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

NCT07187323 | Completed

• 2 other identifiers: 645Istanbul Medipol University
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Peri-Implant Health; Peri Implant Mucositis; Peri Implantitis

Keywords

peri-implantitis; amino acids; saliva

Outcome Measures

Primary Outcomes (2)

• Pocket probing depth

  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

  3 months

• Bleeding on probing

  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

  4 months

Secondary Outcomes (1)

• saliva analyses for selected molecules

  4 months

Study Arms (2)

Saliva collection

Saliva and serum sampling Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff from each participant. Saliva and serum were then stored at -80 °C until analysis.

Other: Saliva sampling

Amino Acid Analysis

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 (Thermo Scientific, Schaumburg, IL, USA).

Other: Amino Acid Analysis

Interventions

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 .

Saliva collection

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.

Amino Acid Analysis

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who has healthy implants, the peri implant mucositis patients, peri-implantitis patients, periodontally healthy volunteers, gingivitis and stage 3 grade b patients were enrolled in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Lokman Hekim University: collaborator
• Ankara University: collaborator
• Ankara Medipol University: collaborator

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Sequence Analysis, Protein

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: August 2, 2024
• Primary Completion: May 5, 2025
• Study Completion: August 20, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)