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  1. 1. MORE: Research PlanPatient’s opinions on the health effects of mercury in dental amalgam.<br />By Marise Butler<br />
  2. 2. Background<br />As an oral health student I want patients’ to be aware of the properties of the restorative materials used.<br />Attention has been placed on the health effects of amalgam.<br />Amalgam is still widely used and accepted in New Zealand and around the world.<br />Conducting a study on amalgam would reveal patients opinions, to see if they felt the mercury in amalgam had impacted their general health in any way.<br />
  3. 3. Research Plan<br />Aims: <br />To explore dental patients views on mercury in amalgam. <br />To see if there is a link between mercury in dental amalgam and the health effects. <br />
  4. 4. Literature Review<br />Dental amalgam, also known as silver fillings, consists of 50% mercury as well as many other metals (Ferracane, 2009). <br />Due to the high mercury content, amalgam has become a controversial restorative material as some individuals with amalgam restorations claim it has affected their general health due to the release of the mercury (Medsafe, 2010). <br />Dental companies have been producing alternatives such as composite or Glass Ionomer Cement (GIC) for cosmetic reasons as they are tooth coloured. Patients may also choose these alternatives as they do not contain mercury (Larkin, 2002).<br />The properties of amalgam are that it is cost effective, strong, durable, easy to use and can withstand heavy chewing. These properties contribute to why amalgam has been the restorative material of choice by dental professionals for over 150 years.<br />
  5. 5. Literature Review<br />Millions of patients have been treated with no adverse health effects reported, although there were a few rare cases of patients who have a mercury allergy (Colgate, 2010).<br /> In 1990, approximately 200 million amalgam restorations were placed, proving the material is widely used and safe (Green, 2004). <br />Due to the vast number of amalgam restorations being placed over long periods of time, with almost no adverse health effects reported, authorities such as the British Dental Association, United State Public Health Service, Federation DentaireInternationale (FDI) World Dental Federation and World Health Organisations (WHO) all agree and state that amalgam is safe to use (Colgate, 2010; MOH, 2008). <br />The New Zealand Ministry of Health (MOH) and Medsafe support the use of amalgam for dental restorations and have based their guidelines on the information currently provided by the American Food and Drug Administration (FDA) (Medsafe 1999; MOH, 2008). <br />This shows amalgam is a trusted restorative material, except for patients with a mercury allergy. <br />
  6. 6. Literature Review<br />One study found an individual with amalgam restorations absorbs minuscule amounts of mercury vapour, far below the level that exerts any adverse health effect. This study was performed on ten patients, who claimed their health symptoms were related to the mercury content of amalgam. Results showed the ten participants did not have significant mercury levels as they had neither a higher estimated daily uptake of inhaled mercury vapour, and did not have a higher mercury concentration in their blood or urine in comparison to eight patients who had no reported health complaints (Quackwatch, 2006). This research supports the use of amalgam, as health is almost unaffected by the minuscule amount of mercury vapour. <br />Another study (Bailer et al, 2001) also points out that there is no significant link between mercury levels in the blood and the amount of amalgam restorations in patients with reported symptoms. <br />Some studies relate problems patients attribute to amalgam restorations being psycohosomatic in nature and patients have worsened their beliefs by receiving incorrect information from the media (Quackwatch, 2006). <br />
  7. 7. Literature Review<br />In contrast, a study (Abraham, Svare, & Frank, 1984) brings attention to an increase in blood mercury levels. This suggests mercury levels should be a concern to the patient which encourages the move from amalgam to alternative restorative materials such as composite/GIC. <br />Another study (Damian, Michael, Derek, & Boyd, 2006) found that patients that removed their amalgam restorations experienced reduced symptoms such as memory loss, depression and fatigue, which they claimed were associated with the mercury content. <br />The FDA is using scientific literature to investigate claims that amalgam adversely affects the health of pregnant women and of younger children (MOH, 2008). <br />While New Zealand supports the use of amalgam, countries like Austria, Canada, Germany and Sweden have restrictions on the use of amalgam due to wider environmental effects of mercury and low mercury uptake (Medsafe, 1999).<br />
  8. 8. Literature Review<br />One of the major drawbacks with patients who want to change from amalgam to composite is that every time restorations are re-done the size of the cavity is increased and more sound tooth structure, which is free from decay, is destroyed (Larkin, 2002). Therefore, the MOH does not recommend amalgam removal or replacement, without clinical indication as it can’t be justified on present clinic and scientific evidence. The exception is the patient who has an allergy or hypersensitivity reaction to amalgam (Medsafe, 1999).<br /> Research reveals that mercury levels have been shown to be minuscule. Therefore, if there has been almost no adverse health effects related to the mercury in amalgam (aside from mercury allergy) and it is classed as safe to use, then why are patients choosing to use alternative restorative materials such as composite/GIC? <br />Therefore it is worth enquiring the patients’ opinions on the health effects of mercury in amalgam to address this gap. <br />
