Rev Saúde Pública 2007;41(2)

João Geraldo Bugarin JúniorI

Bioethics and biosafety: the
Volnei GarrafaII
use of biomaterials in dental
practice

ABSTRACT

OBJECTIVE: To analyze the use of biomaterials in surgical procedures carried

out by specialist dental surgeons, in light of the Principalist Bioethics Theory
and the Individual and Collective Ethics of Responsibility.
METHODS: Dental surgeons (n=95), who were registered as specialists at the
Regional Dentistry Council of Brasilia as of 2002, completed questionnaires
regarding the use of biomaterials in their work. Data relating to sanitary
control were collated, based on these dental surgeons’ responses and research
at relevant organizations.
RESULTS: All of the professionals in the survey used biomaterials on a regular
basis; 45% believed their use to be risk-free for patients, and 48% did not
classify biomaterials as drugs. About 70% of professionals trust the source of the
biomaterials even though membranes and bones are the items most commonly
bought from individual suppliers. Nonetheless, 96% of interviewees believed
that government sanitation agencies should regulate more. More than half of
the professionals (51%) pointed to little or no participation by the patient in
the process of therapeutic choice. A copy of the informed consent form was
provided by 12% of the dental surgeons interviewed produced.
CONCLUSIONS: The results showed that the professionals use biomaterials
without knowing about related risks and adverse side effects, contrary to the
principle of beneficence. Government agencies and professional bodies alike do
not show evidence of observing public responsibility ethics. Informed consent
is not yet integrated fully into professional practice and the doctor-patient
relationship in dentistry remains markedly vertical.

KEYWORDS: Bioethics. Biosafety. Biomaterials. Dentistry.

INTRODUCTION

Significant advances in the use of biomaterials in clinical dentistry over the last
I
Programa de Pós-graduação em Ciências da decade mean that these materials are now used as powerful therapeutic tools in
Saúde. Universidade de Brasília. Brasília, surgical procedures, particularly in the correction of bone defects.3 However,
DF, Brasil in spite of these proven benefits, the use of biomaterials requires the dental
II
professional to take great care, both clinically and ethically, in analyzing the
Cátedra Unesco de Bioética. Universidade
de Brasília. Brasília, DF, Brasil risks and benefits that may come with the use of biomaterials.

Correspondence: Anthropological and archeological studies show that primitive communities

Cátedra UNESCO de Bioética were concerned with dental prosthetics. A human jaw bone of Mayan origin
Universidade de Brasília – UnB
Caixa Postal 04451
dating from the 7th Century AD was found to contain three small fragments of
70904-970 Brasília, DF, Brasil coral that served as substitutes for the mandibular incisors. Using radiography
E-mail: [email protected] exams, researchers found that compact bone had formed around these fragments.
As a result, these were considered the world’s oldest example of alloplastic
Received: 24/10/2005
Reviewed: 5/9/2006 implants successfully inserted into a living human being. This example shows
Approved: 27/11/2006 that, for a very long time, materials have been inserted next to oral tissues
2 Bioethics and use of biomaterials in dentistry Bugarin Júnior JG & Garrafa V

as a replacement for lost teeth, without knowing the The Principlist theory of bioethics, proffered by Beau-
biological consequence. This empirical practice con- champ & Childress1 (2001) in “Principles of Biomedi-
tinued throughout the Middle and Modern Ages, when cal Ethics”, has become the prime theoretical basis for
dentistry was considered to be essentially the work of the new field of biomedical ethics. It applies a system
craftsmen, without any scientific basis. of principles – autonomy, beneficence, non-maleficence
and justice – to the area of medical care in everyday
However, developments in biotechnology that began
situations involving professional-patient relations.
in the 1950s and have gathered speed in recent years
have given rise to significant advances in dentistry The speed of medical and technological advances means
and increased the scope of work of dental surgeons that the work of health care professionals involved in
and reinforced the discipline as a science. At the same the area of new biomedical discoveries requires more
time, the responsibility of the dental professional has careful ethical consideration.6 It is in this context that
increased and he or she is now required to keep up to bioethics appears as a new field of study and reflection
date with new areas of research.4 in morals and ethics, involving different developments
In today’s globalized world, scientific discoveries are and subjects. Its focus is on the conduct of the health
introduced and swiftly absorbed into clinical practice. professional, in relation to citizenship and human
In dentistry, new products are launched daily, most of rights, in contexts of time and space where people find
which are used in dental surgery. When these products themselves vulnerable, both in terms of their access to
are used, they come into direct contact with living and search for health care.
tissues, such as dentin, pulp, the alveolar bone and
Muñoz & Fortes** (1998) argue that the patient has
periodontal tissue, and sometimes stay in contact for
the moral right to be given explanations about the na-
prolonged periods.
ture and objectives of procedures, be they diagnostic,
Biomaterial is defined, in the broader sense, as any preventive or therapeutic. In the same way, the patient
pharmacologically inert material that is capable of should be informed about the invasiveness, length of
interacting with a living organism without causing treatment, benefits, likely discomfort and potential
adverse reactions either at the site of the implant or physical, psychic, economic and social risks that could
across the whole organism.9 The treatment with dental be involved. The health care professional should offer
biomaterials of gum, mucosal and hard tissues, repre- possible alternatives to treatment, where available.
sents a therapeutic risk that can only be contained if The person needs to be informed about the presumed
the dental professional has knowledge of the qualities, effectiveness of the proposed course of action, and the
strengths and properties of the products. probability of any changes in levels of pain, suffering
and pathological conditions. In other words, he or she
The use of biomaterials without any recognized criteria should be clearly supplied with the information required
for biosafety not only causes clinical problems such as to make informed decisions.
therapeutic failure, but also gives rise to ethically con-
flicting situations. This is because the patient may un- Graham & Harel-Raviv6 (1997) explain that informed
dergo treatment without knowing about the subsequent consent is a fundamental instrument in the process of
risks, either to himself or to the dental professional.4 communication between the patient and health profes-
sional. With this in mind, the present article sets out to
Schramm* (1998) defines biosafety as “the series of
analyze the use of biomaterials in dentistry with respect
actions aimed at preventing, minimizing or eliminating
to criteria such as use, risks, origins, commercializa-
the risks involved in activities such as research, produc-
tion, sanitary control and participation of the patient in
tion, teaching, technological development and service
therapeutic choice.
provision, risks that could jeopardize good health, the
environment or the quality of work under development”.
Both bioethics and biosafety are concerned with the METHODS
probability of risks, with negative impacts on the qual-
ity of life of individuals and populations and with the The use of biomaterials by dental surgeons was ana-
adoption of new practices. However biosafety quanti- lyzed, in relation to biosafety measures and in light
fies and measures risks and benefits, while bioethics of the Principlist Theory of Bioethics (Beauchamp &
analyses the rational arguments which justify or fail to Childress1 2001) and the Ethics of Individual and Col-
justify such risks. lective Responsibility (Jonas7 1990; Garrafa5 1995).

* Schramm FR. Bioética e biossegurança. In: Costa SIF, Garrafa V, Oselka G. (orgs.). Iniciação à Bioética, Conselho Federal de Medicina,
Brasília, 1998, p.217-230.
** Muñoz DR, Fortes PAC. O princípio da autonomia e o consentimento livre e esclarecido. In: Costa SIF, Garrafa V, Oselka G. (orgs.).
Iniciação à Bioética. Brasília, Conselho Federal de Medicina, Brasília, 1998, p. 99-110.
Rev Saúde Pública 2007;41(2) 3

