Peri-ImplantitisNCT07864233
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
An observational study of Peri-Implantitis, run by Necmettin Erbakan University.
Trial summary
Peri-implantitis is an inflammatory condition affecting the tissues surrounding dental implants and may lead to supporting bone loss. Current diagnosis is mainly based on clinical and radiographic findings. However, these methods may not fully reflect the biological changes occurring around implants. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- ATR-FTIR and Raman Spectroscopic Analysis of Peri-Implant Crevicular Fluid
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 15 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older presenting to the Periodontology Clinic of Necmettin Erbakan University Faculty of Dentistry who have at least two dental implants, including at least one peri-implant healthy implant and at least one implant diagnosed with peri-implantitis. One healthy implant and one peri-implantitis implant from each eligible participant will be evaluated in a within-participant split-mouth design.
Who may be able to join
- Age 18 years or older Presence of dental implants that have been in function for at least 1 year Presence of at least one peri-implant healthy implant and at least one implant with peri-implantitis in the same participant Ability and willingness to provide written informed consent
Who cannot join
- Pregnancy or breastfeeding Use of systemic antibiotics within the previous 3 months History of periodontal or peri-implant treatment within the previous 6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Peri-Implant Crevicular Fluid in Peri-Implant Health and Peri-Implantitis Using ATR-FTIR and Raman Spectroscopy: A Split-Mouth Clinical Study
Peri-implantitis is an inflammatory condition affecting the tissues surrounding dental implants and may lead to supporting bone loss. Current diagnosis is mainly based on clinical and radiographic findings. However, these methods may not fully reflect the biological changes occurring around implants.
The purpose of this observational study is to evaluate whether peri-implant crevicular fluid (PICF), a biological fluid collected from around dental implants, shows different molecular characteristics in peri-implant health and peri-implantitis. Adults who have at least one healthy dental implant and one implant with peri-implantitis will be included.
Read more
For each participant, PICF samples will be collected from one healthy implant and one peri-implantitis implant. The samples will be analyzed using attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy and Raman spectroscopy. These techniques provide molecular information about biological samples without requiring additional invasive procedures.
The study will compare the spectral profiles obtained from healthy and peri-implantitis sites and evaluate whether these profiles can distinguish peri-implant health from peri-implantitis. Relationships between spectral findings and clinical factors, including probing depth, bleeding on probing, suppuration, radiographic bone loss, smoking status, and diabetes status, will also be explored.
Read the detailed description
This is an observational, analytical, cross-sectional clinical study with a within-participant split-mouth design. The study aims to characterize peri-implant crevicular fluid (PICF) obtained from peri-implant healthy and peri-implantitis sites using attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy and Raman spectroscopy.
Adults aged 18 years or older who have at least two dental implants, including at least one implant meeting the criteria for peri-implant health and at least one implant diagnosed with peri-implantitis, will be eligible for participation. Dental implants must have been in function for at least one year. Peri-implantitis will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
For each participant, one peri-implant healthy implant and one peri-implantitis implant will be selected for evaluation. If more than one peri-implantitis implant is eligible, the implant with the greatest probing depth and radiographic bone loss will be selected. If clinical findings are similar, random selection will be used. When more than one healthy implant is available, preference will be given to an implant located in the same jaw as the peri-implantitis implant, with random selection used when necessary.
Clinical peri-implant parameters will include plaque index, bleeding on probing, probing depth, suppuration, keratinized mucosal width, and radiographic bone loss. Implant-related characteristics, including time in function and prosthetic retention type, will also be recorded. Participant-level information including age, sex, systemic disease history, smoking status, diabetes status, and body mass index will be collected.
PICF samples will be obtained after isolation of the sampling site and removal of supragingival plaque. Sterile PerioPaper strips will be inserted into the peri-implant sulcus for 30 seconds. Samples contaminated with blood or saliva will be excluded. Collected samples will be stored at -80°C until spectroscopic analysis.
ATR-FTIR spectroscopy will be used to evaluate molecular spectral features associated with proteins, lipids, carbohydrates, nucleic acids, and other biochemical components. Raman spectroscopy will provide complementary molecular information based on light-scattering characteristics. Technical replicate measurements will be performed to improve the reliability and representativeness of the spectral data.
Spectral data will undergo exploratory and classification analyses. Principal component analysis (PCA) will be used for exploratory evaluation, and classification approaches may include partial least squares discriminant analysis (PLS-DA), support vector machine (SVM), and Random Forest. Classification performance will be evaluated using receiver operating characteristic area under the curve (ROC-AUC), sensitivity, specificity, accuracy, and confusion matrices. Validation procedures will be performed at the participant level to reduce the risk of data leakage.
