Join Clinical Trials for Gum Disease
Gum disease (or periodontal disease) is extremely common in the United States, and affects many, many adults. The term gum disease describes a number of conditions that adversely affect the gums and which occur when the bacteria in the mouth accumulate and form plaque.
When plaque hardens, it forms tartar, which if not removed, continues to accumulate and cause increasing damage to the gums and teeth. Gum disease can range in severity from mild gum inflammation (a condition known as gingivitis) to serious gum disease that leads to severe damage to the tissues and bones that support the teeth (periodontitis). In those cases, teeth are often lost as a result.
Fortunately, if identified early, gum disease can be stopped from progressing by controlling the bacterial growth within the mouth. In addition, good oral care practices (such as brushing and flossing) are essential components of effective treatment as well. In addition, various dental procedures that deeply clean plaque from below and above the gum line can help remove bacteria.
Medications may also help in addition to intensive oral treatments, and in the most severe cases, surgery may be required to repair damaged bone and tissue.
Research related to gum disease is focused on developing new and better ways to prevent, diagnose, and treat gingivitis and periodontitis. Additionally, a current topic of interest to many researchers is exploring if any association exists between gum disease and adverse health conditions, and events such as heart disease, diabetes, and certain pregnancy complications.
What Will Gum Disease Clinical Trials Be Like?
The types of tests and assessments used in gum disease clinical trials will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures which may be incorporated for use in clinical trials:
- Detailed exam of the teeth, mouth, and gums.
- Detailed review of your medical history.
- Study dentist or doctor may use a metal probe to measure the depth of the narrow grooves between your gums and your teeth.
- Blood tests to look for indications of an underlying disease or condition.
- Dental x-rays
- You may be asked to avoid eating, drinking, chewing gum, smoking, and brushing your teeth for a specific period of time before any study-related evaluations.
- You may be asked to maintain a log of your diet, as well as behaviors such as smoking, gum chewing, use of mints and mouthwash.
- You may be asked to complete brief questionnaires to evaluate your quality of life, pain level, and/or level of depression and/or anxiety.
- Swab of the inner cheeks, teeth, gums and/or tongue to obtain bacteria samples for analysis.
Typical Gum Disease Clinical Trial Protocol:
Specific examples of clinical trials for gum disease might include the following:
- A randomized clinical trial in which treatment for periodontitis with a single antibiotic is compared to treatment with a combination of two antibiotics to determine which treatment is a) more effective at repairing damage done by periodontitis, b) which results in fewer side effects, and c) which is subjectively preferred by patients.
- A randomized clinical trial that investigates the effect of obesity on non-surgical treatment methods for periodontitis. In such a study, patients would be randomly assigned to receive standard treatment with scaling and root planning plus the addition of an antibiotic, or standard treatment plus placebo.
- A long-term study in which individuals with periodontitis and a diagnosis of coronary heart disease will be followed for two years to observe the occurrence of cardiovascular-related death, heart attack, or stroke. Oral bacterial samples would also be taken from the patients at the start of the study and then later analyzed to see if there was any correlation between the number and types of bacteria present and patient outcomes.
- A clinical trial in which pregnant women undergo oral examination at 20 weeks gestation to determine the presence of periodontal disease and to submit a blood sample for analysis of various bacterial and inflammatory markers. The women would then be followed until delivery and the researchers would note any adverse pregnancy-related outcomes (such as preterm delivery or high blood pressure). At the time of delivery, women would also undergo another periodontal exam and provide an additional blood sample for comparison to the original samples.
A brief word about randomized trials and placebos:
Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.
On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the second clinical trial example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.
Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.
In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.
It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.
Trial Eligibility and Medical Information Needed:
The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials. Examples of information you may want to have on hand include the following:
- Your history of gum and/or tooth disease and any specific diagnoses (i.e., gingivitis)
- Your history of treatment for gum and/or tooth disease.
- Your prior and current diagnoses of any health conditions or diseases.
- Your current medications (including vitamins and other dietary supplements)
Suggested Search Terms:
“gum disease prevention,” “gum disease management,” “gum disease treatment,” “gum disease diet,” “gum disease infection,” “gum disease diabetes,” “gum disease heart disease,” “gum disease pregnancy,” and “pediatric gum disease.”
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