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Az ínybetegséggel (parodontitis) kapcsolatos szájbaktériumok és immunrendszeri problémák

2026. október 23. frissítette: National Institute of Dental and Craniofacial Research (NIDCR)

Immunműködési zavarban szenvedő betegek szájüregi mikrobiológiai és immunológiai jellemzése

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

700

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Név: Niki M Moutsopoulos, D.D.S.
Telefonszám: (301) 435-7182
E-mail: nmoutsop@mail.nih.gov

Tanulmányozza a kapcsolattartók biztonsági mentését

Név: Laurie D Brenchley, R.D.H.
Telefonszám: (301) 451-2551
E-mail: laurie.brenchley@nih.gov

Tanulmányi helyek

Egyesült Államok
- Maryland
  - Bethesda, Maryland, Egyesült Államok, 20892
    - Toborzás
    - National Institutes of Health Clinical Center
    - Kapcsolatba lépni:
      
      For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
      
      Telefonszám: TTY dial 711 800-411-1222
      
      E-mail: ccopr@nih.gov

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

7 év (Gyermek, Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

INCLUSION CRITERIA:

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:

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

Inclusion Criteria for Natural History phase, all subjects:

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.

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 (>=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)

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: CASE_CONTROL
Időperspektívák: CROSS_SECTIONAL

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz
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

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
3. Characterize the microbiome in the oral cavity of patients with genetic immune defects Időkeret: 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.	25 years
2. Characterize the immune response in the oral cavity of patients with genetic immune defects Időkeret: 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.	25 years
1. Clinical intraoral characterization (i.e., presence and severity of periodontitis). Időkeret: 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.	25 years

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
2. Establishment of normative values for immune mediators and microbial elements at the oral cavity Időkeret: 25 years	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	25 years
1. Assay development/validation for the study of tissue immunity and microbiome characterization Időkeret: 25 years	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	25 years

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

National Institute of Dental and Craniofacial Research (NIDCR)

Nyomozók

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

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Hasznos linkek

<p>NIH Clinical Center Detailed Web Page</p>

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2012. október 5.

Tanulmányi regisztráció dátumai

Először benyújtva

2012. március 30.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak