Materials Reactivity Testing Clifford Consulting Research Inc Prepared

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Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13

Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13 -14 November 2004 London

The Nature Of The Problem. . Shaping New Dental Thought With Science “The safety

The Nature Of The Problem. . Shaping New Dental Thought With Science “The safety of dental materials has historically been assumed. Indeed, many materials have been classified by the FDA as ‘nonsignificant risk devices’. The testing is often superficial, with most interest directed toward physical performance of the material. When a biological response is considered, the reaction anticipated is usually acute toxicity. ” Schultz, et. al. , Oral Health, page 7, 1997

How Materials Are Usually Selected. . Shaping New Dental Thought With Science ● ●

How Materials Are Usually Selected. . Shaping New Dental Thought With Science ● ● ● ● Will it stay put and wear well? Is it hard or time-consuming to use? Does it make the mouth sore? Does it look good? Has the ADA approved it? Who else is using it? How expensive is it?

About Thresholds. . Shaping New Dental Thought With Science ● ● ● Reactivity requires

About Thresholds. . Shaping New Dental Thought With Science ● ● ● Reactivity requires acquisition of one or more thresholds Compensatory mechanisms may mask some reactivities Symptoms and loss of function do not follow a linear pathway Reducing body burden may permit limited use of toxics Sporadic symptoms may indicate loads at threshold boundary

How Do Reactivity Issues Arise? Shaping New Dental Thought With Science ● ● ●

How Do Reactivity Issues Arise? Shaping New Dental Thought With Science ● ● ● ● Corrosion by-products Out gassing and off-loading Improper mixing Incomplete curing Dissimilarity in alloys and mixed etiologies Diet Microbial presence

Corrosion Activity And Absorption Shaping New Dental Thought With Science ● ● ● Corrosive

Corrosion Activity And Absorption Shaping New Dental Thought With Science ● ● ● Corrosive effects of p. H and osmolality Disruption of normal osmotic gradient Available binding sites and physiology modification Entrance through both soft and hard tissues Dissimilarity throughout the oral cavity

Tissue-Based Conversions Shaping New Dental Thought With Science ● ● ● Oral cavity fluids

Tissue-Based Conversions Shaping New Dental Thought With Science ● ● ● Oral cavity fluids Periodontal violations Cellular secretions and modifications Blood Mucous membranes Physical swallowing

Microbial Conversions Shaping New Dental Thought With Science ● ● ● Direct microbial physiology

Microbial Conversions Shaping New Dental Thought With Science ● ● ● Direct microbial physiology Microbial waste products Altered physiology Competitive binding of nutrients Mixed microbial etiology Contribution of gut flora

Galvanic Generation Shaping New Dental Thought With Science ● ● ● ● Dissimilar alloys

Galvanic Generation Shaping New Dental Thought With Science ● ● ● ● Dissimilar alloys and other components Local circuits within a restorative mass Circuits within the same tooth and between adjacent teeth Long-range circuits throughout the body Chemistry alterations due to p. H, osmolality, and microbes Electron sumping via the vascular bed Tissue violation due to burns and necrosis Electromotive table

Mechanical Irritation Shaping New Dental Thought With Science ● ● Surface violations due to

Mechanical Irritation Shaping New Dental Thought With Science ● ● Surface violations due to friction and pressure Interference with circulatory activity Direct blood contact Chemotactic and electro tactic attraction of leucocytes

Adjuvant Amplified Actions Shaping New Dental Thought With Science ● ● Increased irritability of

Adjuvant Amplified Actions Shaping New Dental Thought With Science ● ● Increased irritability of weak antigens Piggy-backed reactions with established allergens Mixed microbial synergism and altered terrain Abnormal attraction of leucocytic action

Physical Symptomology Of Reactivity Shaping New Dental Thought With Science ● ● ● ●

Physical Symptomology Of Reactivity Shaping New Dental Thought With Science ● ● ● ● Discolorations and tattoos Mechanical site irritations Infection patterns - perio Tremor and motor control problems Sweats and abnormal temperature excursions Numbness, tingling and asymmetric muscle and sensory control Increasing unexplained fatigue

Physical Symptomology Of Reactivity Shaping New Dental Thought With Science ● ● ● ●

Physical Symptomology Of Reactivity Shaping New Dental Thought With Science ● ● ● ● Chronic gastrointestinal and digestive problems Bowel dysfunction and unexplained eliminatory excursions Persistent unusual taste sensations Sudden frequent urination Persistent headache and regional neuralgia Sleep pattern disturbances Itching, tight or irritated skin

Physical Symptomology Of Reactivity Shaping New Dental Thought With Science ● ● ● ●

Physical Symptomology Of Reactivity Shaping New Dental Thought With Science ● ● ● ● Upper torso regional angina and chest pain Severe excursion of irritability and mood Frequent non-focused depression Decreasing cognitive function Frequent severe tinitis Frequent irrational fear Bruxing

Clinical Detection Of Reactivity Shaping New Dental Thought With Science ● ● ● ●

Clinical Detection Of Reactivity Shaping New Dental Thought With Science ● ● ● ● General physical symptoms in the surrounding tissues Specific antibodies to restorative components Leucocyte counts <5000 and >7000 Depressed oxygen saturation via co-oximetry Increased hemoglobin subspecies (met-, sulf- and carboxy-) Triglyceride elevation with relatively normal cholesterol Moderate hypoglycemia (60 -70 mg/dl)

Clinical Detection of Reactivity Shaping New Dental Thought With Science ● ● ● ●

Clinical Detection of Reactivity Shaping New Dental Thought With Science ● ● ● ● Irregular BUN and uric acid Abnormal LDH subspecies Creatinine clearance impairment Non-responsive chronic infections Marked blood pressure excursions Marked pulse variations Endocrine dysfunction

