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

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Page 1: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London
Page 2: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Materials Reactivity Testing

Clifford Consulting & Research, Inc.

Prepared for The IAOMT-UK Seminar13-14 November 2004London

Page 3: 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 of dental materials has historically been assumed. Indeed, many materials have been classified by the FDA as ‘non- significant 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

Page 4: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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?

Page 5: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 6: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 7: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Corrosion Activity And Absorption

Shaping New Dental Thought With Science

●Corrosive effects of pH 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

Page 8: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Tissue-Based Conversions

Shaping New Dental Thought With Science

●Oral cavity fluids●Periodontal violations●Cellular secretions and modifications●Blood●Mucous membranes●Physical swallowing

Page 9: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 10: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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 pH, osmolality, and

microbes●Electron sumping via the vascular bed●Tissue violation due to burns and necrosis●Electromotive table

Page 11: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 12: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

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

Physical Symptomology Of ReactivityShaping 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

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

Physical Symptomology Of ReactivityShaping 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

Page 15: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Physical Symptomology Of ReactivityShaping 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

Page 16: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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)

Page 17: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 18: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Approaches To Reactivity DetectionShaping 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

Page 19: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Approaches To Reactivity DetectionShaping New Dental Thought With Science

●Active challenge of lymphocytes (ELISA, MELISA, viability)

●Apoptosis challenges●Necrosis evaluation●Cytotoxic testing●Passive specific antibody detection

Page 20: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Strengths In Antibody Detection MethodsShaping 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

Page 21: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Weaknesses Of Antibody Detection MethodShaping 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

Page 22: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 23: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 24: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Blood Drawing

Page 25: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Shipment Of Specimen

Page 26: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Test Tray Preparation

Page 27: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Patient Specimen Dispensing

Page 28: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Data Processing And Reporting

Page 29: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

Test Reporting

Page 30: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 31: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 32: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 33: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 34: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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 15- 20 years is of the synthetic or semi-synthetic or purified variety

●Cheap dentistry is cheap for a reason

Page 35: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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

Page 36: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

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, NEVER USE MERCURY AND GOLD IN THE SAME MOUTH - Never!

Page 37: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London

The Future...

Page 38: Materials Reactivity Testing Clifford Consulting & Research, Inc. Prepared for The IAOMT-UK Seminar 13-14 November 2004 London