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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Vinayak M Joshi, PhD, MS
- 電話番号：15049418280
- メール：vjosh1@lsuhsc.edu
研究連絡先のバックアップ
- 名前：Jeanne St.Germain, RDH, B.S.
- 電話番号：504-941-8276
- メール：jstge1@lsuhsc.edu
研究場所
-
-
Louisiana
-
New Orleans、Louisiana、アメリカ、70119
- LSU Health Science Centre, School of Dentistry
-
コンタクト：
- Vinayak M Joshi, PhD, MS
- 電話番号：15049418280
- メール：vjosh1@lsuhsc.edu
-
コンタクト：
- Jeanne St.Germain, RDH, B.S.
- 電話番号：504-941-8276
- メール：jstge1@lsuhsc.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
他の名前：
|
|
アクティブコンパレータ：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Host-specific epigenetic signatures
時間枠：Baseline/Day 1
|
Gingival crevicular fluid and saliva will be analyzed to study epigenetic signatures
|
Baseline/Day 1
|
|
Inflammatory cytokine profiles
時間枠：Baseline/Day 1
|
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine profiles.
|
Baseline/Day 1
|
|
Periodontal microbial composition
時間枠：Baseline/Day 1
|
Subgingival plague will be analyzed to study periodontal microbial composition
|
Baseline/Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Host epigenetic modifiers pre- and post-therapy
時間枠：Baseline/Day 1, Day 30, Day 90
|
Gingival crevicular fluid and saliva will be analyzed to study epigenetic changes.
|
Baseline/Day 1, Day 30, Day 90
|
|
Inflammatory cytokine changes pre- and post-therapy
時間枠：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
時間枠：Baseline/Day 1, Day 30, Day 90
|
Subgingival plague will be analyzed to study periodontal microbial changes.
|
Baseline/Day 1, Day 30, Day 90
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 8320 (New York State Psychiatric Institute Institutional Review Board)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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