The intestinal epithelial barrier in the control of homeostasis and immunity.
Maria Rescigno
https://pubmed.ncbi.nlm.nih.gov/21565554Actively Recruiting
Age: 7Years - 100Years
All Genders
Healthy Volunteers
ID01568697
Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction
Led by National Institute of Dental and Craniofacial Research (NIDCR) · Updated on 2026-06-08
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how genetic problems with the immune system affect gum disease, also known as periodontitis, and other mouth conditions. The study aims to understand how immune defects influence the oral immune response and the types of bacteria in the mouth. This research includes people with genetic immune defects, those with severe periodontitis suspected to be genetic, their family members, and healthy volunteers. The study includes a cross-sectional phase where participants are screened and evaluated through medical history, blood tests, oral and dental exams, x-rays, and photos. Samples like blood, urine, saliva, plaque, and gum swabs are collected, with biopsies taken from abnormal tissue. Some participants with genetic immune defects and oral disease may enter a natural history phase for ongoing clinical follow-up. The study also offers standard periodontal treatment for severe periodontitis cases without travel compensation. Participants will undergo detailed assessments of their oral health, immune response, and oral microbiome. Researchers will measure the presence and severity of gum disease, immune system activity in the mouth, and the oral bacterial community. The study involves questionnaires about medical and dental history and may include genetic testing and family member participation. The total participation time varies and includes screening and study visits with ongoing monitoring for some participants.
CONDITIONS
Brief Title
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Who Can Participate
Age: 7Years - 100Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with a genetic immune defect
- Willing to allow genetic testing
- At least 7 years old
- History of severe periodontitis before age 30
- In good general health
- Family members of subjects with severe periodontitis willing to allow genetic testing
- Healthy volunteers with or without periodontitis
- Healthy volunteers must have at least 20 natural teeth and be at least 18 years old
- Diagnosis of genetic immune defect with oral disease for natural history phase
- Active untreated periodontal disease for standard of care treatment
You will not qualify if you...
- History of Hepatitis B or C
- History of HIV
- Prior radiation therapy to head or neck
- Active cancer except localized skin basal or squamous cell carcinoma
- Treatment with systemic chemotherapy or radiation within 5 years
- Pregnant or lactating
- Unsafe participation as judged by medical team
- Healthy volunteers with diabetes or HbA1C >6%
- More than 3 hospitalizations in last 3 years for healthy volunteers
- Autoimmune disorders like Lupus or Rheumatoid arthritis for healthy volunteers
- Use of systemic antibiotics, corticosteroids, immunosuppressants, cytokine therapy, methotrexate, or high-dose probiotics within 3 months before enrollment for healthy volunteers
- Tobacco use within 1 year for healthy volunteers
- Unwillingness to consent to oral biopsy
- NIH employees in Oral Immunity and Inflammation Unit or Clinical Research Core Team
- Mild/moderate non-active periodontal disease for standard treatment
- Urgent or complex restorative dental needs
- Need for advanced prosthetic dental treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 25 years
Participants are evaluated for the presence and severity of periodontitis and undergo sampling for oral immunity and microbiome characterization.
Initial evaluation visit with possible additional assessments depending on cohort assignment
Long-term Monitoring
Duration - Up to 25 years
Participants identified with a genetic immune defect and oral disease are followed clinically over time to observe the natural history of their condition.
Follow-up visits as scheduled for ongoing clinical assessments
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
L
Laurie D Brenchley, R.D.H.
N
Niki M Moutsopoulos, D.D.S.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
The immune privilege of the oral mucosa.
Natalija Novak, Jörg Haberstok, Thomas Bieber...
https://pubmed.ncbi.nlm.nih.gov/18396104Diet, gut microbiota and immune responses.
Kendle M Maslowski, Charles R Mackay
https://pubmed.ncbi.nlm.nih.gov/21169997Human oral mucosa cell atlas reveals a stromal-neutrophil axis regulating tissue immunity.
Drake Winslow Williams, Teresa Greenwell-Wild, Laurie Brenchley...
https://pubmed.ncbi.nlm.nih.gov/34129837