Clinical Trials Directory

Trials / Completed

CompletedNCT07187323

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
120 (actual)
Sponsor
Istanbul Medipol University Hospital · Academic / Other
Sex
All
Age
20 Years – 65 Years
Healthy volunteers
Accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERSaliva samplingUnstimulated, 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 .
OTHERAmino Acid AnalysisSaliva 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.

Timeline

Start date
2024-08-02
Primary completion
2025-05-05
Completion
2025-08-20
First posted
2025-09-23
Last updated
2025-09-23

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07187323. Inclusion in this directory is not an endorsement.