Periodontal Inflammation and Epigenetics in Obese Individuals
Association Between Epigenetic Changes, Periodontal Microbiota, And Periodontal Inflammation in Obese Individuals
The goal of this study is to investigate the long-term changes in host epigenetic modifications in obese individuals with periodontitis. The aims of the study are:
• To monitor longitudinal changes in host epigenetic modifiers following non-surgical periodontal therapy in periodontitis patients Study subjects would be categorized into two groups, non-obese with periodontitis, and obese with periodontitis. The study will primarily evaluate changes among these groups cross-sectionally, then longitudinally following non-surgical periodontal therapy (deep cleaning) to determine if any changes occur with treatment.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Periodontitis is an inflammatory disease process primarily caused by microorganisms, which affects the tooth-supporting structures and can eventually lead to tooth loss. Oral health is a reflection of general health. Accordingly, obesity can influence periodontitis and increase its severity. The study participants will be categorized into two groups as described above. Enrolled participants will be balanced for distribution of age, gender, ethnicity, and general health.
The objective of this pilot study is to investigate the cross-sectional and longitudinal changes in host epigenetic modifications in obese individuals with periodontitis. The investigators intend to examine these host epigenetic changes in obese and non-obese individuals with both periodontal health and periodontitis. The study will primarily evaluate longitudinal changes following non-surgical periodontal therapy (considered the gold standard for the initial treatment of periodontitis) to determine whether any modifications occur with treatment.
To control for other factors affecting periodontitis, the investigators plan to exclude diabetic participants, document oral hygiene habits, and monitor periodontal microorganisms and inflammatory mediators in the groups for further associations. In summary, the study will identify important epigenetic signatures in obese participants with periodontal disease compared to those with periodontal health as a potential causal factor linking the two conditions.
The investigators hypothesize that epigenetic programs in obese individuals will influence the severity of periodontal disease by altering inflammatory pathways and the microbial environment.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Vinayak M Joshi, PhD, MS
- 전화번호: 15049418280
- 이메일: vjosh1@lsuhsc.edu
연구 연락처 백업
- 이름: Jeanne St.Germain, RDH, B.S.
- 전화번호: 504-941-8276
- 이메일: jstge1@lsuhsc.edu
연구 장소
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Louisiana
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New Orleans, Louisiana, 미국, 70119
- LSU Health Science Centre, School of Dentistry
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연락하다:
- Vinayak M Joshi, PhD, MS
- 전화번호: 15049418280
- 이메일: vjosh1@lsuhsc.edu
-
연락하다:
- Jeanne St.Germain, RDH, B.S.
- 전화번호: 504-941-8276
- 이메일: jstge1@lsuhsc.edu
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged ≥18 years,
- No history of periodontal therapy in the last 6 months,
- No use of tobacco,
- No history of pregnancy lactation or contraceptive medication.
- Need to have a minimum of 20 teeth.
Exclusion Criteria:
- Had antimicrobial/antiviral therapy in the previous 3 months,
- History of uncontrolled diabetes,
- History of rheumatoid arthritis,
- History of osteoporosis,
- History of oral cancer,
- Currently taking hormonal contraception,
- If pregnant or lactating currently or prior 6 months,
- Subjects on current weight loss drugs
- If planning weight reduction surgery during the time of the study
- Any other condition, disease or therapy with documented influence on oral inflammation and/or oral microbial environment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: non-obese with periodontitis
Non-surgical periodontal therapy will be administered
|
Non-surgical periodontal therapy (Deep cleaning-SRP): The deep cleaning by a scaling and root planing (SRP) procedure, is the standard initial treatment for all individuals diagnosed with periodontitis (periodontal disease).
At the initial treatment planning appointment, each subject will receive intra-oral and extra-oral examination along with full mouth examination of the periodontal status, followed by diagnosis and treatment planning.
The subject will then be scheduled for a deep cleaning procedure.
The Deep cleaning procedure are carried out using hand instruments and ultrasonic instruments.
다른 이름들:
|
|
활성 비교기: obese with periodontitis
Non-surgical periodontal therapy will be administered
|
Non-surgical periodontal therapy (Deep cleaning-SRP): The deep cleaning by a scaling and root planing (SRP) procedure, is the standard initial treatment for all individuals diagnosed with periodontitis (periodontal disease).
At the initial treatment planning appointment, each subject will receive intra-oral and extra-oral examination along with full mouth examination of the periodontal status, followed by diagnosis and treatment planning.
The subject will then be scheduled for a deep cleaning procedure.
The Deep cleaning procedure are carried out using hand instruments and ultrasonic instruments.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Host-specific epigenetic signatures
기간: Baseline/Day 1
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Gingival crevicular fluid and saliva will be analyzed to study epigenetic signatures
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Baseline/Day 1
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Inflammatory cytokine profiles
기간: Baseline/Day 1
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Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine profiles.
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Baseline/Day 1
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Periodontal microbial composition
기간: Baseline/Day 1
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Subgingival plague will be analyzed to study periodontal microbial composition
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Baseline/Day 1
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Host epigenetic modifiers pre- and post-therapy
기간: Baseline/Day 1, Day 30, Day 90
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Gingival crevicular fluid and saliva will be analyzed to study epigenetic changes.
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Baseline/Day 1, Day 30, Day 90
|
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Inflammatory cytokine changes pre- and post-therapy
기간: Baseline/Day 1, Day 30, Day 90
|
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine changes.
|
Baseline/Day 1, Day 30, Day 90
|
|
Periodontal microbial changes pre- and post-therapy
기간: Baseline/Day 1, Day 30, Day 90
|
Subgingival plague will be analyzed to study periodontal microbial changes.
|
Baseline/Day 1, Day 30, Day 90
|
공동 작업자 및 조사자
스폰서
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 8320 (New York State Psychiatric Institute Institutional Review Board)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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