RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction

Quick Facts

Study Start:2012-10-05
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01568697

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with a genetic immune defect
  2. * Willing to allow genetic testing
  3. * 7 years old
  4. * History of severe periodontitis prior to age \<30
  5. * Willing to allow genetic testing
  6. * In good general health
  7. * In good general health
  8. * Willing to allow genetic testing
  9. * Have a minimum of 20 natural teeth
  10. * Diagnosis of genetic immune defect
  11. * Presence of oral manifestation (primarily periodontitis)
  12. * Active untreated disease (visible signs of tissue inflammation including erythema/edema, generalized bleeding upon probing)
  13. * Periodontal disease defined as bone loss of \>=5mm as measured on periodontal exam.
  1. * History of Hepatitis B or C
  2. * History of HIV
  3. * Prior radiation therapy to the head or neck
  4. * Have an active malignancy except localized basal or squamous cell carcinoma of the skin
  5. * Have been treated with systemic chemotherapeutics or radiation therapy within 5 years of screening
  6. * Pregnant or lactating
  7. * 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.
  8. * Diagnosis of diabetes and/or HbA1C level \>6%
  9. * More than 3 hospitalizations in the last 3years
  10. * Have an autoimmune disorder such as Lupus, Rheumatoid arthritis, etc.
  11. * In the 3 months before study enrollment, have used any of the following:
  12. * Systemic (intravenous, intramuscular, or oral) antibiotics
  13. * Oral, intravenous, intramuscular, intranasal, or inhaled corticosteroids or other immunosuppressants (e.g., cyclosporine)
  14. * Cytokine therapy
  15. * Methotrexate or immunosuppressive chemotherapeutic agents
  16. * 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
  17. * Have used tobacco products (including e-cigarettes) within 1 year of screening
  18. * Unwillingness to consent to oral biopsy
  19. * NIH employees working in the Oral Immunity and Inflammation Unit and members of the Clinical Research Core Team will not be eligible for enrollment.
  20. * Mild/moderate non-active disease (absence of active inflammatory lesions)
  21. * Subjects with urgent/complex restorative needs (ex. severe active carious lesions/fractured dentition)
  22. * Subjects in need for advanced prosthetic needs (including implants and restorations)

Contacts and Locations

Study Contact

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

Principal Investigator

Niki M Moutsopoulos, D.D.S.
PRINCIPAL_INVESTIGATOR
National Institute of Dental and Craniofacial Research (NIDCR)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

  • Niki M Moutsopoulos, D.D.S., PRINCIPAL_INVESTIGATOR, National Institute of Dental and Craniofacial Research (NIDCR)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-10-05
Study Completion DateN/A

Study Record Updates

Study Start Date2012-10-05
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Microbiome
  • Periodontitis
  • Oral Mucosal Immunity
  • Oral Infection
  • Natural History
  • Immune Disorder
  • Periodontal Disease
  • Gum Disease
  • Healthy Volunteer
  • HV

Additional Relevant MeSH Terms

  • Immunosuppression
  • Periodontal Disease
  • Healthy Subjects
  • Healthy Volunteer