The specializations in which biomaterials are most used Measures for regulation, standardization or surveillance
in professional practice were chosen. It was decided of the use of biomaterials on the part of governmental
that the study would include all specialists who work authorities or professional-level councils, were evaluated
in these areas and who have registered as specialists at by searching for information in the publications of these
the Regional Dentistry Council of the Federal District organizations and on the web-sites of each institution.
(CRO-DF in the Portuguese) as of 2002.
The elements relating to safety and regulation of these
Once the study group had been determined, criteria materials were evaluated by means of an analysis of the
for inclusion were established, as follows: participants responses given by interviewees in the questionnaire.
should be specialists in periodontology, dental implants
The project was submitted to the Committee on Re-
and buco-maxillofacial surgery and traumatology, and
search Ethics at the Faculdade de Ciências da Saúde of
agree to partake independently in the research by sign-
the Universidade de Brasilia, so as to assess the ethics
ing the terms of informed consent. and the technical and scientific content of the research,
Of the original 123 dental surgeons working in the with approval subsequently being granted. Participants
aforementioned specializations and included in the in the study signed informed consent forms.
official list provided by CRO-DF, 28 professionals
were excluded from the study for one or more of the RESULTS
following reasons: their place of residence was not
Brasilia, their current address was not available through There was a predominance of male specialists (75%),
the CRO-DF, or they did not agree to participate in the with the majority aged between 29 and 39, and hold-
research. Therefore the total number of participants ing between 11 and 20 years of experience (52%). The
was 95 professionals, which equates to 77.2% of the largest group was of periodontists (45%), with between
total study sample. 6 and 10 years of experience as specialists (36%).

To gather data, an interview questionnaire was drawn The majority (51%) of dental surgeons reported using
up, containing 13 questions, of which nine were closed the terms of consent with the patient in their consul-
tations. Of these, only 12% produced copies of this
and four open.
document, when asked.
The aim of the first set of questions was to gather infor-
mation on the profile of the professional involved in the
research, with regard to sex, age, length of education, Table 1. Numbers and Proportions of specialists who consider
specialization and period of time operating as a regis- biomaterials to be a medicine. Federal District, Brazil, 2002.
tered specialist. Other questions included: information Response N %
about the patient’s participation in therapeutic planning, Yes 41 43
by means of use of the terms of consent; notions of risk No 45 47
and biological effects in the use of these materials on
Do not know 7 8
patients; and details about the biomaterials most used
in their professional practice. Blank 2 2
Total 95 100
The questionnaire was designed to gather data on the
degree of concern displayed by the professional in
relation to the origin, quality, regulation and source
Table 2. List of materials most frequently cited by specialists.
of the biomaterials. To close, the final question sought Federal District, Brazil, 2002.
to examine once gain the notion of risk in the use of
Material N
biomaterials, by means of an open question, so that the
professional could freely express his or her opinion. Reabsorbable membrane 42
Implants 38
In the first instance, the questionnaire was applied to Lyophilized bone 36
a pilot sample of ten professionals, chosen at random
Non-reabsorbable membrane 30
from the entire sample, in order to analyze the appli-
cability, clarity and appropriateness of the proposed Bovine bone 29
objectives. Since no changes to the questionnaire were Hydroxyapatite 27
subsequently necessary, the pilot sample was used in Human bone 26
the final study. A group of ten dental students received Membranes 24
training and guidance on the use of the questionnaires
Autogenous bone 20
for the rest of the group under study, with supervision
Capset (calcium sulfate) 18
provided by the researcher at all times.
4 Bioethics and use of biomaterials in dentistry Bugarin Júnior JG & Garrafa V

Table 3. Total number of materials most frequently purcha- The results show that the professional practice of
sed from independent suppliers by dental surgeons. Federal these specialists is essentially paternalistic: more than
District, Brazil, 2002.
half (51%) pointed to little or no participation on the
Material N part of the patient in the process of therapeutic choice
Reabsorbable membrane 8 (Table 4).
Lyophilized bone 6
In relation to the notion of risk to the patient in the use
Membranes 5
of these biomaterials, 55% of dental surgeons believed
Bovine bone 4 there to be some form of risk to the patient. The most
Non-reabsorbable membrane 3 frequently mentioned were: infection, contamination,
Human bone 3 transmission of disease, rejection, incorrect manipula-
Autogenous bone 3 tion, allergic reactions, inefficiency and manufacturing
defects.
Capset (calcium sulfate) 3
Alloderm 3
DISCUSSION

Analysis of the results allowed for further reflection

Table 4. Total numbers and proportion of specialists, accor- about the use of biomaterials by specialists.
ding to level of patient participation in the choice of materials.
Federal District, Brazil, 2002. The origins of the materials are diverse, primarily
Patient participates in choice N % due to the fact that a large variety of membranes and
Always 22 23
lyophilized bone of bovine origin are available on the
Brazilian market. Among the animal biomaterials are
Usually 21 22
bone morphogenetic protein and lyophilized bone;
Occasionally 27 29 among the synthetic biomaterials are hydroxyapatite
Never 21 22 and calcium sulfate. The use of biomaterials that are of
Blank 4 4 animal and synthetic origin can largely be attributed to
Total 95 100
the fact that the Brazilian Constitution* forbids the sale
and use of materials of human origin. Furthermore, Law
9434 of 4 February, 1997, which relates to the donation
of organs and accompanying procedures, establishes
Nearly 47% of those interviewed did not consider penalties and fines for any kind of sale of human organs
biomaterials to be a form of medication. or tissues in Brazil.

The 10 most commonly used materials are presented, For Berlinguer & Garrafa2 (2001), in future there will
in descending order, in Table 2. The most frequently be a shift away from the use of human biomaterials
cited were membranes, implants and lyophilized bone towards xenograft, as a result of shortages in the global
graft material. supply of human bones. However, there remain many
doubts about the relationship between cells from dif-
The materials most frequently purchased by dental ferent species. Much polemic surrounded the proposal
practices and bought directly from independent suppli- to use the organs of animals that had been genetically
ers were membranes and bones; those purchased from treated, due to long-term effects, principally in the field
import companies were implants and bones (Table 3). of immunology. 2
Implants are the material most commonly purchased
The biomaterials most commonly referenced by import
directly from the factory, particularly from domestic
companies are implants manufactured in other coun-
suppliers; of materials purchased abroad, titanium
tries and lyophilized human bone. The lack of a bank
screws and plates were most commonly mentioned. of human bones for commercial purposes in Brazil,
Seventy percent of professionals said that they trusted similar to those that already exist in the United States,
the source of these materials. Singapore, Hong Kong and elsewhere, has meant that
there has been a growth in the number of companies
When asked about regulation of biomaterials, almost all
importing lyophilized human bone.
professionals (96%) replied that there should be more
controls. The Brazilian Ministry of Health was most Among the materials that dental surgeons most fre-
commonly proposed (by 50% of interviewees) as the quently purchase from independent suppliers, are
agency best suited to perform this function. also reabsorbable membranes and lyophilized bone

* Federal Constitution of Brazil, Title VIII – on Social Order – Ch.II – section II – on health – article 100 – clause 4.
Rev Saúde Pública 2007;41(2) 5

