Medical management of Dental Caries

Transcription

1 Medical management of Dental Caries 2016 Governor s Conference on Aging & Disability Dr. Arwa Owais 05/23/2016

2 Managing Carious Lesions (2016) Advances in Dental Research: 2016, Vol. 28(2) 58 67

3 Goals and Objectives: The concept of Medical Management of Caries Historical Perspective of Silver compounds Available evidence of effectiveness SN of SDF Mechanism of Action of silver compounds in arresting caries. Biocompatibility, adverse effects and safety Clinical Procedures, codes and Consent

4 Background Requirements for the management of caries has been changing over time. Growing evidence for minimally invasive approaches to arrest caries Proposed modalities for treatment of carious lesions: pit and fissure sealants, resin infiltration, xylitol, chlorhexidine, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and ozone therapy, SILVER Lack of strong scientific evidence for clinically-effective non-surgical caries management in dentition

5 Clinical Scenario

6 Clinical Scenario

7 Clinical Scenario

8 Clinical Scenario

9 Silver Compounds- Review of the Literature

10 Silver Nitrate

11 Silver Nitrate Silver nitrate at a Glance: 1800s -2015

12 Stebbins, 1891 Teeth restored with amalgam displayed black surfaces where the progress of decay had ceased. Nitric acid was mixed with amalgam scraps and applied to caries lesions in 35 children. Caries inhibition was the result of bacterial killing and the deposition of a black crust, generating a sclerotic protective coating of secondary dentin.

13 Prior to 1890s, Debate on the carious process whether it is: Inflammation coming from the inside of the tooth Bacterial infection occurring on the outside of the tooth

14 W. D. Miller 1890s Scientific Pioneer of Dentistry ( ) Between 1881 & 1907: 164 scientific articles were published Few books: Die Mikroorganismen der Mundhohle The Micro-Organisms of the Human Mouth Was able to identify that tooth decay is caused by BACTERIAL INFECTION The second most potent agent that kills oral microorganisms is silver nitrate

15 GV Black, 1906 The idea that dental purely mechanical and not dependent upon knowledge of the pathology of dental caries, should be abandoned forever. Surgical model was incomplete! Used silver nitrate to arrest caries over 100 years ago introducing the medical management model

16 GV Black Protocol of Silver Nitrate Leave the decayed material in the dentin where it is, if some decay is left or some dentin is exposed, it should be treated with silver nitrate. First lay a crystal of silver nitrate on a glass slab and crush it. Have some water and an orangewood stick cut to a point ready Put a single small drop of water on the crushed crystal and make as nearly a saturated solution as possible.

17 G.V. Black SN a 100 years ago

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19 Silver Nitrate- a 100 years apart

20 1920s: Percy Howe

21 Howe s JADA 1922

22 Mechanism of Action of SN Interaction with the tooth structure Effect on bacteria

23 Reactioon of SN with the tooth structure

24 SDF Reactions

25 Mechanism of Action

26 Effect of SN on Bacteria

27 FDA Regulation of SN Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. (USFDA, 1998; AAP, 2002)

28 Silver Nitrate- Product Information

29 Steve Duffins Protocol

30 Steve Duffins Protocol

31 SN application

32 Silver Diamine Fluoride (SDF)

33 FDA Clearance In August 2014 the Food and Drug Administration (FDA) cleared the first silver diamine fluoride product for market. April 2015, the product is available.

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35 Legal considerations Cleared by the FDA for marketing as a Class II medical device to treat tooth sensitivity. Off label use as a drug to treat and prevent dental caries. Parallel situation to fluoride varnish

36 Silver Diamine Fluoride as a Material Silver diamine fluoride (38% w/v Ag(NH 3 ) 2 F, 30% w/w) A colorless topical agent comprised of % (w/v) silver and % fluoride ph 10 Marketed as Advantage Arrest TM by Elevate Oral Care, LLC (West Palm Beach, FL).

37 Is Silver Diamine Fluoride Solution Legally Manufactured in the US?

38 SDF- Indications Extreme caries risk/ Severe ECC Inability to treat due to medical or behavioral reasons. Extent of dental caries to be treated in one or few sessions. Difficult to treat carious lesions, e.g. crown margins, furcation area, etc. Patients without access to dental care.

39 SDF- Literature Arrested Caries Prevented Caries

40 38% SDF solution Antibacterial When in contact with dentin: Ag 3 PO 4 (weakly soluble; turns black with sunlight or reducing agents)= Black, hard layer Metallic taste; transient gingival and mucosal irritation (Liorda et al., 2005) To encounter stain: KI (no clinical trial; in vitro suggests same effect on biofilm) Low cost, easy to use Arrest caries in primary teeth of preschool children

41 38% SDF solution Used on cavitated lesions No need for prior excavation (1x/year: PF ~ 70-84%; better than FV ~ 44-56%) 2x/ year better than nothing in prevention and arrest (primary teeth PF 79% and 64% in permanent teeth) 38% more effective than 12% SDF Equally effective to FV and sealant on sound/ non-cavitated 1 st permanent molars SDF-KI ( washed) creates bond strengths no different than conditioned samples prior to GI application.

42 SDF- Recommendations from the literature 38% silver diamine fluoride is effective and efficient in arresting and preventing carious lesions. Application only to lesions appears to be similarly effective in preventing cavities in other teeth and surfaces as applying directly Single application appears insufficient for sustained effects, while annual reapplication results in remarkable success, and even greater effects with semi-annual application.

