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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01568697
Recruitment Status : Recruiting
First Posted : April 2, 2012
Last Update Posted : March 25, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Brief Summary:


- 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.


- To study how immune system problems may lead to problems in the mouth, including gum disease.


  • 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


  • 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.

Condition or disease
Immunosuppression Periodontal Disease Healthy Subjects Healthy Volunteer

Detailed Description:

This protocol is a cross sectional study designed to investigate the clinical, microbiologic, and immunologic consequences of immune dysfunction (particularly dysfunction due to primary immune defects) in the oral cavity. The hypothesis is that systemic immune dysfunction, attributed to monogenic immune defects in most of our populations of interest, will lead to alterations in the local immune response and microbial colonization and ultimately predispose to susceptibility to oral infections and inflammatory conditions. Of particular interest to this protocol is the susceptibility of select patient populations with immune dysfunction to periodontal disease. Whereas patients with hyper-immunoglobulin E syndrome (HIES) are an important focus of this research, enrollment will be open to a broader population, including monogenic immune defects such as leukocyte adhesion deficiency-1 (LAD-1), chronic granulomatous disease (CGD), as well as patients with defects in cytokine signaling.

For inclusion in this study, ID subjects must have a current diagnosis of a primary immune defect, and be enrolled in an NIH protocol that is following their medical issues and through which they are required to get a dental consult. Data from the dental consult, collected under the parent protocol, will be analyzed through this protocol to assess the type and extent of oral manifestation in patients with these immune defects. In addition to the information collected as part of the consult, subjects will undergo sampling for oral fluids, microbes, and blood sampling. Each patient subject 18 years of age or older will also undergo an oral biopsy. Systemically healthy volunteer subjects will be screened and classified as with/without periodontitis. Healthy volunteers will be clinically evaluated and enrolled for a single visit, at which they will undergo oral fluid/microbe/tissue/blood sampling/oral biopsy for research purposes.

The primary aim of this protocol is to use modern methodologies to characterize the immune response and microbial colonization in the oral cavity in health and patients with primary immune defects. By particularly studying subjects with monogenic immune defects, we aim to increase the understanding of the role of specific immune molecules and pathways in the balance of host/microbial interactions on mucosal surfaces such as the oral cavity.

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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction
Actual Study Start Date : October 5, 2012

Primary Outcome Measures :
  1. Clinical Intraoral characterization [ Time Frame: Ongoing ]
  2. Characterize the immune response in the oral cavity of patients with monogenic immune defects [ Time Frame: Ongoing ]
  3. Characterize the microbiome in the oral cavity of patients with monogenic immune defects [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. Validate methodologies for measuring levels of immune mediators in oral fluids [ Time Frame: Ongoing ]
  2. Establish normative values of immune mediators in oral fluids and tissues [ Time Frame: Ongoing ]
  3. Assay development [ Time Frame: Ongoing ]
  4. Initial data from this study may generate new hypotheses for investigation as part of this study. [ Time Frame: Ongoing ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Patients with Immune Dysfunction:

-Patients with an established monogenic immune defect will be eligible for screening inclusion under this protocol.

  • Diagnosis of monogenic immune defect
  • Greater than or equal to 7 years old
  • Be concurrently enrolled in a protocol at NIH that is following the medical condition of the patient and under which a dental consult was requested
  • Willing to allow genetic testing

Healthy Volunteer Subjects:

  • In good general health
  • Greater than or equal to 18 years old
  • Willing to allow genetic testing
  • Have a minimum of 20 natural teeth

Healthy Volunteer Subjects with Severe Periodontitis 3.2.3 (treatment group) additional criteria:

  • Active untreated disease (visible signs of tissue inflammation including erythema/edema, generalized bleeding upon probing)
  • Periodontal disease defined as generalized measured bone loss of >5mm as measured on periodontal exam.


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 (greater than or equal to 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 Healthy Volunteers with Periodontal Disease:

  • 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 advance periodontal care (including bone/tissue grafts/implants)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01568697

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Contact: Laurie D Brenchley (301) 451-2551
Contact: Niki M Moutsopoulos, D.D.S. (301) 435-7182

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: Niki M Moutsopoulos, D.D.S. National Institute of Dental and Craniofacial Research (NIDCR)

Additional Information:
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Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR) Identifier: NCT01568697     History of Changes
Other Study ID Numbers: 120100
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 20, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Oral Microbiome
Oral Mucosal Immunity
Oral Infection
Immune Disorder
Periodontal Disease
Gum Disease
Healthy Volunteer
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases