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 : March 14, 2018
- 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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||650 participants|
|Official Title:||Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction|
|Study Start Date :||March 13, 2012|
- Clinical Intraoral characterization [ Time Frame: Ongoing ]
- Characterize the immune response in the oral cavity of patients with monogenic immune defects [ Time Frame: Ongoing ]
- Characterize the microbiome in the oral cavity of patients with monogenic immune defects [ Time Frame: Ongoing ]
- Validate methodologies for measuring levels of immune mediators in oral fluids [ Time Frame: Ongoing ]
- Establish normative values of immune mediators in oral fluids and tissues [ Time Frame: Ongoing ]
- Assay development [ Time Frame: Ongoing ]
- Initial data from this study may generate new hypotheses for investigation as part of this study. [ Time Frame: Ongoing ]
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
|Contact: Laurie D Brenchley||(301) firstname.lastname@example.org|
|Contact: Niki M Moutsopoulos, D.D.S.||(301) email@example.com|
|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 Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Niki M Moutsopoulos, D.D.S.||National Institute of Dental and Craniofacial Research (NIDCR)|