ImmunosuppressionNCT01568697
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
An observational study of Immunosuppression and Periodontal Disease, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunosuppression, Periodontal Disease, Healthy Subjects
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2012to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Subjects with Genetic Immune Defects:
- Patients with a known genetic immune defect will be eligible for screening inclusion under this protocol.
- Diagnosed with a genetic immune defect
- Willing to allow genetic testing
- 7 years old
- Subjects with Severe Periodontitis of Suspected Genetic Etiology:
Show all 23Show fewer
- History of severe periodontitis prior to age <30
- Willing to allow genetic testing
- ->=7 years old
- In good general health
- Family members of Subjects with Severe Periodontitis of Suspected Genetic Etiology:
- -Willing to allow genetic testing
- ->=7 years old
- Healthy Volunteer Subjects (with/without periodontitis):
- In good general health
- ->=18 years old
- Willing to allow genetic testing
- Have a minimum of 20 natural teeth
- Diagnosis of genetic immune defect
- Presence of oral manifestation (primarily periodontitis)
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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 (>=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 Standard of Care Treatment at NIH:
- 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 advanced prosthetic needs (including implants and restorations)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction
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.
Read more
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.
Read the detailed description
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. The hypothesis is that genetic immune defects will lead to alterations in the local immune response and microbial colonization and ultimately predispose to susceptibility to oral infections and inflammatory conditions.
In the cross-sectional phase the following individuals will be enrolled, evaluated and screened for presence and severity of periodontitis, presence of a genetic defects and sampled for studies in oral immunity and microbiome: 1) individuals diagnosed with genetic immune defects 2) individuals with severe periodontitis of suspected genetic etiology and their family members 3) healthy volunteers. Subjects identified with a genetic immune defect and with presence of oral disease (primarily periodontitis) may enter the natural history phase of the study to be clinically followed at the National Institutes of Health (NIH) over time. This protocol aims to determine whether specific genetic immune defects will predispose to oral disease (primarily periodontitis) and to better understand consequences of immune deficiency on the oral immune response and microbiome.
Primary Objectives
- Investigate the degree, scope, etiology and natural history of oral manifestations in patients with genetic immune defects.
- Characterize the immune response in the oral cavity of patients with genetic immune defects.
- Characterize the microbiome in the oral cavity of patients with genetic immune defects.
Secondary Objectives
- Assay development/validation for the study of tissue immunity and microbiome characterization
- Establishment of normative values for immune mediators and microbial elements at the oral cavity
Study Population (s)
The study population will include:
- Subjects with genetic immune defects
- Subjects with severe periodontitis of suspected genetic etiology and their family members
- Healthy volunteers (with/without periodontal disease)
Design
This is a cross-sectional/natural history study for the evaluation of clinical, immunologic, and microbiologic oral manifestations (primarily periodontitis) in patients diagnosed with genetic immune defects or those with severe periodontitis of suspected genetic etiology and healthy volunteer subjects.
Cross Sectional Phase: Three groups of subjects will be enrolled in the cross-sectional phase of the study 1) individuals diagnosed with genetic immune defects 2) individuals with severe periodontitis of suspected genetic etiology and their family members that include parents or siblings 3) healthy volunteers (with/without periodontal disease). All groups will be evaluated for oral disease (periodontitis) may be and sampled for oral immunity, systemic immunity and microbiome characterization. Individuals with severe periodontitis in the presence/absence of a genetic defect may be offered the option of receiving standard of care inflammatory control periodontal treatment at NIH without travel compensation, following the cross-sectional portion of the study. Family members (parents or siblings) of individuals with periodontal disease of suspected genetic may be asked to participate in this study. During the course of genetic testing, family members may be enrolled in the cross sectional phase of the study for phenotyping and genetic testing.
Natural History Phase: Subjects identified with a genetic defect with the presence of oral disease may enroll in the natural history phase of the study to be followed clinically over time.
Primary Outcome Measures
- Clinical intraoral characterization (i.e., presence and severity of periodontitis).
- Characterize the immune response in the oral cavity of patients with genetic immune defects
- Characterize the microbiome in the oral cavity of patients with genetic immune defects
Secondary Outcome Measures
- Assay development/validation for the study of tissue immunity and microbiome characterization
- Establishment of normative values for immune mediators and microbial elements at the oral cavity
Exploratory Outcome Measures
Initial data from this study may generate new hypotheses for investigation as part of this study.
