Salivary Free Amino Acid Profiles in Periodontitis: Associations With Clinical Parameters and Dynamic Responses to Non Surgical Therapy (FAA-CP-SRP)
19 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
77
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- West China Hospital of Stomatology, Sichuan University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 12 Weeks Post-Treatment
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Mean Probing Depth (PD) from Baseline to 12 Weeks Post-Treatment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline (pre-treatment) and 6 weeks post-treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2023
Finalización primaria (Actual)
5 de octubre de 2024
Finalización del estudio (Actual)
5 de octubre de 2024
Fechas de registro del estudio
Enviado por primera vez
19 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WCHSIRB-D-2023-370
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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