Investigating the link between oral bacteria and immune system issues in gum disease
Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction
This study is trying to see how genetic immune problems affect gum disease and oral health by looking at people with these issues, those with severe gum disease, and healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 7 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | radiation, Methotrexate |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01568697 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how genetic immune defects influence the development of gum disease and other oral conditions. Participants will include individuals with known genetic immune defects, those with severe periodontitis, and healthy volunteers. The study will involve screening visits that include medical history, blood work, and oral examinations to assess the presence and severity of periodontal disease and genetic factors. The goal is to understand the relationship between immune responses, oral microbiome, and susceptibility to oral infections.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 7 and older with genetic immune defects, those with severe periodontitis, and healthy volunteers.
Not a fit: Patients without genetic immune defects or those who do not have periodontal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of gum disease in patients with genetic immune defects.
How similar studies have performed: While this study explores a specific genetic aspect of gum disease, similar studies have shown promising results in understanding the microbiome's role in oral health.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Niki M Moutsopoulos, D.D.S. — National Institute of Dental and Craniofacial Research (NIDCR)
- Study coordinator: Laurie D Brenchley, R.D.H.
- Email: laurie.brenchley@nih.gov
- Phone: (301) 451-2551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.