(Table 4). This finding gives cause for concern since of the mechanical process of chewing, which may result
all possible sources, independent suppliers are indeed in biological interactions.
the least likely to control the quality of the origin of
such materials.4 Many of the biomaterials and equip- This lack of knowledge on the part of dental surgeons
ment that have North-American patents are produced in calls for a review of professional conduct. By using
developing countries, such as Taiwan, Korea, Indonesia materials without appropriate knowledge or by not
and others, where a large proportion of the labor force following the biosafety principles inherent in their
is cheap and unqualified. Outside of the USA, without use, the dental surgeon goes against the principle of
regulation of the hygiene of their sources, these materi- beneficence. Furthermore, he or she possibly fails to
als are not covered by the strict controls established by abide by the principle of non-maleficence (primum non
the Food and Drugs Administration (FDA).4 The risks nocere – above all, do no harm).
inherent in the use of biomaterials are minimized by
For Jonas7 (1990), it is necessary for ethical reasoning to
means of biological processing during their prepara-
advance at the same pace as scientific and technological
tion.9 If the professional uses biomaterials of doubtful progress. The freedom to generate and use new knowl-
origin or those that are sourced locally without hygiene edge must show a direct relationship with responsibility
controls, the biological risks to the patient increase – both individual and public – in the process of scientific
and the procedure risks falling short of the principle discovery and its consequences.
of beneficence. Above all, protection of the patient is
the primary objective both of bioethics, through the By pointing to a compromise in the ethics of public
principles of beneficence and non-maleficence, and responsibility, the lack of appropriate controls has
of biosecurity with a view to prevent and avoid risks. been highlighted. This is because the review of the
Nonetheless, quality control of materials becomes abovementioned biomaterials for the purposes of
fundamental. registration is purely a formality, and does not involve
biological tests. In addition, this ethical compromise
From the perspective of the Principlist Theory of Bio- was not referred to by professional bodies such as the
ethics, one notes that the principle of patient autonomy dentistry councils, whose legal role it is to promote,
is frequently ignored. Most interviewees stated that using all available means, the highest technical and
the patient rarely or never participated in the decision moral standards in dentistry. Dental professionals are
about treatment. The use of terms of informed con- not provided with any guidance or norms for the use
sent has not yet been incorporated into professional of biomaterials in Brazil.
practice. The lack of patient participation was also
noted in recent research that assessed the records of The results show that 96% of dental surgeons recognize
dental implant specialists in São Paulo and found that the need for regulation in the use of these materials.
50% of interviewees did not consider it important to This leads to the conclusion that professionals do not
pass on information about treatment to their patients.8 feel secure about the control and regulation of these
These findings show that the patient’s autonomy is not products in Brazil, or that they are unaware of the
respected, and that the use of informed consent forms actions of the Brazilian Ministry of Health, through
has not yet been incorporated into professional practice, the Agência Nacional de Vigilância Sanitária (Anvisa
suggesting that the professional-patient relationship in – National Agency for Health Surveillance). Although
dentistry is still excessively vertical. some materials are registered at Anvisa, no measures or
guidelines for their use were found within the federal
Findings showed that dental professionals are not aware and regional dental councils.
of the risks and benefits of biomaterials, nor of their
biological origins, with 45% believing that there was For this reason, the monitoring of their sale, use and
no risk at all for the patient, and 56% do not consider scope by professionals, authorities and of all society
biomaterials to be a medicine. However, even if the is fundamental, as is, most importantly, the creation
biomaterials are thought to be inert, they will come of a robust policy for health surveillance of these
into contact with the oral cavity and be subjected to products.

REFERENCES

1. Beauchamp TL, Childress JF. Principles of biomedical 3. Garbin CM, Garbin NM. Enxertos ósseos e regeneração
ethics. 5ª ed. New York: Oxford University Press; 2001. tecidual guiada: noções básicas. São Paulo: Pancast;
1994.
2. Berlinguer G, Garrafa V. O mercado humano: estudo
4. Garrafa V. Bioética e odontologia. In: Kriger L,
bioético da compra e venda de partes do corpo. 2ª ed. organizador. Promoção de saúde bucal. São Paulo: Artes
Brasília (DF): UnB; 2001. Médicas; 2003. p. 495-504.
6 Bioethics and use of biomaterials in dentistry Bugarin Júnior JG & Garrafa V

5. Garrafa V. Novos paradigmas da saúde - a ética da 7. Jonas H. Il princípio responsabilitá. Torino: Einaudi;
responsabilidade: individual e pública. Saúde Debate. 1990.
1995;48:47-50.
8. Modafforre PM, Crosato E. Avaliação da documentação
6. Graham EP, Harel-Raviv M. The future of informed dos implantodontistas do Estado de São Paulo. RBP Rev
consent and patient-dentist communication. J Can Dent Bras Implantodont Prótese Implant. 2004;11:233-40.
Assoc. 1997;63:460-3.