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Salivary Free Amino Acid Profiles in Periodontitis: Associations With Clinical Parameters and Dynamic Responses to Non Surgical Therapy (FAA-CP-SRP)

19. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

77

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Stomatology, Sichuan University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: Non-surgical periodontal therapy
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 12 Weeks Post-Treatment
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Mean Probing Depth (PD) from Baseline to 12 Weeks Post-Treatment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Zhang, Yuwei

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2023

Primärer Abschluss (Tatsächlich)

5. Oktober 2024

Studienabschluss (Tatsächlich)

5. Oktober 2024

Studienanmeldedaten

Zuerst eingereicht

19. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Juni 2026

Zuerst gepostet (Tatsächlich)

25. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • WCHSIRB-D-2023-370

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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Bedingungen

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