43 SDF- Recommendations from the literature 38% silver diamine fluoride is effective and efficient in arresting and preventing carious lesions. Application only to lesions appears to be similarly effective in preventing cavities in other teeth and surfaces as applying directly Single application appears insufficient for sustained effects, while annual reapplication results in remarkable success, and even greater effects with semi-annual application.

44 Efficacy of SN, SDF compared to CHX and F- Klein et al, 1999

45 Silver Documentation and Billing D1354, for "interim caries arresting medication application" was approved by the Code on Dental Procedures and Nomenclature (CDT) Code Maintenance Commission for Code is effective January 1, 2016 Code definition = "Conservative treatment of an active, non-symptomatic carious lesion by topical application of a caries arresting or inhibiting medicament and without mechanical removal of sound tooth structure".

46 Consent What should be included? Expected change in color of the demineralized enamel and dentin as the decay arrests Likelihood of reapplication, and Contraindications in the presence of silver allergy and stomatitis.

47 Consent Forms: UCSF Advantage Dental Clinics Oral Health Outreach

48 SDF- Effects on bonding SDF had no effect on composite bonding to noncarious dentin using either self-etch or full etch systems. Inconsistent results regarding the bonding to GIC. Rinsing may be a solution to increase the bond strength.

49 SDF- Safety Average LD50 by oral administration was 520 mg/kg (rat studies) Average LD50 by subcutaneous administration was 380 mg/kg One drop Scenario: (25 μl) is ample material to treat 5 teeth Contains 9.5 mg silver diamine fluoride. Assuming the smallest child with caries would be in the range of 10 kg, the dose would be 0.95 mg / kg child. Thus the relative safety margin of using an entire drop on a 10kg child is: 380 mg/kg LD50 / 0.95 mg / kg dose = 400-fold safety margin. Recommended limit as 1 drop (25 μl) per 10 kg per treatment visit, with weekly intervals at most

50 Cumulative exposure- Argyria The Environmental Protection Agency set the lifetime exposure conservatively at 1 gram to safely avoid Argyria. An irreversible discoloration of the pigment (skin) caused by excessive silver intake or chronic exposure to silver by certain tissues. The amount of silver required to develop Argyria is estimated to be 3.8 grams per day

51 SDF- Medical Adverse effects Not a single adverse event has been reported to the Japanese authorities since they approved silver diamine fluoride (Saforide, Toyo Seiyaku Kasei Co. Ltd., Osaka, JP) over 80 years ago. 9 RCTs in which SDF was applied: 3 of 1,493 children or elders experienced a small, mildly painful white lesion in the mucosa, which disappeared at 48 hours without treatment. No adverse pulpal response was observed. Gingival responses have been minimal: no erythema, bleeding, white changes, ulceration, or pigmentation was found after 24 hours. no evidence of fluorosis resulting from long-term proper use of SDF.

52 SDF- Non medical adverse effects Darkens carious lesions? Is it an adverse effect or a sign for caries arrest? Transient metallic or bitter taste Stains clinic surfaces and clothes. Be careful! Spills can be cleaned with water, ethanol, or bleach(?). Ammonia may be more successful.

53 The Use of Potassium Iodide (SSKI ) Application of a saturated solution of potassium iodide (SSKI) immediately following silver diamine fluoride treatment is thought to decrease staining SSKI maintained caries arrest efficacy in the early results of an ongoing clinical trial. SSKI is contraindicated in pregnant women and during the first six months of breastfeeding due to concern of overloading the developing thyroid with iodide; thyroid specialists suggested a pregnancy test prior to use in women of childbearing age uncertain of their status.

54 How to handle SN and SDF in the Clinic

55 Pan set up Silver nitrate/ Silver diamine fluoride solution Dapen dish Microbrush Fluoride varnish, extra brush Soft-pick Micropippete

56 One drop Only will do the Job

57 Amish Silver Nitrate Clinical Trial: Study Design and Subject Recruitment

58 Research Team Members Dr. Arwa Owais Co-PI Dr. Karin Weber-Gasparoni Dr. Alberto Gasparoni Dr. John Warren Deborah Dawson, PhD George Wehby, PhD Mary Akers Dr. Mike Kanellis David Drake, PhD Dr. Matt Geneser Wei Liu, M.P.H. Dr. Reem Oweis Cathy Skotowski, M.S Dental Students

59 Funding Delta Dental of Iowa Foundation Dow s Institute for Dental Research Department of Pediatric Dentistry

60 Purpose of the Study To compare the conventional approach of restoring caries in the primary dentition, to medically managing caries using silver nitrate and fluoride varnish.

61 Study Population Amish children living in Kalona, IA. Settlement established 1845 Ave. family has 8 children High caries rate Low exposure to fluoride Limited access and utilization of regular dental care

62 Study Design Randomized controlled clinical trial. Inclusion Criteria: Healthy children (2-11 years of age) with at least one primary tooth with caries into dentine. Random assignment to one of two groups: Conventional restorative group Silver nitrate / fluoride varnish group Subjects to be followed for a minimum of two years

63 Current Progress of the Study Oct, 2014 IRB approval ( ) Oct & Nov, 2014 Informational sessions Nov, May, 2015 Recruitment, enrollment, random assignment, treatment July, 2015 Recalls began

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65 Next Steps Would like to have 90 children enrolled in study Continue to follow Analyze data

66 Questions?