  9. 9. Reserach Question<br />What are the patients’ opinions on the health effects of mercury in amalgam?<br />
  10. 10. Methodology<br />As this study is seeking the patients’ opinions regarding the health effects of mercury in amalgam, the methodology is qualitative. <br />This is because focus groups will be used as they are the most effective way for gaining opinions as it allows for discussion about mercury with all group members. <br />Choosing focus groups over individual interviews allows everyone’s opinions to be heard and shares knowledge on the topic. <br />If this research was done using a quantitative approach, opinions would be limited as surveys do not allow the participant to explain their thoughts clearly due to short answer questions (Davidson, 2005).<br />
  11. 11. Design of the study (Sample selection).<br />This research study does not use random selection methods (which is a quantitative method), as it needs specific participants. <br />This enables specific data collection called purposive sampling which is a form of non-probability sampling. It samples individuals that are selected due to a characteristic, in this case the need for restorative restorations with the option of using amalgam or composite/GIC. <br />This allows the researchers to obtain the opinions of the participants which is a sampling approach consistent with qualitative research. <br />In order to gain specific participants through the purposive sampling method, dental professionals (dentists and health care centres) who have prospective patients with restorative work required will be provided with information regarding the study. <br />This information will state that the targeted participants must be familiar with amalgam and visit their dental professional regularly (Syque, 2010).<br />
  12. 12. Design of the study (Sample selection).<br />Focus groups will be used to seek patient’s opinions regarding amalgam and composite/GIC, which is a qualitative approach. <br />Focus groups limit the number of participants in each group, so that each member feels they have a chance to self-report which is an effective method which allows the participants to say their opinions on the discussion and be acknowledged (Polit, 2008). <br />To keep the focus groups on track, each group will have a researcher to help facilitate the discussion on the health effects of mercury in amalgam. <br />Data saturation will occur when the focus groups have discussed all the participants’ views and opinions about the mercury in amalgam and no new information is being discussed. <br />Qualitative research data is analyzed throughout the study while it is taking place. Another qualitative method is individual interviews, however this would limit the discussion of the topic resulting in less depth of the topic. <br />A quantitative approach would be surveys which are not ideal for this type of research as it would result in generalised answers with no in-depth discussion (Davidson, 2005). <br />
  13. 13. Cultural Issues<br />New Zealand studies must comply with the three principles of the Treaty of Waitangi which are: partnership, participation and protection (Moon, 2008). <br />All ethnicities are eligible to participate in the study. <br /> <br />Partnership is represented by the researcher and the participants working together to achieve a positive educational outcome regarding health. It is about mutual respect, making sure all participants are treated equally, spoken to with respect and understood for any cultural beliefs they have. For example, an important cultural belief is that the head is tapu (sacred) which may be a reason Maori are not having amalgam fillings. Informed consent is of the highest importance to maintaining partnership (Moon, 2008).<br />Participation is about acknowledging the barriers participants may face. Maori may have limited English which would prevent them from understanding and discussing the amalgam topic therefore an interpreter will be arranged for these participants. Another barrier is transportation, as some participants may not be able to attend due to being of low socio-economic status therefore car-pooling can be arranged for these participants (Moon, 2008). <br /> <br />Protection is about making sure the participant’s time is not wasted. Therefore the focus groups will be arranged with the participants at a convenient time and will be allocated a period of time such as one hour. The participants confidentially will be maintained throughout the study (Moon, 2008).<br />
  14. 14. Instrument (Measurement)<br />Qualitative studies use instruments, in this case the researcher. <br />The researcher’s role is to draw out information about the topic through discussion, classifying the responses. This results in directed conversations focusing on the mercury in amalgam and exploring the controversies surrounding the topic (Babbie, 2008; Dingwall, 2008). <br />This will be achieved through open-ended questions allowing the participants to be able to respond with reasoning. For example: ‘What are your personal views on the mercury content of amalgam?’ <br />This allows the participants to give their view and elaborate as to why they feel that way, which will allow discussion between the participants of the focus groups to emerge. <br />The researcher will record the discussions from the focus group sessions, but due to confidentiality, the researcher will not mention or identify any individual involved in the discussion. <br />Rigour is essential in a research study as it provides accuracy. Reflexivity is used to maintain accuracy, as it requires the researcher to be aware of contributions they may make or that they themselves might influence in the focus group sessions which could affect the accuracy of the study results (Davidson, 2005).<br />
