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Scientists dig into mouth bacteria to unlock immune secrets

NCT ID NCT01568697

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2012

Lead sponsor

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

7 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.