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

NCT07669233 | Completed

• 1 other identifier: WCHSIRB-D-2023-370
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

\# 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.

Conditions

Periodontitis; Gingivitis and Periodontal Diseases; Periodontal Debridement; Periodontal Attachment Loss; Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

• Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 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

Secondary Outcomes (4)

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

  Baseline (pre-treatment) and 12 weeks post-treatment

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

  Baseline (pre-treatment) and 12 weeks post-treatment

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

  Baseline (pre-treatment) and 12 weeks post-treatment

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

  Baseline (pre-treatment) and 6 weeks post-treatment

Study Arms (1)

Non-Surgical Periodontal Therapy Group

EXPERIMENTAL

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

Interventions

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.

Non-Surgical Periodontal Therapy Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhang, Yuwei: lead

Study Sites (1)

West China Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Periodontitis; Gingivitis; Periodontal Diseases; Periodontal Attachment Loss; Periodontal Pocket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate, Department of Periodontology

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: November 1, 2023
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)