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잇몸 질환(치주염)과 관련된 구강 박테리아 및 면역 체계 문제

2026년 10월 23일 업데이트: National Institute of Dental and Craniofacial Research (NIDCR)

면역 기능 장애 환자의 구강 미생물 및 면역학적 특성

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.

연구 개요

상태

모병

정황

상세 설명

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

  1. Investigate the degree, scope, etiology and natural history of oral manifestations in patients with genetic immune defects.
  2. Characterize the immune response in the oral cavity of patients with genetic immune defects.
  3. Characterize the microbiome in the oral cavity of patients with genetic immune defects.

Secondary Objectives

  1. Assay development/validation for the study of tissue immunity and microbiome characterization
  2. Establishment of normative values for immune mediators and microbial elements at the oral cavity

Study Population (s)

The study population will include:

  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)

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

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

Secondary Outcome Measures

  1. Assay development/validation for the study of tissue immunity and microbiome characterization
  2. 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.

연구 유형

관찰

등록 (추정된)

700

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Maryland
      • Bethesda, Maryland, 미국, 20892
        • 모병
        • National Institutes of Health Clinical Center
        • 연락하다:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • 전화번호: TTY dial 711 800-411-1222
          • 이메일: ccopr@nih.gov

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

7년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

  • 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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: CASE_CONTROL
  • 시간 관점: CROSS_SECTIONAL

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
3. Characterize the microbiome in the oral cavity of patients with genetic immune defects
기간: 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
기간: 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).
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
2. Establishment of normative values for immune mediators and microbial elements at the oral cavity
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Institute of Dental and Craniofacial Research (NIDCR)

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2012년 10월 5일

연구 등록 날짜

최초 제출

2012년 3월 30일

QC 기준을 충족하는 최초 제출

2012년 3월 30일

처음 게시됨 (추정된)

2012년 4월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 23일

마지막으로 확인됨

2026년 10월 9일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 120100
  • 12-D-0100

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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