Actively Recruiting

Age: 7Years - 100Years
All Genders
Healthy Volunteers
NCT01568697

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

Led by National Institute of Dental and Craniofacial Research (NIDCR) · Updated on 2026-05-07

700

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: \- Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of an individual handles these bacteria. Researchers want to look at the oral bacteria and genetic immune problems of different people to learn how these affect gum disease and other conditions of the mouth. Objectives: \- To study how immune system problems may lead to problems in the mouth, including gum disease. Eligibility: * Children and adults at least 7 years of age who have genetic problems with their immune system. * Healthy adults that have periodontal disease * Health adults that do not have periodontal disease Design: * This study will involve a screening visit and a study visit. * Participants will be screened with a medical history, blood work and a full oral and dental exam, including dental x-rays and photos. * The study visit will involve collection of blood, urine, and other samples, including saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional oral and dental exams will be performed. Participants will also answer questions about any current medical or dental problems.

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a known 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 those with severe periodontitis willing to allow genetic testing
  • Healthy volunteers aged 18 years or older
  • Healthy volunteers willing to allow genetic testing
  • Healthy volunteers with at least 20 natural teeth
  • For natural history phase: diagnosed genetic immune defect with oral disease (mainly periodontitis)
  • For standard care treatment: active untreated gum disease with signs of tissue inflammation and bone loss of 5 mm or more
Not Eligible

You will not qualify if you...

  • History of Hepatitis B or C
  • History of HIV
  • Prior radiation therapy to the head or neck
  • Active cancer except local skin basal or squamous cell carcinoma
  • Treatment with systemic chemotherapy or radiation within 5 years
  • Pregnant or breastfeeding
  • Participation considered unsafe by the study doctor or primary medical team
  • For healthy volunteers: diabetes or HbA1C over 6%
  • More than 3 hospitalizations in the last 3 years
  • Autoimmune disorders like Lupus or Rheumatoid arthritis
  • Use of systemic antibiotics, corticosteroids, immunosuppressants, cytokine therapy, methotrexate, or high-dose probiotics in the 3 months before enrollment
  • Use of tobacco products including e-cigarettes within 1 year
  • Unwilling to consent to oral biopsy
  • NIH employees in the study unit or research core team
  • For standard care treatment: mild or inactive disease, urgent complex dental needs, or need for advanced prosthetic dental work

AI-Screening

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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.

CONTACT

N

Niki M Moutsopoulos, D.D.S.

CONTACT

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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