The primary objective is to determine the ability of ATR-FTIR and Raman spectral profiles of PICF to distinguish peri-implant health from peri-implantitis within the same participant. Secondary analyses will evaluate associations between spectral findings and clinical or systemic parameters, compare the diagnostic performance of ATR-FTIR and Raman spectroscopy, and assess the performance of machine-learning-based classification models. Smoking and diabetes status will also be evaluated as exploratory secondary variables when the available sample size permits.
- Conditions
- Peri-Implantitis
- Being tested
- ATR-FTIR and Raman Spectroscopic Analysis of Peri-Implant Crevicular Fluid
- Keywords
- Peri-Implant Crevicular Fluid, PICF, Peri-Implant Health, ATR-FTIR Spectroscopy, Raman Spectroscopy
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATR-FTIR and Raman Spectroscopic Analysis of Peri-Implant Crevicular FluidOther
Peri-implant crevicular fluid (PICF) samples will be collected from one peri-implant healthy implant and one peri-implantitis implant in each participant using sterile PerioPaper strips. The samples will be analyzed using ATR-FTIR and Raman spectroscopy to characterize molecular spectral profiles and compare peri-implant health with peri-implantitis.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Paired Peri-Implant Sites | Participants with at least one peri-implant healthy implant and at least one implant diagnosed with peri-implantitis. One healthy implant and one peri-implantitis implant from each participant will be evaluated and compared using a within-participant split-mouth design. Receives: Other: ATR-FTIR and Raman Spectroscopic Analysis of Peri-Implant Crevicular Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of Raman Spectral Profiles
The ability of peri-implant crevicular fluid (PICF) spectral profiles obtained by Raman spectroscopy to discriminate between peri-implant health and peri-implantitis will be evaluated using receiver operating characteristic analysis. Diagnostic performance will be reported using the area under the receiver operating characteristic curve (AUC).
Measured: Baseline
Diagnostic Performance of ATR-FTIR Spectral Profiles
The ability of peri-implant crevicular fluid (PICF) spectral profiles obtained by ATR-FTIR spectroscopy to discriminate between peri-implant health and peri-implantitis will be evaluated using receiver operating characteristic analysis. Diagnostic performance will be reported using the area under the receiver operating characteristic curve (AUC).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Babayigit, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864233
- Sponsor's protocol ID
- NEU-DHF-PERIO-OB-07
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-Implant Crevicular Fluid in Peri-Implant Health and Peri-Implantitis Using ATR-FTIR and Raman Spectroscopy: A Split-Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT07864233
- Acronym / sponsor ID
- NEU-DHF-PERIO-OB-07
- Conditions
- Peri-Implantitis
- Keywords
- Peri-Implant Crevicular Fluid, PICF, Peri-Implant Health, ATR-FTIR Spectroscopy, Raman Spectroscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 7 Oct 2026 (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-implantitis is an inflammatory condition affecting the tissues surrounding dental implants and may lead to supporting bone loss. Current diagnosis is mainly based on clinical and radiographic findings. However, these methods may not fully reflect the biological changes occurring around implants.
The purpose of this observational study is to evaluate whether peri-implant crevicular fluid (PICF), a biological fluid collected from around dental implants, shows different molecular characteristics in peri-implant health and peri-implantitis. Adults who have at least one healthy dental implant and one implant with peri-implantitis will be included.
For each participant, PICF samples will be collected from one healthy implant and one peri-implantitis implant. The samples will be analyzed using attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy and Raman spectroscopy. These techniques provide molecular information about biological samples without requiring additional invasive procedures.
The study will compare the spectral profiles obtained from healthy and peri-implantitis sites and evaluate whether these profiles can distinguish peri-implant health from peri-implantitis. Relationships between spectral findings and clinical factors, including probing depth, bleeding on probing, suppuration, radiographic bone loss, smoking status, and diabetes status, will also be explored.
Detailed description
This is an observational, analytical, cross-sectional clinical study with a within-participant split-mouth design. The study aims to characterize peri-implant crevicular fluid (PICF) obtained from peri-implant healthy and peri-implantitis sites using attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy and Raman spectroscopy.
Adults aged 18 years or older who have at least two dental implants, including at least one implant meeting the criteria for peri-implant health and at least one implant diagnosed with peri-implantitis, will be eligible for participation. Dental implants must have been in function for at least one year. Peri-implantitis will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
For each participant, one peri-implant healthy implant and one peri-implantitis implant will be selected for evaluation. If more than one peri-implantitis implant is eligible, the implant with the greatest probing depth and radiographic bone loss will be selected. If clinical findings are similar, random selection will be used. When more than one healthy implant is available, preference will be given to an implant located in the same jaw as the peri-implantitis implant, with random selection used when necessary.
