NCT01568697 · National Institute of Dental and Craniofacial Research (NIDCR)
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Bethesda, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations