Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
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|ClinicalTrials.gov Identifier: NCT01568697|
Recruitment Status : Recruiting
First Posted : April 2, 2012
Last Update Posted : January 7, 2019
|First Submitted Date||March 30, 2012|
|First Posted Date||April 2, 2012|
|Last Update Posted Date||January 7, 2019|
|Study Start Date||March 13, 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01568697 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)|
|Official Title||Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction|
- 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.
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 Design||Observational Model: Case-Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Patients with Immune Dysfunction:
-Patients with an established monogenic immune defect will be eligible for screening inclusion under this protocol.
Healthy Volunteer Subjects:
Healthy Volunteer Subjects with Severe Periodontitis 3.2.3 (treatment group) additional criteria:
Additional Exclusions for Healthy Volunteers:
Additional Exclusions for Healthy Volunteers with Periodontal Disease:
|Ages||7 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||120100
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )|
|Study Sponsor||National Institute of Dental and Craniofacial Research (NIDCR)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 18, 2018|