Salivary Free Amino Acid Profiles in Periodontitis: Associations With Clinical Parameters and Dynamic Responses to Non Surgical Therapy (FAA-CP-SRP)
2026년 6월 19일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
77
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Sichuan
-
Chengdu, Sichuan, 중국, 610041
- West China Hospital of Stomatology, Sichuan University
-
-
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
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 12 Weeks Post-Treatment
기간: Baseline (pre-treatment) and 12 weeks post-treatment
|
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.
|
Baseline (pre-treatment) and 12 weeks post-treatment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Mean Probing Depth (PD) from Baseline to 12 Weeks Post-Treatment
기간: Baseline (pre-treatment) and 12 weeks post-treatment
|
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.
|
Baseline (pre-treatment) and 12 weeks post-treatment
|
|
Change in Mean Clinical Attachment Level (CAL) from Baseline to 12 Weeks Post-Treatment
기간: Baseline (pre-treatment) and 12 weeks post-treatment
|
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.
|
Baseline (pre-treatment) and 12 weeks post-treatment
|
|
Change in Bleeding on Probing Percentage (BOP%) from Baseline to 12 Weeks Post-Treatment
기간: Baseline (pre-treatment) and 12 weeks post-treatment
|
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.
|
Baseline (pre-treatment) and 12 weeks post-treatment
|
|
Change in Mean Probing Depth (PD) from Baseline to 6 Weeks Post-Treatment
기간: Baseline (pre-treatment) and 6 weeks post-treatment
|
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.
|
Baseline (pre-treatment) and 6 weeks post-treatment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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)
2023년 11월 1일
기본 완료 (실제)
2024년 10월 5일
연구 완료 (실제)
2024년 10월 5일
연구 등록 날짜
최초 제출
2026년 6월 19일
QC 기준을 충족하는 최초 제출
2026년 6월 19일
처음 게시됨 (실제)
2026년 6월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 19일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- WCHSIRB-D-2023-370
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
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. .