Salivary Free Amino Acid Profiles in Periodontitis: Associations With Clinical Parameters and Dynamic Responses to Non Surgical Therapy (FAA-CP-SRP)
19 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
77
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital of Stomatology, Sichuan University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 12 Weeks Post-Treatment
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Mean Probing Depth (PD) from Baseline to 12 Weeks Post-Treatment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de novembro de 2023
Conclusão Primária (Real)
5 de outubro de 2024
Conclusão do estudo (Real)
5 de outubro de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
19 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de junho de 2026
Primeira postagem (Real)
25 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- WCHSIRB-D-2023-370
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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