biological aspects of - jokstad lecture safety biology sso... · 2018-02-02 · schuurs et al.,...
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Biological aspects of dental restorations
with composites
Asbjørn JokstadInstitute of Clinical Dentistry
University of Oslo, Norway
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http://www.odont.uio.no/prosthodont/sso
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SSO Lausanne 15.06.2001
Any reasons
for biological concern?
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SSO Lausanne 15.06.2001
Standard Screening Tests for Biocompatibility; ISO, CEN, ANSI...
Acute systemic toxicity (Animal LD50)
Cytotoxicity (Cell cultures LD50)
Mutagenicity (Salmonella typhoidea)
Implantation, local toxicity (Animals)
Pulpal & gingival reactions (Animals)
Sensitisation (Guinea pig)
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SSO Lausanne 15.06.2001
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SSO Lausanne 15.06.2001
Composite resin components
Monomers: BIS-GMA… TEGDMA... HEMA… UDMA.. BIS-PMA… UPGDMA… EGDMA… DEGMA… PRDMA... BIS-DMA…
Additives and contaminants: CQ… BPE…DPO...MBEP…HMBP…CEMA…BPA...
Degradation products: MMA… BEA… MAA… Formaldehyde...
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SSO Lausanne 15.06.2001
Chemical companies,information
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Relevance for daily clinical
practice?
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SSO Lausanne 15.06.2001
Estrogenic potential
Systemic toxicity
Secondary caries
Chronic allergy
Dentin and pulp reactions
Postoperative sensitivity
Pulp capping
Acute allergy
Clinical use of composite
resins and
biological concerns?
Local toxicity
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SSO Lausanne 15.06.2001
Acute allergy
Hensten-Pettersen, Eur J Oral Sci, 1998:
Anaphylactoid reactions in children have been reported following the placement of fissure sealants, which are based on the same ingredients as composite materials
Björkman & Helland, Nor Dent Assoc J, 2001:
Signals from the Sweden about asthma attacks in relation to restorative therapy using resin based materials cannot be verified by data from the Dental Biomaterials Adverse Reaction Unit in Norway.
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SSO Lausanne 15.06.2001
Chronic allergy
Kanerva et al., Contact Dermatitis, 1999:
Finnish dentists have the highest risk of any occupation for developing occupational allergic contact dermatitis. The risk is 6.4-fold as compared to the general working population.
Wallenhammar et al., Contact Dermatitis, 2000:
The prevalence of contact allergy to acrylates was below 1% in the population of responding dentists, and in most cases did not have serious medical, social or occupational consequences.
1-3%?
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Postoperative hypersensitivity
Christensen, J Am Dent Assoc, 1996:
The exact cause of tooth sensitivity related to class I and II resin restorations has not been clearly identified. There are many and varied clinical concepts associated with post-operative tooth sensitivity.
Cox et al., Pract Periodontics Aesthet Dent, 1999:
Cohesive hybridization of vital dentin prevents immediate postoperative hypersensitivity under all restorations and completely seals the entire tooth-restoration interface
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SSO Lausanne 15.06.2001
Dentin and Pulp reactions
Al-Fawaz et al., J Endod, 1993:
TEGDMA and HEMA are able to diffuse through dentin and cause pulp reaction without bacterial infection.
Schmalz, Eur J Oral Sci, 1998:
Composite resins apparently do not evoke pulp damage if bacterial penetration is prevented. Bacterial penetration may occur because of gap formation due to polymerization shrinkage.
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Pulp exposure -capping
Costa et al., J Endodont, 2000:
Adhesive resins may release particulates that may induce a persistent local inflammatory reaction. Consequently, in this specific condition, these materials cannot be regarded as biocompatible
Schuurs et al., Endodontic Dent Traumatol, 2000:
The cytotoxicity of the resin-based composites and the temperature rise during polymerisation may not be of concern…. Based on available data, pulp capping with resin-based composites may be said to be promising.
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Secondary caries -Plaque Adhesion
Leinfelder, In: Garber & Goldstein, 1994:
The occurrence of secondary caries is greater than it is with amalgam. In addition, secondary caries progresses at a much slower rate in conjunction with amalgam than it does with posterior composite resins.
Lutz & Krejci, Compend Contin Educ Dent 1999:
Amalgam alternatives, if they are placed using a sophisticated operative technique resulting in perfectly adapted restorations, meet the high expectations outlined in the Swiss Dental Society quality guidelines
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Local toxicity
Schmalz, Eur J Oral Sci, 1998:
The gingiva may be damaged due to chemical release or due to bacterial growth on composite resins
Söderholm & Mariotti: J Am Dent Assoc, 1999:
Toxicity of commonly used dental resins should not be of concern to the general public.
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SSO Lausanne 15.06.2001
Systemic toxicity
Engelmann et al., J Dent Res, 2001:
TEGDMA is not only cytotoxic, mutagenic and acts as a surfactant-like agent, but may have a toxic potential which can result in higher susceptibility of cells for subsequent damages or injuries from other xenobiotics.
