Is NCT01568697 recruiting in Bethesda, MD?

Yes, NCT01568697 is currently recruiting participants at its Bethesda, MD location. This immunosuppression clinical trial is actively enrolling qualified participants.

How do I join the immunosuppression clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Immunosuppression Clinical Trial in Bethesda, MD

About This Immunosuppression Study in Bethesda

Background: \- Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of an individual handles these bacteria. Researchers want to look at the oral bacteria and genetic immune problems of different people to learn how these affect gum disease and other conditions of the mouth. Objectives: \- To study how immune system problems may lead to problems in the mouth, including gum disease. Eligibility: * Children and adults at least 7 years of age who have genetic problems with their immune system. * Healthy adults that have periodontal disease * Health adults that do not have periodontal disease Design: * This study will involve a screening visit and a study visit. * Participants will be screened with a medical history, blood work and a full oral and dental exam, including dental x-rays and photos. * The study visit will involve collection of blood, urine, and other samples, including saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional oral and dental exams will be performed. Participants will also answer questions about any current medical or dental problems.

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Who Can Participate

Inclusion Criteria

Subjects with Genetic Immune Defects: Patients with a known genetic immune defect will be eligible for screening inclusion under this protocol.

Diagnosed with a genetic immune defect

Willing to allow genetic testing

7 years old Subjects with Severe Periodontitis of Suspected Genetic Etiology:

History of severe periodontitis prior to age \<30

Willing to allow genetic testing -\>=7 years old

In good general health Family members of Subjects with Severe Periodontitis of Suspected Genetic Etiology: -Willing to allow genetic testing -\>=7 years old Healthy Volunteer Subjects (with/without periodontitis):

In good general health -\>=18 years old

Willing to allow genetic testing

Have a minimum of 20 natural teeth Inclusion Criteria for Natural History phase, all subjects:

Diagnosis of genetic immune defect

Presence of oral manifestation (primarily periodontitis) Criteria for standard of care treatment:

Active untreated disease (visible signs of tissue inflammation including erythema/edema, generalized bleeding upon probing)

Periodontal disease defined as bone loss of \>=5mm as measured on periodontal exam.

Exclusion Criteria

All Subjects:

History of Hepatitis B or C

History of HIV

Prior radiation therapy to the head or neck

Have an active malignancy except localized basal or squamous cell carcinoma of the skin

Have been treated with systemic chemotherapeutics or radiation therapy within 5 years of screening

Pregnant or lactating

If participation in the protocol would not be safe or in the subject s best interest in the opinion of either the PI or the primary medical team. Additional Exclusions for Healthy Volunteers:

Diagnosis of diabetes and/or HbA1C level \>6%

More than 3 hospitalizations in the last 3years

Have an autoimmune disorder such as Lupus, Rheumatoid arthritis, etc.

In the 3 months before study enrollment, have used any of the following:

Systemic (intravenous, intramuscular, or oral) antibiotics

Oral, intravenous, intramuscular, intranasal, or inhaled corticosteroids or other immunosuppressants (e.g., cyclosporine)

Cytokine therapy

Methotrexate or immunosuppressive chemotherapeutic agents

Large doses of commercial probiotics (\>=10\^8 colony-forming units or organisms per day); includes tablets, capsules, lozenges, chewing gum, or powders in which a probiotic is a primary component; ordinary dietary components such as fermented beverages/milks, yogurts, and foods do not apply

Have used tobacco products (including e-cigarettes) within 1 year of screening

Unwillingness to consent to oral biopsy

NIH employees working in the Oral Immunity and Inflammation Unit and members of the Clinical Research Core Team will not be eligible for enrollment. Additional Exclusions for Standard of Care Treatment at NIH:

Mild/moderate non-active disease (absence of active inflammatory lesions)

Subjects with urgent/complex restorative needs (ex. severe active carious lesions/fractured dentition)

Subjects in need for advanced prosthetic needs (including implants and restorations)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT01568697) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Immunosuppression Treatment Options in Bethesda, MD

If you're searching for immunosuppression treatment options in Bethesda, MD, this clinical trial (NCT01568697) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced immunosuppression specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all immunosuppression clinical trials near you to find additional studies recruiting in your area.

Immunosuppression Clinical Trial in Bethesda, MD

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