CompletedNot Applicable

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

China77 participantsStarted 2023-11-01

Plain-language 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.

Who can participate

Age range

20 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 othe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07669233

SponsorZhang, Yuwei

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-05

View on ClinicalTrials.gov More Periodontitis trials