¶ … direct examination of subjects for signs of periodontal disease and measurements of bacterial growth on the teeth, gum lines, and in the mouth in general, while also accounting for cardiovascular disease in order to measure correlations, in keeping with the methods best adapted to a direct examination of the research question at hand (Johansson et al. 2008; Tanzer et al. 2001). This type of direct experimental study will not require any longitudinal aspects to obtain relevant and meaningful data. The study participants will consist of two groups, one consisting of individuals with a prior diagnosis of cardiovascular disease and another control group of individuals that are of similar age but that have no diagnosed cardiovascular disease, and there will be approximately one-hundred-and-fifty individuals in each group, again in keeping with previous studies investigating similar questions (Johansson et al. 2008).
The proposed research will be fully and accurately defined and presented to the review board before any practical steps towards the contacting of institutions and participants for inclusion in the study commences. Privacy concerns and other ethical issues related to the identification of study participants will be dealt with through initial anonymous-making procedures, such that no one with direct research involvement will ever know the name or other non-medical identifying information about the subjects. Consent forms will clearly spell out the various steps that will be taken in the study and the information being sought.
Participants
All effort will be made to achieve the widest range of diversity possible in both population groups in the study in terms of race/ethnicity, gender, and other demographic features, and to ensure that the two populations groups are of similar makeup in these regards. No participants under the age of thirty will be included in the study, and given the criteria of a prior diagnosis of cardiovascular disease it is expected that the population will have an average age of approximately fifty to fifty five years of age, in keeping with other studies that investigated similar questions and utilized similar criteria (Ide et al. 2008; Tanzer et al. 2001). Height will not be a consideration for inclusionary or exclusionary criteria in the study, but obesity (a body-mass index of thirty or more) or extreme underweight (body mass index under fifteen) will be grounds for inclusion due to adverse impacts on the cardiovascular system resulting from the strains such conditions place on the body.
As the purpose of this study will be to achieve a meaningful and generalizable assessment of the country's risk factor as a whole, no specific target population will be sought, but rather a truly representative sample will be the goal of participant enrollment and the overall research study. To this end, participants will be recruited at several different public and private hospitals in different regions of the country, to increase the diversity of study enrollment. Specific demographic quotas based on regional data will be sought at each institution, though if suitable participants cannot be found quotas might go unmet in some areas and exceeded in others.
Instruments
Instrumentation needed for the research study will be relatively minimal and straightforward; necessary equipment for a standard checkup to determine cardiovascular health and other basic signs of chronic disease as well as scrapers, swabs, and vials for the collection of bacterial samples will be needed. It is possible that culturing of the bacterial samples will be desired, in which case additional instruments and controlled environment equipment will also be needed for the full completion of the study. In order to assess the exclusionary criteria related to weight, a standard scale and height ruler will need to be utilized along with caliper measurements to determine body mass index. Other than this and the instruments necessary for recording and analyzing the data collected using these instruments, it is not expected that any other resources will be necessary for this research study.
Procedure
Following initial measurements to determine suitability for inclusion in the study, the procedure for this research will take place as follows: participants will be divided into groups based on their cardiovascular health. Standard physical examinations of each participant will be made, and this basic data recorded. More extensive examinations of cardiovascular health using standard general practice equipment and procedures (i.e. non-invasive methods) will also be conducted. Anyone discovered to be suffering from a cardiovascular ailment not previously identified and diagnosed will be excluded from the study.
Following these general examinations and the more extensive examinations of cardiovascular health, specifically identified areas in participants' mouths will be variously swabbed or scraped to obtain bacteria samples, and levels of bacteria in these areas and in the mouth as a whole will be measured using a variety of techniques. If necessary, the bacteria collected through this direct methodology will be cultured in an appropriate lab setting using standard equipment, with twenty-four hours being sufficient time for the culture to grow to be identifiable in most instances. Examination of bacteria types, growth patterns in the mouth, and correlation with cardiovascular disease will be identifiable with the data collected via these methods, enabling appropriate analysis and a determination of correlation.
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