  15. 15. Data Collection Methods<br />The focus groups are a method of purposive sampling within non-probability sampling in qualitative studies (Babbie, 2008; Polit, 2008). <br />The information shared in these focus groups will be pivotal in answering the research question. The groups will be encouraged and guided by the researcher to talk to each other about their experiences and knowledge of amalgam. <br />As the researcher needs to have a background on amalgam to keep up with the conversation, he/she will not contribute to the thoughts and ideas of the participants. <br />This ensures quality in the research as it is not about the researcher’s thoughts or opinions. <br />In keeping with the three principles of the Treaty of Waitangi, the researcher will guide the conversation utilising the time the group has allocated, until the participants feel they have answered the questions asked. <br />As interpreters will be used, if required, there will be no discrimination and this will allow participants to feel involved and appreciated. <br />The location of the focus groups will be held at Auckland University of Technology (AUT) as it is a neutral environment. Food and beverages will be provided to encourage participants to attend and keep them focused, allowing them to feel able to socialise with each other (Moon, 2008).<br />
  16. 16. Data Analysis<br />The results of the individual opinions and group decisions will be documented well, noting the patterns and/or meaning of the data obtained from the focus groups. <br />The responses will be coded which will allow these themes to emerge. <br />Thematic analysis is a qualitative data analysis method. Once the data has been analysed, the researcher will go over the analysis to gain confirmation and validation of the results which will improve rigour (Babbie, 2008). <br />
  17. 17. Ethical Issues<br />The ethics committee that needs to approve research study is Auckland University of Technology Ethics Committee (AUTEC). This ensures study respects the three principles of the Treaty of Waitangi, as it protects the participants’ rights and ensures nothing has been left out of the research proposal at the negligence of the organisation or researcher involved (Auckland University of Technology, 2010; Australian Evaluation Society, 2000; Moon, 2008). <br />Participating in the research study is voluntary. They are allowed to withdraw their consent and opt out of the research at any time. Informed consent must declare any risk of harm, such as emotional, psychological or physical that the participants may be subjected to. It also will declare what the intention of the research study is, its benefits and factors such as time and cost the participant may experience. Informed consent will also disclose the contact details of the research organisation.<br /> <br />Confidentiality and anonymity must be maintained throughout the research study. This means information gained from the participants for the purposes of the research study is not disclosed, assuring their privacy is maintained at all times (Auckland University of Technology, 2010).<br />
  18. 18. Expected Outcomes<br />From conducting this research dental patients’ opinions on the health effects of mercury in amalgam will be explored. These views will help to identify if there is any link between mercury in dental amalgam and the health effects. The gap as to why patients are moving away from a safe restorative material will be therefore identified.<br />
  19. 19. References 1/6<br />Abraham, J. E., Svare, C. W., & Frank, C. W. (1984). The effect of dental amalgam restorations on blood mercury levels. Journal of Dental Research, 63(1), 71-73. doi:10.1177/00220345840630011801<br />Auckland University of Technology (2010). Ethics knowledge base. Retrieved on September 30, 2010 from<br />Australian Evaluation Society (2000). Code of Ethics. Retrieved on September 30, 2010 from<br />
  20. 20. References 2/6<br />Babbie, E. (2008). The basics of social research. Thomson/Wadsworth, Belmont, CA.<br />Bailer, J., Rist, F., Rudolf, H., Staehle, H. J., Eickholz, P., Triebig, G., . . . Pfeifer, U. (2001). Adverse health effects related to mercury exposure from dental amalgam fillings: toxicological or psychological causes?. Psychological Medicine, 31(2), 255-263. doi:10.1017/S0033291701003233<br />Colgate, (2010). Fillings. Retrieved on August 22, 2010, from,280,<br />
  21. 21. References 3/6<br />Damian, P. W., Michael, E. G., Derek, C., & Boyd, E. H. (2006). Mercury toxicity presenting as chronic fatigue, memory impairment and depression: Diagnosis, treatment, susceptibility, and outcomes in a New Zealand general practice setting (1994–2006).Neuroendocrinology Letters, 27(4), 415-423. Retrieved from<br />Davidson, E. J. (2005). Evaluation Methodogy Basics: The nuts and bolts of sound evaluation: Sage Publications.<br />Dingwall, R. (2008). Qualitative health research. Sage Publications.<br />
  22. 22. References 4/6<br />Ferracane, J. L. (2001). Materials in dentistry, principles & applications, (2nd ed.). Lippincott, Williams & Wilkins: Philadelphia, USA.<br />Green, S. A. (2004). Dental amalgam overview. Retrieved on August 22, 2010, from<br /> <br />Larkin, M. (2002). Don't remove amalgam fillings, urges American Dental Association. The Lancet, 360(9930), 393. doi: 10.1016/S0140-6736(02)09626-5<br />
  23. 23. References 5/6<br />Medsafe. (1999). Archived medical devices. Retrieved on August 22, 2010, from<br />Moon, P. (2008). Health in the context of Aotearoa. The Treaty of Waitangi. Oxford University Press: New York.<br />New Zealand Ministry of Health (2008). Ministry of Health statement on amalgam and other dental filling materials. Retrieved on August 22, 2010, from<br /> <br /> <br />
  24. 24. References 6/6<br />Polit, D. F. (2008). Designing and implementing a data collection plan. Lippincott, Williams & Wilkins: Philadelphia.<br />Quackwatch, (2006). The “Mercury Toxicity” scam: How anti-amalgamists swindle people. Retrieved on August 22, 2010, from<br />Syque. (2010). Non-Probability Sampling. Retrieved August 22, 2010, from<br /><br />