- Keywords
- Microbiome, Periodontitis, Oral Mucosal Immunity, Oral Infection, Natural History, Immune Disorder, Periodontal Disease, Gum Disease, Healthy Volunteer, HV
- Medical subject headings
- Periodontal Diseases, Periodontitis, Immune System Diseases, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers (with/without periodontal disease) | |
| Immune deficient patients | Subjects with known genetic immune deficiency | |
| Subjects with severe periodontitis of suspected genetic etiology and their family | Subjects with severe periodontitis of suspected genetic etiology and their family members |
What is being measured
The primary outcome is the main question the study is designed to answer.
3. Characterize the microbiome in the oral cavity of patients with genetic immune defects
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.
Measured: 25 years
2. Characterize the immune response in the oral cavity of patients with genetic immune defects
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.
Measured: 25 years
1. Clinical intraoral characterization (i.e., presence and severity of periodontitis).
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.
Measured: 25 years
Secondary outcomes (2)
2. Establishment of normative values for immune mediators and microbial elements at the oral cavity
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
Measured: 25 years
1. Assay development/validation for the study of tissue immunity and microbiome characterization
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
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study start5 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Niki M Moutsopoulos, D.D.S., Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568697
- Sponsor's protocol ID
- 120100
- Other IDs
- 12-D-0100
- Status last verified
- 9 Oct 2026
- First submitted
- 30 Mar 2012
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rescigno M. The intestinal epithelial barrier in the control of homeostasis and immunity. Trends Immunol. 2011 Jun;32(6):256-64. doi: 10.1016/j.it.2011.04.003. Epub 2011 May 11.
PubMed 21565554Novak N, Haberstok J, Bieber T, Allam JP. The immune privilege of the oral mucosa. Trends Mol Med. 2008 May;14(5):191-8. doi: 10.1016/j.molmed.2008.03.001. Epub 2008 Apr 7.
PubMed 18396104Maslowski KM, Mackay CR. Diet, gut microbiota and immune responses. Nat Immunol. 2011 Jan;12(1):5-9. doi: 10.1038/ni0111-5.
PubMed 21169997Williams DW, Greenwell-Wild T, Brenchley L, Dutzan N, Overmiller A, Sawaya AP, Webb S, Martin D; NIDCD/NIDCR Genomics and Computational Biology Core; Hajishengallis G, Divaris K, Morasso M, Haniffa M, Moutsopoulos NM. Human oral mucosa cell atlas reveals a stromal-neutrophil axis regulating tissue immunity. Cell. 2021 Jul 22;184(15):4090-4104.e15. doi: 10.1016/j.cell.2021.05.013. Epub 2021 Jun 14.
PubMed 34129837
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction
- ClinicalTrials.gov ID
- NCT01568697
- Acronym / sponsor ID
- 120100
- Keywords
- Microbiome, Periodontitis, Oral Mucosal Immunity, Oral Infection, Natural History, Immune Disorder, Periodontal Disease, Gum Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 5 Oct 2012 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The hypothesis is that genetic immune defects will lead to alterations in the local immune response and microbial colonization and ultimately predispose to susceptibility to oral infections and inflammatory conditions.
In the cross-sectional phase the following individuals will be enrolled, evaluated and screened for presence and severity of periodontitis, presence of a genetic defects and sampled for studies in oral immunity and microbiome: 1) individuals diagnosed with genetic immune defects 2) individuals with severe periodontitis of suspected genetic etiology and their family members 3) healthy volunteers. Subjects identified with a genetic immune defect and with presence of oral disease (primarily periodontitis) may enter the natural history phase of the study to be clinically followed at the National Institutes of Health (NIH) over time. This protocol aims to determine whether specific genetic immune defects will predispose to oral disease (primarily periodontitis) and to better understand consequences of immune deficiency on the oral immune response and microbiome.
Primary Objectives
- Investigate the degree, scope, etiology and natural history of oral manifestations in patients with genetic immune defects.
- Characterize the immune response in the oral cavity of patients with genetic immune defects.
- Characterize the microbiome in the oral cavity of patients with genetic immune defects.
Secondary Objectives
- Assay development/validation for the study of tissue immunity and microbiome characterization
- Establishment of normative values for immune mediators and microbial elements at the oral cavity
Study Population (s)
The study population will include:
- Subjects with genetic immune defects
- Subjects with severe periodontitis of suspected genetic etiology and their family members
- Healthy volunteers (with/without periodontal disease)
Design
This is a cross-sectional/natural history study for the evaluation of clinical, immunologic, and microbiologic oral manifestations (primarily periodontitis) in patients diagnosed with genetic immune defects or those with severe periodontitis of suspected genetic etiology and healthy volunteer subjects.
