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Completed

NCT Number: NCT07669233

Salivary Free Amino Acid Profiles in Periodontitis: Associations With Clinical Parameters and Dynamic Responses to Non Surgical 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.

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Key information

Conditions

Periodontitis Gingival Diseases Gingivitis Gingivitis and Periodontal Diseases Infections Mouth Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Debridement Periodontal Diseases Periodontal Pocket Stomatognathic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-surgical periodontal therapy

Procedure

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.

Primary outcomes

  1. Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 12 Weeks Post-Treatment

    Time frame: 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.

Secondary outcomes

  1. Change in Mean Probing Depth (PD) from Baseline to 12 Weeks Post-Treatment

    Time frame: 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.

  2. Change in Mean Clinical Attachment Level (CAL) from Baseline to 12 Weeks Post-Treatment

    Time frame: 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.

  3. Change in Bleeding on Probing Percentage (BOP%) from Baseline to 12 Weeks Post-Treatment

    Time frame: 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.

  4. Change in Mean Probing Depth (PD) from Baseline to 6 Weeks Post-Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhang, Yuwei

Other

Registry information

Official study title

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

Acronym: FAA-CP-SRP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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