Approaches To Reactivity Detection Shaping New Dental Thought With Science ● ● ● Review

Approaches To Reactivity Detection Shaping New Dental Thought With Science ● ● ● Review of patient history and questionnaire Patch, pellet and injection provocative challenges Inhalation and sublingual challenges Electro dermal evaluation Kiniesiologic determination

Approaches To Reactivity Detection Shaping New Dental Thought With Science ● ● ● Active

Approaches To Reactivity Detection Shaping New Dental Thought With Science ● ● ● Active challenge of lymphocytes (ELISA, MELISA, viability) Apoptosis challenges Necrosis evaluation Cytotoxic testing Passive specific antibody detection

Strengths In Antibody Detection Methods Shaping New Dental Thought With Science ● ● ●

Strengths In Antibody Detection Methods Shaping New Dental Thought With Science ● ● ● ● Detectable even after toxic substance exits the body Repeatable and demonstrable Classical laboratory methodology Irritant concentration independent Irritant source independent Findings have broad-spectrum applicability Specimen is storable when necessary

Weaknesses Of Antibody Detection Method Shaping New Dental Thought With Science ● ● ●

Weaknesses Of Antibody Detection Method Shaping New Dental Thought With Science ● ● ● Qualitative findings only No degree-of-reactivity data Cross-reactions possible False positives False negatives Reduced value with universal reactors

Antibody Data Application Shaping New Dental Thought With Science ● ● ● Antibody reaction

Antibody Data Application Shaping New Dental Thought With Science ● ● ● Antibody reaction for entire chemical group or family One set of findings applicable to many products After-the-fact evaluations Irritant source independent Useful beyond simple dental materials screening

Who Should Consider Being Tested. . Shaping New Dental Thought With Science ● ●

Who Should Consider Being Tested. . Shaping New Dental Thought With Science ● ● ● ● Patients with known materials-related problems Immunocompromised and autoimmune-positive patients Endocrine, hepatic and renal compromised patients Severe allergy patients Universal reactor / environmentally ill patients High cost, complex restoration projects Galvanically active patients Patients seeking peace of mind

Blood Drawing

Blood Drawing

Shipment Of Specimen

Shipment Of Specimen

Test Tray Preparation

Test Tray Preparation

Patient Specimen Dispensing

Patient Specimen Dispensing

Data Processing And Reporting

Data Processing And Reporting

Test Reporting

Test Reporting

Getting Materials Into The System Shaping New Dental Thought With Science ● ● ●

Getting Materials Into The System Shaping New Dental Thought With Science ● ● ● MSDS and Product Insert Sheet Research / Technical department at the manufacturer 510 -K filing data with the US FDA / European equivalents Research literature Dental product databases sponsored by associations Physical testing

And While We’re At It. . . Shaping New Dental Thought With Science ●

And While We’re At It. . . Shaping New Dental Thought With Science ● ● ● Metal-free dentistry Aluminum in restoratives Gutta percha Estrogen mimicry Non-precious alloys How much metal is required to be a factor

Metal-Free Dentistry Shaping New Dental Thought With Science ● Basic chemistry requires that anions

Metal-Free Dentistry Shaping New Dental Thought With Science ● Basic chemistry requires that anions be balanced with cations ● Nearly all cations are metals ● Issue of Content vs. Form ● Dissociability / Ionizability ● Binding to ligands, amino acids, proteins, polysaccharides and adipose tissues ● Some metals accumulate, others readily pass on

Aluminum In Restoratives Shaping New Dental Thought With Science ● Aluminosilicate, alumina and aluminum

Aluminum In Restoratives Shaping New Dental Thought With Science ● Aluminosilicate, alumina and aluminum oxide have half-life on the order of 109 - 1011 years under oral cavity conditions ● Forms found in glass and sand ● Human skeleton is 2. 0% - 2. 5% Aluminosilicate, normally, naturally and routinely ● Sometimes disguised as ‘quartz’, ‘mica’ or ‘feldspar’ ● Dissociable aluminum is a grave cause for concern

Gutta Percha Shaping New Dental Thought With Science ● Common vs. Synthetic / Purified

Gutta Percha Shaping New Dental Thought With Science ● Common vs. Synthetic / Purified ● Gutta percha sold and marketed through reputable North American and West European supply sources within the past 1520 years is of the synthetic or semi-synthetic or purified variety ● Cheap dentistry is cheap for a reason

Estrogen Mimicry Shaping New Dental Thought With Science ● Bis-Phenol-A and certain other organic

Estrogen Mimicry Shaping New Dental Thought With Science ● Bis-Phenol-A and certain other organic compounds can mimic the binding qualities and stimulatory functions of estrogen, and may be carcinogenic ● Uncured or incompletely cured monomer may be an issue ● Component mixing needs to be carefully executed ● Do not take short cuts with curing process ● Cleanliness is next to Godliness

Non-Precious Alloys Shaping New Dental Thought With Science ● Nickel is wonderful in structural

Non-Precious Alloys Shaping New Dental Thought With Science ● Nickel is wonderful in structural steel and certain stainless applications - Keep it out of the body and in the building ● Chromium in the penta- or hexa-valent state is a disaster ● Cadmium will do anything mercury, arsenic and lead can do it’s just a little slower ● Hiding metal alloy under porcelain or ceramic is about as isolating as coating mercury with saliva ● NEVER, NEVER USE MERCURY AND GOLD IN THE SAME MOUTH - Never!

The Future. . .

The Future. . .