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Studying Oral Bacteria and Immune System Problems in Gum Disease

This study aims to understand how problems with your immune system and the bacteria in your mouth contribute to gum disease (periodontitis). Researchers want to look at people with known genetic immune defects, those with severe gum disease that might have a genetic cause, and healthy volunteers. By studying these groups, they hope to learn how genetic immune problems can lead to changes in the mouth's immune response and bacteria, making people more likely to get oral infections. The goal is to better understand why some people develop gum disease and other mouth conditions.

Study design
This is an observational study with a planned enrollment of 700 participants. It is designed to investigate the clinical, microbiologic, and immunologic consequences of genetic immune defects in the oral cavity.
What's involved
Participants will be evaluated and screened for gum disease, genetic defects, and have samples taken for studies in oral immunity and the microbiome. Some participants with genetic immune defects and oral disease may be followed clinically over time.
Compensation
Not stated in the trial record.
Follow-up
Participants will be characterized for their oral microbiome, immune response, and clinical intraoral features at 25 years.

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NCT01568697

Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)

Recruiting
Not specifiedAges 7+Observational
National Institute of Dental and Craniofacial Research (NIDCR)
~700 participants
Updated 2026-08-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
3. Characterize the microbiome in the oral cavity of patients with genetic immune defects
Measured over 25 years
+2 more outcomes measured

Conditions

Immunosuppression
Periodontal Disease
Healthy Subjects
Healthy Volunteer

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Immunosuppressive TherapyPeriodontitis

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Niki M Moutsopoulos, D.D.S. · PRINCIPAL_INVESTIGATOR · National Institute of Dental and Craniofacial Research (NIDCR)

Who to contact

Laurie D Brenchley, R.D.H.
[email protected]
(301) 451-2551
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosed with a genetic immune defect
Willing to allow genetic testing
7 years old
History of severe periodontitis prior to age \<30
Willing to allow genetic testing
\>=7 years old
In good general health
Willing to allow genetic testing
\>=7 years old
In good general health
\>=18 years old
Willing to allow genetic testing
Have a minimum of 20 natural teeth
Diagnosis of genetic immune defect
Presence of oral manifestation (primarily periodontitis)
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

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.
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.
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)

What this trial measures

  • 3. Characterize the microbiome in the oral cavity of patients with genetic immune defects25 years

    The primary clinical endpoints of the study are severity and types of oral disease: specifically for periodontal disease, mean PD, mean CAL, proportion of sites with PD \>5 mm, and proportion of subjects with BOP, proportion of patient with other inflammatory conditions or infections of the oral cavity by immune disorder.Characterization of the oral microbiome in patients with monogenic immune defects. Immunologic endpoints: types and levels of immune mediators in the saliva, GCF, oral tissues, and/or blood.

  • 2. Characterize the immune response in the oral cavity of patients with genetic immune defects25 years

    The primary clinical endpoints of the study are severity and types of oral disease: specifically for periodontal disease, mean PD, mean CAL, proportion of sites with PD \>5 mm, and proportion of subjects with BOP, proportion of patient with other inflammatory conditions or infections of the oral cavity by immune disorder.Characterization of the oral microbiome in patients with monogenic immune defects. Immunologic endpoints: types and levels of immune mediators in the saliva, GCF, oral tissues, and/or blood.

  • 1. Clinical intraoral characterization (i.e., presence and severity of periodontitis).25 years

    The primary clinical endpoints of the study are severity and types of oral disease: specifically for periodontal disease, mean PD, mean CAL, proportion of sites with PD \>5 mm, and proportion of subjects with BOP, proportion of patient with other inflammatory conditions or infections of the oral cavity by immune disorder.Characterization of the oral microbiome in patients with monogenic immune defects. Immunologic endpoints: types and levels of immune mediators in the saliva, GCF, oral tissues, and/or blood.