Peri-Implant HealthAAsNCT07187323
Free Amino-acid Composition of Peri-implant and Periodontal Conditions
An observational study of Peri-Implant Health and Peri Implant Mucositis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Health, Peri Implant Mucositis, Peri Implantitis
- What is being tested?
- Saliva sampling and Amino Acid Analysis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2024to 20 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, School of Dentistry
Istanbul, Istanbul, 34083
About this study
Official title: Free Amino-acid Composition of Saliva in Patients With Different 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
Read the 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.
- Being tested
- Saliva sampling, Amino Acid Analysis
- Keywords
- peri-implantitis, amino acids, saliva
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva samplingOther
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 AnalysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Amino Acid Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months
Secondary outcomes (1)
saliva analyses for selected molecules
Quantitative analysis of amino acids in saliva was carried out using liquid chromatography-tandem mass spectrometry.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start2 Aug 2024
- Primary completion5 May 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implant HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lokman Hekim University, Ankara University, Ankara Medipol University
- Responsible party
- Principal investigator, Nur Balci, DDs, PhD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187323
- Sponsor's protocol ID
- 645
- Other IDs
- Istanbul Medipol University
- Acronym
- AAs
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Amino-acid Composition of Saliva in Patients With Different Peri-implant and Periodontal Conditions
- ClinicalTrials.gov ID
- NCT07187323
- Acronym / sponsor ID
- AAs / 645
- Keywords
- peri-implantitis, amino acids, saliva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Lokman Hekim University, Ankara University, Ankara Medipol University
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saliva collection | – | Other: Saliva samplingSaliva 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. |
| Amino Acid Analysis | – | Other: Amino Acid AnalysisQuantitative 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). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva 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 . | Other | Saliva collection |
| Amino 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. | Other | Amino Acid Analysis |
Primary outcome
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
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
1 secondary outcome
saliva analyses for selected molecules
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implant Health and Peri Implant Mucositis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket probing depth (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.