Scientists dig into mouth bacteria to unlock immune secrets
NCT ID NCT01568697
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 15 times
Summary
This study looks at how genetic immune system problems might lead to gum disease and other mouth issues. Researchers will collect samples like saliva, plaque, and blood from 700 people, including those with immune defects, healthy adults with gum disease, and healthy adults without it. The goal is to understand the link between oral bacteria and immune response, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 700 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2012
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This is a cross sectional/natural history protocol designed to investigate the clinical, microbiologic, and immunologic consequences of genetic immune defects in the oral cavity. Three cohorts will be enrolled 1) subjects with genetic immune defects 2) subjects with severe periodontitis of suspected genetic etiology and their family members 3) healthy volunteers (with/without periodontal disease). The study involves detailed oral clinical and radiographic evaluations, standard laboratory testing and research sampling of blood and oral samples. All evaluations are performed at the NIH Clinical Center.
- Ages
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7 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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