Cross Sectional Phase: Three groups of subjects will be enrolled in the cross-sectional phase of the study 1) individuals diagnosed with genetic immune defects 2) individuals with severe periodontitis of suspected genetic etiology and their family members that include parents or siblings 3) healthy volunteers (with/without periodontal disease). All groups will be evaluated for oral disease (periodontitis) may be and sampled for oral immunity, systemic immunity and microbiome characterization. Individuals with severe periodontitis in the presence/absence of a genetic defect may be offered the option of receiving standard of care inflammatory control periodontal treatment at NIH without travel compensation, following the cross-sectional portion of the study. Family members (parents or siblings) of individuals with periodontal disease of suspected genetic may be asked to participate in this study. During the course of genetic testing, family members may be enrolled in the cross sectional phase of the study for phenotyping and genetic testing.
Natural History Phase: Subjects identified with a genetic defect with the presence of oral disease may enroll in the natural history phase of the study to be followed clinically over time.
Primary Outcome Measures
- Clinical intraoral characterization (i.e., presence and severity of periodontitis).
- Characterize the immune response in the oral cavity of patients with genetic immune defects
- Characterize the microbiome in the oral cavity of patients with genetic immune defects
Secondary Outcome Measures
- Assay development/validation for the study of tissue immunity and microbiome characterization
- Establishment of normative values for immune mediators and microbial elements at the oral cavity
Exploratory Outcome Measures
Initial data from this study may generate new hypotheses for investigation as part of this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy volunteers (with/without periodontal disease) |
| Immune deficient patients | – | –Subjects with known genetic immune deficiency |
| Subjects with severe periodontitis of suspected genetic etiology and their family | – | –Subjects with severe periodontitis of suspected genetic etiology and their family members |
Who may qualify
- Ages
- 7 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (23 listed)
- Patients with a known genetic immune defect will be eligible for screening inclusion under this protocol.
- Diagnosed with a genetic immune defect
- Willing to allow genetic testing
- History of severe periodontitis prior to age <30
- Willing to allow genetic testing
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3. Characterize the microbiome in the oral cavity of patients with genetic immune defects
Time frame: 25 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: 25 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.
1. Clinical intraoral characterization (i.e., presence and severity of periodontitis).
Time frame: 25 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 secondary outcomes
2. Establishment of normative values for immune mediators and microbial elements at the oral cavity
Time frame: 25 years
1. Assay development/validation for the study of tissue immunity and microbiome characterization
Time frame: 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 21565554Rescigno M. The intestinal epithelial barrier in the control of homeostasis and immunity. Trends Immunol. 2011 Jun;32(6):256-64. doi: 10.1016/j.it.2011.04.003. Epub 2011 May 11.
- Background: PubMed 18396104Novak N, Haberstok J, Bieber T, Allam JP. The immune privilege of the oral mucosa. Trends Mol Med. 2008 May;14(5):191-8. doi: 10.1016/j.molmed.2008.03.001. Epub 2008 Apr 7.
- Background: PubMed 21169997Maslowski KM, Mackay CR. Diet, gut microbiota and immune responses. Nat Immunol. 2011 Jan;12(1):5-9. doi: 10.1038/ni0111-5.
- Derived from this study: PubMed 34129837Williams DW, Greenwell-Wild T, Brenchley L, Dutzan N, Overmiller A, Sawaya AP, Webb S, Martin D; NIDCD/NIDCR Genomics and Computational Biology Core; Hajishengallis G, Divaris K, Morasso M, Haniffa M, Moutsopoulos NM. Human oral mucosa cell atlas reveals a stromal-neutrophil axis regulating tissue immunity. Cell. 2021 Jul 22;184(15):4090-4104.e15. doi: 10.1016/j.cell.2021.05.013. Epub 2021 Jun 14.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Immunosuppression
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
RecruitingObservational study
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Critically-ill Patients
RecruitingObservational study
Immune Biomarkers for Predicting Complications After Liver Transplantation
Liver Transplantation (LT), Immuno-suppression
Not yet recruitingPhase 2
Biomarker-guided Reduction of Immunosuppression in Liver Transplant Recipients (BRITRE)
Liver Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niki M Moutsopoulos, D.D.S. principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression and Periodontal Disease, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie D Brenchley, R.D.H. ((301) 451-2551, laurie.brenchley@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3. Characterize the microbiome in the oral cavity of patients with genetic immune defects (time frame: 25 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01568697, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.