Hume & Gerzia, Crit Rev Oral Biol Med, 1996:
There are no data which suggest that systemic toxicity is a risk with any of these materials.
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Estrogenic potential
Olea et al., Environ Health Perspect, 1996:
The use of BIS-GMA-based resins in dentistry, and particularly the use of sealants in children, appears to contribute to human exposure to xenoestrogens
American Dental Association. www.ada.org, 2001:
There is no evidence to suggest a link between any
adverse health condition and Bisphenol-A
leached out of dental sealants.
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The information overload in modern dentistry
Meetings/ courses
Colleagues
Advertising- producers- colleagues
“Vitenskap”
WWW
Patients & (-groups)
Popular magazines & Media
Dental‘science’700 journals: 25 000 articles/yr
Dental literature
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Why the confusion?
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Why confusion?
There is little reliableinformation with respect to the biological interactions between resin components and various biological tissues.
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Why confusion?Little reliable information on
biological interactions between resin components and biological tissues:
1. Variables in planned studies influence the outcomes.
Controlled, Uncontrolled, Confounding variables
Synergy of variables?
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In vitro studies; e.g. elution of leachable components- variables
Surface oxygen inhibition
Time after curing before immersion
Type of solvent; water, ethanolSelective extraction
Time in solvent
Unreacted components vs. DegradationOxidation Hydrolysis
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In vitro / In vivo studies; variables
Light intensity & Spectral distributionAccess of light & Depth of light cureCuring timeConversion rate Polymerization shrinkageMicroleakageWear (Enzymatic) Biodegradation
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SSO Lausanne 15.06.2001
Why confusion?
Little reliable information on biological interactions between resin components and biological tissues.
1. Variables in planned studies influence the outcomes.
2. All study designs are correlated with a probability of error.
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SSO Lausanne 15.06.2001
1 Systematic review of randomized clinical trials (RCT) & Individual RCTs
2 Systematic review of cohort studies & individual cohort studies & Low quality RCTs
3 Systematic review of case-control studies& Individual case-control studies
4 Case-series & Poor quality cohort and case-control studies
5 Laboratory research & Expert opinion without explicit critical appraisal & Rationale basis on physiology & Case descriptions
Appraisal of harm; study design and probability of error
http://cebm.jr2.ox.ac.uk/docs/levels.html
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Strategy for finding
answers?
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SSO Lausanne 15.06.2001
Learn critical appraisal: EBM
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Health
Techn.
Assess
Syste-
matic
review
Random
Control
Trial
Clinical
trial
Other
evidenc
e
Acute allergy - - - - +
Chronic allergy - - - + ++
Local toxicity - - - + ++
Postoperative - - + + ++
Dentin and pulp - - + ++ +++
Pulp exposure - - + ++ ++
Sec.caries/ plaque - - + + ++
Systemic toxicity - - - - +
Estrogenicity - - - + +
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Strategy in daily clinical
practice 1. Identify potential hazard
2. Read producer’s instructions 3. Keep adequate risk attitude
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SSO Lausanne 15.06.2001
The allergy-project in Sweden 1997-2001.
Aim: Establish safe routines for handling of resin materials in dentistry according to new work regulations
1994/95: 150 individuals in dental care had developed allergy toward resins1996: New regulations for handling resins introduced in dental sector1997: Brochure and poster produced and distributed to all dental clinics in Sweden
Inspections of all importers and producers Survey to 3000 employers of dental clinics, (Replies 2680= 91%)19634 individuals registered - 6372 dentists22% clinics reported health problems related to resins 6% of all individuals reported health related problems (n=1234/19634)Only 99 of these had been reported to national register for adverse reactions8% of all dentists reported health related problems (n=511/6372 dentists)3% had allergy documented by physician (n=217 / 6372 dentists)Multiple inspections by work authoritiesMany breaches of regulations (n= 1234)Several follow-up inspections
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SSO Lausanne 15.06.2001
Identify hazards
Read Safety Data SheetsUncured material: Direct contact can cause
eye and skin irritation.
The material is contraindicated if a person
is known to be allergic to any of the
ingredients of the product.
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Learn First Aid measures
Eye contact
Flush with plenty of water. Consult a physician if irritation persists.
Skin contact
Wash thoroughly with soap and water.
Ingestion
No hazards anticipated from swallowing small amounts incidentally to normal handling.
Inhalation
Remove to fresh air.
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SSO Lausanne 15.06.2001
Employ adequate handling and
storage & personal protection
Handling
Personnel that handle composite resins must be
adequately trained
Personal protective equipment
Respiratory protection
Hand protection Gloves - replace if
contaminated
Eye protection Safety goggles
Check light source regularly for power output
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Thank you for your
kind attention
http://www.odont.uio.no/prosthodont/sso