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Completed

NCT Number: NCT07187323

Free Amino-acid Composition of Peri-implant and Periodontal Conditions

Peri-implant diseases, encompassing peri-implant mucositis and peri-implantitis, are biologically driven inflammatory conditions that threaten the long-term success of dental implants. The microbial signatures and their metabolic products have prompted growing interest in salivary biomarkers, particularly amino acids (AAs), which may reflect both microbial activity and host response.However, despite increasing evidence of periodontal disease, the role of salivary AAs in peri-implant conditions remains underexplored.The aim of this study is to comprehensively evaluate and compare the salivary free amino acid profiles among individuals with peri-implantitis, peri-implant mucositis, and healthy peri-implant mucosa, as well as those with periodontitis, gingivitis, and a healthy periodontium, and seeks to investigate whether distinct salivary amino acid signatures are linked to different stages and types of peri-implant and periodontal inflammation, and to evaluate their potential as non-invasive biomarkers for disease differentiation, activity, and severity

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Key information

Conditions

Peri-Implant Health Mouth Diseases Peri Implant Mucositis Peri Implantitis Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University, School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

About this study

The study included one-hundred and thirty-two patients who applied to the Department of Periodontology at Istanbul Medipol University, Faculty of Dentistry. Four of the one-hundred and thirty-two patients declined to participate in the trial. Two patients were eliminated because they had recently taken antibiotics, six patients were discarded because they had recently received periodontal therapy, and six patients were excluded because they had systemic diseases, resulting in a final sample size of one-hundred and twenty patients .Quantitative analysis of amino acids in saliva was carried out using liquid chromatography-tandem mass spectrometry (LC-MS/MS) with a Thermo Scientific TSQ Quantum Access MAX system.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • be between 18 and 65 years of age
  • have a minimum of 20 natural teeth, excluding third molars (for non-implant-treated groups)
  • be edentulous patients treated with implants loaded at least 1 year prior (for implant-treated groups)
  • be in a systemically healthy condition.

Exclusion criteria

  • current tobacco use
  • chronic use of any systemic medication
  • use of antibiotics, anti-inflammatory drugs (including corticosteroids and NSAIDs), immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within the 3 months prior to the study
  • receipt of periodontal therapy within the past 6 months
  • pregnancy or breastfeeding
  • presence of orthodontic appliances a DMFT index (Decayed, Missing, and Filled Teeth per tooth) greater than 2

Treatment and study plan

Saliva sampling

Other

Unstimulated, whole saliva was collected from all participants across the six study groups following a detailed explanation of the procedure. Initially, individuals were asked to rinse their mouths with filtered water and remain seated in a relaxed position for five minutes. Then, they were instructed to passively drool into a sterile collection tube over a 10-minute period.31 The collected saliva samples were then centrifuged at 3000 ×g for 10 minutes to remove debris and prepare them for storage at -80°C .

Amino Acid Analysis

Other

Saliva samples were deproteinized by mixing with 6% sulfosalicylic acid in a 1:1 ratio, followed by incubation at room temperature for 5 minutes. The mixtures were then centrifuged at 15,000 rpm for 5 minutes. A 10 µL aliquot of the resulting supernatant was diluted with 800 µL of 2 mM tridecafluoroheptanoic acid containing 0.375 M glucosaminic acid and internal standards. The prepared solutions were transferred into autosampler vials for analysis. Calibration standards were generated by combining known concentrations of amino acid standards.

Primary outcomes

  1. Pocket probing depth

    Time frame: 3 months

    Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe

  2. Bleeding on probing

    Time frame: 4 months

    Bleeding on probing referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth

Secondary outcomes

  1. saliva analyses for selected molecules

    Time frame: 4 months

    Quantitative analysis of amino acids in saliva was carried out using liquid chromatography-tandem mass spectrometry.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Collaborators

  • Ankara Medipol University
  • Ankara University
  • Lokman Hekim University

Registry information

Official study title

Free Amino-acid Composition of Saliva in Patients With Different Peri-implant and Periodontal Conditions

Acronym: AAs

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

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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