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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

77

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 12 Weeks Post-Treatment
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Mean Probing Depth (PD) from Baseline to 12 Weeks Post-Treatment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zhang, Yuwei

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2023

Primaire voltooiing (Werkelijk)

5 oktober 2024

Studie voltooiing (Werkelijk)

5 oktober 2024

Studieregistratiedata

Eerst ingediend

19 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 juni 2026

Eerst geplaatst (Werkelijk)

25 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

19 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • WCHSIRB-D-2023-370

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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