Clinical peri-implant parameters will include plaque index, bleeding on probing, probing depth, suppuration, keratinized mucosal width, and radiographic bone loss. Implant-related characteristics, including time in function and prosthetic retention type, will also be recorded. Participant-level information including age, sex, systemic disease history, smoking status, diabetes status, and body mass index will be collected.
PICF samples will be obtained after isolation of the sampling site and removal of supragingival plaque. Sterile PerioPaper strips will be inserted into the peri-implant sulcus for 30 seconds. Samples contaminated with blood or saliva will be excluded. Collected samples will be stored at -80°C until spectroscopic analysis.
ATR-FTIR spectroscopy will be used to evaluate molecular spectral features associated with proteins, lipids, carbohydrates, nucleic acids, and other biochemical components. Raman spectroscopy will provide complementary molecular information based on light-scattering characteristics. Technical replicate measurements will be performed to improve the reliability and representativeness of the spectral data.
Spectral data will undergo exploratory and classification analyses. Principal component analysis (PCA) will be used for exploratory evaluation, and classification approaches may include partial least squares discriminant analysis (PLS-DA), support vector machine (SVM), and Random Forest. Classification performance will be evaluated using receiver operating characteristic area under the curve (ROC-AUC), sensitivity, specificity, accuracy, and confusion matrices. Validation procedures will be performed at the participant level to reduce the risk of data leakage.
The primary objective is to determine the ability of ATR-FTIR and Raman spectral profiles of PICF to distinguish peri-implant health from peri-implantitis within the same participant. Secondary analyses will evaluate associations between spectral findings and clinical or systemic parameters, compare the diagnostic performance of ATR-FTIR and Raman spectroscopy, and assess the performance of machine-learning-based classification models. Smoking and diabetes status will also be evaluated as exploratory secondary variables when the available sample size permits.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Paired Peri-Implant Sites | – | Other: ATR-FTIR and Raman Spectroscopic Analysis of Peri-Implant Crevicular FluidParticipants with at least one peri-implant healthy implant and at least one implant diagnosed with peri-implantitis. One healthy implant and one peri-implantitis implant from each participant will be evaluated and compared using a within-participant split-mouth design. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older presenting to the Periodontology Clinic of Necmettin Erbakan University Faculty of Dentistry who have at least two dental implants, including at least one peri-implant healthy implant and at least one implant diagnosed with peri-implantitis. One healthy implant and one peri-implantitis implant from each eligible participant will be evaluated in a within-participant split-mouth design.
Key inclusion criteria (1 listed)
- Age 18 years or older Presence of dental implants that have been in function for at least 1 year Presence of at least one peri-implant healthy implant and at least one implant with peri-implantitis in the same participant Ability and willingness to provide written informed consent
Key exclusion criteria (1 listed)
- Pregnancy or breastfeeding Use of systemic antibiotics within the previous 3 months History of periodontal or peri-implant treatment within the previous 6 months
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 |
|---|---|---|
| ATR-FTIR and Raman Spectroscopic Analysis of Peri-Implant Crevicular FluidPeri-implant crevicular fluid (PICF) samples will be collected from one peri-implant healthy implant and one peri-implantitis implant in each participant using sterile PerioPaper strips. The samples will be analyzed using ATR-FTIR and Raman spectroscopy to characterize molecular spectral profiles and compare peri-implant health with peri-implantitis. | Other | Participants With Paired Peri-Implant Sites |
Primary outcome
Diagnostic Performance of Raman Spectral Profiles
Time frame: Baseline
The ability of peri-implant crevicular fluid (PICF) spectral profiles obtained by Raman spectroscopy to discriminate between peri-implant health and peri-implantitis will be evaluated using receiver operating characteristic analysis. Diagnostic performance will be reported using the area under the receiver operating characteristic curve (AUC).
Diagnostic Performance of ATR-FTIR Spectral Profiles
Time frame: Baseline
The ability of peri-implant crevicular fluid (PICF) spectral profiles obtained by ATR-FTIR spectroscopy to discriminate between peri-implant health and peri-implantitis will be evaluated using receiver operating characteristic analysis. Diagnostic performance will be reported using the area under the receiver operating characteristic curve (AUC).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Peri-Implantitis
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
Recruiting
Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants
Periimplant Diseases, Dental Implant Failure
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis, run by Necmettin Erbakan University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osman Babayiğit (+905063208474, obabayigit@erbakan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of Raman Spectral Profiles (time frame: Baseline). 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 7 Oct 2026.