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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.
 
ClinicalTrials.gov Identifier: NCT01568697
Recruitment Status : Recruiting
First Posted : April 2, 2012
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Brief Summary:

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.

Condition or disease
Immunosuppression Periodontal Disease Healthy Subjects Healthy Volunteer

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction
Actual Study Start Date : October 5, 2012

Group/Cohort
Healthy Volunteers
Healthy volunteers (with/without periodontal disease)
Immune deficient patients
Subjects with known genetic immune deficiency
Subjects with severe periodontitis suspected genetic etiology
Subjects with severe periodontitis of suspected genetic etiology and their family members



Primary Outcome Measures :
  1. Clinical Intraoral characterization (i.e., presence and severity of periodontitis). [ Time Frame: 15 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 defects [ Time Frame: 15 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.

  3. Characterize the microbiome in the oral cavity of patients with genetic immune defects [ Time Frame: 15 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.


Secondary Outcome Measures :
  1. Assay development/validation for the study of tissue immunity and microbiome characterization 2. Establishment of normative values for immune mediators and microbial elements at the oral cavity [ Time Frame: 15 years ]
    Validate methodologies for measuring levels of immune mediators in oral fluids-Establish normative values of immune mediators in oral fluids and tissues-Assay development; Develop new methodologies to study pathways of the immune response in the oral cavity-Assay development: Develop new methodologies to study the microbiome in the oral cavity



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
Sampling Method:   Non-Probability Sample
Study Population
This is a cross sectional/natural history protocol designed to investigate the clinical, microbiologic, and immunologic consequences of genetic immune defects in the oral cavity. Three cohorts will be enrolled 1) subjects with genetic immune defects 2) subjects with severe periodontitis of suspected genetic etiology and their family members 3) healthy volunteers (with/without periodontal disease). The study involves detailed oral clinical and radiographic evaluations, standard laboratory testing and research sampling of blood and oral samples. All evaluations are performed at the NIH Clinical Center.
Criteria
  • INCLUSION CRITERIA:

Patients with Genetic Immune Defects:

-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

Severe Periodontitis of Suspected Genetic Etiology and Family Members:

  • History of severe periodontitis prior to age <30
  • Willing to allow genetic testing
  • Greater than or equal to 7 years old
  • In good general health

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

Inclusion Criteria for Natural History phase, all subjects:

  • Diagnosis of genetic immune defect
  • Presence of oral manifestation (primarily periodontitis)

Inclusion 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 (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 ClinicalTrials.gov identifier (NCT number): NCT01568697


Contacts
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Contact: Laurie D Brenchley (301) 451-2551 laurie.brenchley@nih.gov
Contact: Niki M Moutsopoulos, D.D.S. (301) 435-7182 nmoutsop@mail.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Niki M Moutsopoulos, D.D.S. National Institute of Dental and Craniofacial Research (NIDCR)

Additional Information:
Publications:
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Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT01568697    
Other Study ID Numbers: 120100
12-D-0100
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 7, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Microbiome
Periodontitis
Oral Mucosal Immunity
Oral Infection
Immune Disorder
Periodontal Disease
Gum Disease
Healthy Volunteer
HV
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases