CLINICAL EVALUATION AND COMPARISON OF SILVER DIAMINE FLUORIDE AS A CARIES ARRESTING AGENT IN PRIMARY TEETH
BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR STUDY
Dental caries is one of the most prevalent chronic diseases affecting children and adults across the globe that can be both treated and prevented1. There is a transition towards minimally invasive restorative techniques in restorative dentistry based upon reducing bacterial viability and encouraging remineralization of caries infected tissue. Glass ionomer cements,varnishes, resin modified glass ionomer cements and compomers are available with varying quantities of fluoride and fluoride release rates as well as different
clinical success values2 Silver diamine fluoride (SDF) has also been used as a cariostatic agent3. Application of silver diamine fluoride is simple and non invasive. SDF helps in the deposition of silver phosphate to restore mineral content, resulting in rehardening of tooth structure. It also releases fluoride. Cariostatic action is obtained by the stimulation of dentin sclerosis, not allowing the progress of dental decay 4,5. Antimicrobial action is due to its action over Streptococcus Mutans6.
Glass ionomer has also been used as a material for placement of dental restorations and is known to release fluoride, which can help to remineralize the carious lesion7. There are not many invivo studies to compare the caries arresting property of different concentrations of silver diamine fluoride and glass ionomer. This study aims to compare the effect of silver diamine fluoride (at different concentrations) and glass ionomer in arresting dentine caries in primary teeth.
6.2 REVIEW OF LITERATURE
1. A prospective controlled clinical trial was conducted on the efficacy of 38% SDF solution for caries reduction. Four hundred and twenty-five six-year-old children were divided into two groups: One group received SDF solution in primary canines and molars and first permanent molars every 6 months for 36 months. The second group served as controls. The 36-month follow-up was done on 373 children. The mean number of new decayed surfaces appearing in primary teeth during the study was 0.29 in the SDF group vs. 1.43 in controls. The mean of new decayed surfaces in first permanent molars was 0.37 in the SDF group vs. 1.06 in controls. The study concluded that SDF solution is effective for caries reduction in primary teeth and first permanent molars 3.
2. Randomized clinical trial was done on 976 Nepalese schoolchildren to investigate the caries-arresting effectiveness of a
(1) 38% silver diamine fluoride (SDF) with tannic acid as a reducing agent
(2) 38% SDF alone
(3) 12% SDF alone and
(4) Control group with no application
At 6, 12, and 24 months, the mean number of arrested carious surfaces was significantly higher in the two groups treated with 38% SDF than in the 12% SDF and control groups. The difference observed at 6 months decreased over 24 months, but remained statistically significant. There was no significant difference in the mean number of arrested carious surfaces between the 38% SDF and the 38% SDF + tannic acid groups, or between the 12% SDF and the control groups throughout the 24-month study period. There was also no significant difference between the groups in the mean number of non-vital teeth and the mean number of exfoliated surfaces at any time.4
3. Glass ionomer and silver diamine fluoride were evaluated and compared to calcium hydroxide for their anti microbial efficacy and re-mineralizing potential. Dentin disks prepared from 45 freshly extracted first premolars were divided into three groups (n = 15). Each disk was cut into two equal parts, in which one half formed the control. Thirty dentin samples were used for ion estimation and the other 15 for microhardness testing. Atomic absorption spectrophotometry, colorimetric and potentiometric titration analyses were performed for calcium, phosphate and fluoride ion detection, respectively. The antimicrobial efficacy was analyzed using pure culture of Streptococcus mutans and mixed flora.The results of mineral content analysis in this study indicate that almost equivalent rise in the percentage of calcium ions was seen in GC VII and Ca(OH)2 group, followed by SDF group. Highest percentage of rise in phosphate ions was seen in GC VII group followed by SDF and Ca(OH)2 groups. Highest increase in fluoride ions was seen in GC VII, followed by SDF and Ca(OH)2 groups. The results indicated that both GC VII and SDF can be used as potential substitutes to Ca(OH)2 for indirect pulp capping. 5 4. Thirty-two artificially demineralized human dentine blocks were equally divided with S. mutans and A. naeslundii. Either SDF or water was applied to eight blocks in each group. Biofilm morphology, microbial kinetics and viability were evaluated by scanning electron microscopy, colony forming units, and confocal microscopy. The cross section of the dentine carious lesions were assessed by microhardness testing, scanning electron microscopy with energy-dispersive x-ray spectroscopy and Fourier transform infrared spectroscopy. Biofilm counts were reduced in SDF group than control. Surfaces of carious lesions were harder after SDF application than after water application, in S. mutans group, Ca and P weight percentage after SDF application than after water application. Lesions showed a significantly reduced level of matrix to phosphate after SDF treatment. Study showed that SDF posses an anti-microbial activity against cariogenic biofilm of S. mutans or A. naeslundii formed on dentine surfaces. SDF slowed down demineralization of dentin6.
