Salivary Free Amino Acid Profiles in Periodontitis: Associations With Clinical Parameters and Dynamic Responses to Non Surgical Therapy (FAA-CP-SRP)
2026年6月19日 更新者：Zhang, Yuwei
A Cross-Sectional and Prospective Cohort Study of Salivary Free Amino Acid Profiles in Patients With Periodontal Health, Gingivitis and Periodontitis: Associations With Clinical Parameters and Dynamic Responses to Non-Surgical Periodontal Therapy
# Brief Summary (Word count: 198)
This combined observational and interventional study investigates salivary amino acid profiles and their connections to periodontal conditions, as well as how these substances change after standard non-surgical gum treatment. It recruits adults aged 20 to 50, including healthy volunteers, people with gingivitis and periodontitis. The study is approved by the institutional ethics committee with the ID WCHSIRB-D-2023-370. The main questions it aims to answer are:
Do salivary free amino acid levels differ across people with healthy gums, gingivitis and periodontitis? Are changes in salivary branched-chain amino acids related to improved gum health after treatment?
Researchers compare three groups in the observational part and track periodontitis patients to assess treatment effects. All participants go through eligibility screening, full periodontal checks and morning saliva collection. 45 participants complete only one baseline visit. Another 32 periodontitis patients receive standard therapy and return for re-examinations at 6 and 12 weeks. Saliva samples are tested for amino acid concentrations. Statistical analysis will explore the correlation between salivary markers and gum conditions. The results may aid clinical evaluation and management of periodontal diseases.
調査の概要
研究の種類
介入
入学 (実際)
77
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Sichuan
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Chengdu、Sichuan、中国、610041
- West China Hospital of Stomatology, Sichuan University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Age between 20 and 50 years old at the time of enrollment.
- Body mass index (BMI) between 18.5 and 24.0 kg/m².
- No special dietary habits (e.g., long-term vegetarian diet, extreme dieting) and no food allergies.
- Body weight fluctuation less than 3 kg in the past 6 months before enrollment.
- At least 20 natural teeth remaining in the oral cavity (excluding third molars).
- Able to understand and sign the written informed consent form voluntarily.
- Able to attend all scheduled follow-up visits as required.
- For participants in the interventional arm: diagnosed with periodontitis according to the 2018 International Classification of Periodontal and Peri-Implant Diseases and Conditions.
Exclusion Criteria:
- Systemic diseases such as diabetes mellitus, rheumatoid arthritis, or immunodeficiency disorders.
- Use of antibiotics, anti-inflammatory drugs, or antioxidant medications within 3 months before enrollment.
- Received any form of periodontal treatment (e.g., scaling, root planing, periodontal surgery) within 6 months before enrollment.
- Long-term use of medications known to affect gingival health, including calcium channel blockers, phenytoin, cyclosporine, or hormone replacement therapy drugs.
- History of smoking (current or former smokers) or use of tobacco products within the past 5 years.
- Pregnant or lactating women.
- Presence of severe oral mucosal diseases or active dental caries requiring immediate treatment.
- Participation in other interventional clinical trials within the past 30 days.
- Mental or cognitive disorders that may affect the ability to comply with study procedures.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：Non-Surgical Periodontal Therapy Group
Participants in this experimental arm receive standardized non-surgical periodontal therapy.
The treatment includes personalized oral hygiene instruction and quadrant-wise scaling and root planing, performed once weekly following the European Federation of Periodontology (EFP) clinical practice guidelines.
Post-treatment follow-up assessments, including full-mouth periodontal examinations and unstimulated saliva collection, are scheduled at 6 weeks and 12 weeks after therapy completion to evaluate clinical outcomes and salivary amino acids changes.
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Standardized non-surgical periodontal therapy, including personalized oral hygiene instruction and quadrant-wise scaling and root planing, is provided once weekly following the European Federation of Periodontology (EFP) clinical practice guidelines.
The goal is to remove supra- and subgingival plaque and calculus to reduce periodontal inflammation.
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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 |
|---|---|---|
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Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 12 Weeks Post-Treatment
時間枠：Baseline (pre-treatment) and 12 weeks post-treatment
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Salivary concentrations of branched-chain amino acids (BCAAs: leucine, isoleucine, valine) will be measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS) at three time points: baseline (pre-treatment), 6 weeks post-treatment, and 12 weeks post-treatment.
The primary outcome is the mean change in BCAA levels from baseline to the 12-week follow-up, reflecting the long-term metabolic response to non-surgical periodontal therapy.
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Baseline (pre-treatment) and 12 weeks post-treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Mean Probing Depth (PD) from Baseline to 12 Weeks Post-Treatment
時間枠：Baseline (pre-treatment) and 12 weeks post-treatment
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Probing depth (PD) will be measured at six sites per tooth using a calibrated UNC-15 periodontal probe at baseline and 12 weeks post-treatment.
The mean change in PD from baseline to 12 weeks will be calculated to assess the improvement in periodontal pocket depth after therapy.
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Baseline (pre-treatment) and 12 weeks post-treatment
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Change in Mean Clinical Attachment Level (CAL) from Baseline to 12 Weeks Post-Treatment
時間枠：Baseline (pre-treatment) and 12 weeks post-treatment
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Clinical attachment level (CAL) will be measured at six sites per tooth using a calibrated periodontal probe at baseline and 12 weeks post-treatment.
The mean change in CAL from baseline to 12 weeks will be evaluated to reflect improvements in periodontal attachment support.
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Baseline (pre-treatment) and 12 weeks post-treatment
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Change in Bleeding on Probing Percentage (BOP%) from Baseline to 12 Weeks Post-Treatment
時間枠：Baseline (pre-treatment) and 12 weeks post-treatment
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Bleeding on probing (BOP) will be recorded as present or absent at six sites per tooth during periodontal examinations at baseline and 12 weeks post-treatment.
The percentage of bleeding sites (BOP%) will be calculated, and the change from baseline to 12 weeks will be analyzed to assess reductions in periodontal inflammation.
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Baseline (pre-treatment) and 12 weeks post-treatment
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Change in Mean Probing Depth (PD) from Baseline to 6 Weeks Post-Treatment
時間枠：Baseline (pre-treatment) and 6 weeks post-treatment
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Probing depth (PD) will be measured at six sites per tooth at baseline and 6 weeks post-treatment.
The mean change in PD from baseline to 6 weeks will be analyzed to evaluate the early clinical response to non-surgical periodontal therapy.
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Baseline (pre-treatment) and 6 weeks post-treatment
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年11月1日
一次修了 (実際)
2024年10月5日
研究の完了 (実際)
2024年10月5日
試験登録日
最初に提出
2026年6月19日
QC基準を満たした最初の提出物
2026年6月19日
最初の投稿 (実際)
2026年6月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月25日
QC基準を満たした最後の更新が送信されました
2026年6月19日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- WCHSIRB-D-2023-370
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?
いいえ
IPD プランの説明
Individual participant data (IPD) will not be shared with other researchers due to restrictions from the institutional review board (IRB) and hospital data management policies, which are designed to protect patient privacy and confidentiality.
The aggregated results of this study will be published in peer-reviewed journals.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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