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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
研究概览
简要总结
# 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究者
Zhang, Yuwei
PhD Candidate, Department of Periodontology
West China College of Stomatology