children aged 6-15 years.
For the underprivileged population, with little developed infrastructure an outreach service using simple armamentarium such as that required for SDF therapy would be a viable means of providing cost effective care.
SUGGESTIONS AND RECOMMENDATIONS
The caries arresting technique using silver diamine fluoride can be provided to the community along with health educational activities, plaque control and other preventive and oral health promotional activities.
As a community measure, public health dentists can take advantages of SDF to control dental decay of children especially for those in disadvantaged communities.
It is an attractive agent in the management of caries in young and uncooperative children. It can also be used in medically compromised patients.
For deciduous dentition, caries arresting technique using SDF can be applied to control caries progression so that the primary teeth can be saved and maintain the space needed for their succeeding permanent teeth to erupt.
For permanent dentition, this caries arresting technique using SDF can be applied to halt the caries progression until an interventional programme for restoring these carious lesions using Atraumatic Restorative Treatment.
Further studies can be carried out to study the frequency of SDF application on the effectiveness in arresting caries in children. From the findings of our study, it can be recommended that semiannual applications of SDF would be more beneficial as the maximum number of arrested lesions was found at 6 months.
Further studies can be performed to assess the effect of varying the concentration like dilution of the SDF solution in arresting dental caries.
Further studies can also be conducted to study its effectiveness in arresting root caries.
Furthermore, SDF may enhance the success rate of ART because good pulpal response to preconditioning with SDF before the provision of Atraumatic restoration with a GIC has been reported. More clinical trials are necessary in this aspect.
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