NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Oral Microbial and Immunological Characterization of Patients with Immune Dysfunction

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-D-0100

Sponsoring Institute

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 7
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Microbiome;
Periodontitis;
Oral Mucosal Immunity;
Oral Infection

Recruitment Keyword(s)

Immune Disorder;
Periodontal Disease;
Gum Disease;
Healthy Volunteer;
HV

Condition(s)

Immunosuppression;
Periodontal Disease;
Healthy Subjects;
Healthy Volunteer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Dental and Craniofacial Research

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.

--Back to Top--

Eligibility

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)


--Back to Top--

Citations:

Rescigno M. The intestinal epithelial barrier in the control of homeostasis and immunity. Trends Immunol. 2011 Jun;32(6):256-64. Epub 2011 May 11.

Novak N, Haberstok J, Bieber T, Allam JP. The immune privilege of the oral mucosa. Trends Mol Med. 2008 May;14(5):191-8. Epub 2008 Apr 7.

Maslowski KM, Mackay CR. Diet, gut microbiota and immune responses. Nat Immunol. 2011 Jan;12(1):5-9.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Niki M. Moutsopoulos, D.D.S.
National Institute of Dental And Craniofacial Research (NIDCR)
BG 30 RM 327
30 CONVENT DR
BETHESDA MD 20814
(301) 435-7182
nmoutsop@mail.nih.gov

Laurie D. Brenchley
National Institute of Dental And Craniofacial Research (NIDCR)
National Institutes of Health
Building 10
Room 1N117
10 Center Drive
Bethesda, Maryland 20892
(301) 451-2551
laurie.brenchley@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01568697

--Back to Top--