5. A study was done to compare the effectiveness of annual topical application of silver diamine fluoride (SDF) solution, semi-annual topical application of SDF solution, and annual applicationof a flowable high fluoride-releasing glass ionomer in arresting active dentine caries in primary teeth. A total of 212 children, aged 3–4 years, were randomly allocated to one of three groups for treatment of carious dentine cavities in their primary teeth: Gp1-annual application of SDF, Gp2-semi-annual application of SDF, and Gp3-annual application of glass ionomer. Follow-up examinations were carried out every six months to assess whether the treated caries lesions had become arrested. After 24 months, 181 (85%) children remained in the study. The caries arrest rates were 79%, 91% and 82% for Gp1, Gp2 and Gp3, respectively ( p =0.007).Annual application of either SDF solution or high fluoride-releasing glass ionomer can arrest active dentine caries. Increasing the frequency of application to every 6 months can increase the caries arrest rate of SDF application7.
6.3 OBJECTIVES OF THE STUDY
Clinical and microbiological evaluation of 38% silver diamine fluoride as a caries arresting agent in primary teeth.
Clinical and microbiological evaluation of 12% silver diamine fluoride as a caries arresting agent in primary teeth.
Clinical and microbiological evaluation of low viscosity high fluoride releasing glass ionomer as a caries arresting agent in primary teeth.
Clinical and microbiological evaluation & comparison of 38% and 12% of silver diamine fluoride and low viscosity high fluoride releasing glass ionomer as a caries arresting agent in primary teeth.
The study will be conducted on 75 primary molar teeth in patients aged between 5-9 years of age visiting the Department of Pedodontics and Preventive Dentistry at A.E.C.S Maaruti College of Dental Sciences and Research Center, Bangalore.
A study performa will be designed which will include demographic details, chief complaint and recording of all the subjective and objective symptoms, radiographic findings and the follow-up recordings.
1. Healthy cooperative children of 5-9 years
2. No history of spontaneous pain
3. Distinct occlusal cavity with visible dentin (ICDAS II code 5)
4. Children with prior parent consent.
5. Teeth with atleast 2/3rd root present.
1. History of pain
2. Pain on percussion or palpation
3. Presence of swelling/fistula near the carious tooth
19. Aerotor and Contra angled Micromotor hand piece
20. Finishing burs
Ninety (90) primary molar teeth will be selected by using the inclusion and exclusion criteria. Only occlusal surface of the primary molar teeth will be considered for the study. Status of the dentinal caries lesions will be assessed by visual inspection and aided by tactile detection using a sharp probe. Cavities with yellowish /brown rough wall or floor which can be easily penetrated by probe using a light force will be diagnosed as active.
Those with smooth hard surfaces which can not be penetrated will be classified as arrested. After thorough oral prophylaxis of both upper and lower arches isolation will be done using cotton roll .The first sample for microbial analysis will be collected with a sterile excavator from the center of demineralized lesion before starting the removal of caries and will be immediately transfer to the lab for culture.
The samples taken will be inoculated on to MS agar and Rogosa SL agar for selective isolation of Streptococcus mutans and Lactobacilli respectively. Total Viable Count (TVC) for all cultivable bacteria will be done. Microbial culture will be done aerobically and anaerobically and Colony Forming Unit counting will be calculated
Dentin excavation will be accomplished in circular scratching movements from the dentinoenamel junction to the cavity floor, using #5 or #18 spoon excavators according to the lesion size. Excavation will be completed when dentin at the cavity floor become resistant to probing, following the clinical criteria of hard texture.
Teeth selected will be randomly divided into 3 groups of 25 each.
GROUP 1: After drying the teeth with a cotton pellet, one drop of 38 % silver diamine fluoride will be taken in a plastic dappen dish and will be applied with a Viva brush applicator for 2 minutes
GROUP 2: Teeth that will be painted with silver diamine fluoride 12% following the same procedure of group 1.
GROUP 3: The cavity surfaces will be pre conditioned with the Fuji VII GC conditioner, and then it will be washed with a wet cotton pellet and will be allowed for drying. Then it will be painted with a low viscosity high fluoride releasing glass ionomer material (Fuji VII,GC corporation Japan) with vivabrush applicator. GC varnish will be applied as a protective coating.
All the three groups will be restored with reinforced zinc oxide eugenol (IRM® Dentsply). The children will be instructed not to eat or drink for atleast 1 hour.
The patients will be recalled after a period of 6 months for evaluation of the caries arresting property of different materials.
The restorative material will be removed first using smooth round burs at low speed and then using sterile excavator. A sample of dentin from the pulpal wall of the cavity just below the restoration will be taken under sterile conditions and will be immediately transferred to the laboratory for the microbiological evaluation for streptococcus mutans and lactobacilli.
Arrested caries will be restored with highly viscous condensable glass ionomer cement (Fuji IX). In case of caries progression the necessary treatment will be done accordingly.
The results will be tabulated and subjected to statistical analysis.
7.3 Does the study require any investigation or interventions to be conducted on patients or other human or animals? If so, please describe briefly.
Radiograph will be taken during the study.
7.4 Has the ethical clearance been obtained from your institution?
1. Alice Chen, Mary Cho, Sari Kichler, Jeffrey Lam, Anum Liaque, Sobia Sultan. Silver diamine fluoride: An alternative to topical fluorides. JCDA 2012 April;XX(X):1-14.
2. Arends J, Dijkman GE and Dijkman AG . Review of fluoride release and secondary caries reduction by fluoridating composites. Adv Dent Res 1995 9: 367 – 370.
3. Llodra JC, Rodriguez A, FerrerB, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molar of schoolchildren:36-month clinical trial J Dent Res 2005 84(8):721-724.
4. Yee R, Holmgren C, Mulder J, Lama D, Walker D, Palenstein Helderman W. Efficacy of silver diamine fluoride for arresting caries treatment. J Dent Res 2009 88(7):644-647.
5. Gupta A, Sinha N, Logani A, Shah N. An ex vivo study to evaluate the remineralizing and antimicrobial efficacy of silver diamine fluoride and glass ionomer cement type VII for their proposed use as indirect pulp capping materials – Part I. J Conserv Dent. 2011 Apr-Jun;14(2): 113–116
6. Chun Hung Chu,Lei Mei, Seneviratne CJ, Man Lo EC. Effects of silver diamine fluoride on dentin carious lesions induced by streptococcus mutans and actinomyces naeslundii biofilm. International Journal of Paediatric Dentistry 2012 Jan;22(1):2–10.
7. Zhi QH, Chin Man Lo E , Lin HC. Randomized clinical trial on effectiveness of silver diamine fluoride and glass ionomer in arresting dentine caries in preschool children Journal Of Dentistry.2012:(40):962-967.
Department of Pedodontics and Preventive Dentistry CONSENT FORM
I -------------------------------------- (name of the parent) hereby give my consent
to include my child ----------------------------------------------for the study being
conducted by Dr .Geetha C P, PG Student, Department Of Pedodontics and Preventive Dentistry, AECS Maaruti College of Dental Sciences and Research Center, Bangalore.
The above treatment procedure performed in the 6 months study has been explained to me.
Signature of Parent: Staff Signature: Address:
ANNEXURE 1 PROFORMA
Patient’s name : Case No: Age : Date : Sex : O.P.No: Father’s Name : Occupation : Address : Telephone No. : Significant Medical History : Past Dental History : Personal History : Chief Compliant : History of Presenting Illness: