[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659294":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":19,"studyPopulation":20,"armGroups":21,"interventions":27,"overallOfficials":16,"centralContacts":32,"locations":16,"responsibleParty":38,"collaborators":16,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":16,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":16,"studyType":55,"phases":16,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":65,"whyStopped":16,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":16},{"fullName":5,"class":6},"Necmettin Erbakan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"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).","Baseline",{"measure":14,"description":15,"timeFrame":12},"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).",null,{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":6,"timePerspective":18,"maskingInfo":16},"CROSS_SECTIONAL","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.\n\nAdults 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.\n\nFor 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.\n\nClinical 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.\n\nPICF 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.\n\nATR-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.\n\nSpectral 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.\n\nThe 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.","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.",[22],{"label":23,"type":16,"description":24,"interventionNames":25},"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.",[26],"Other: ATR-FTIR and Raman Spectroscopic Analysis of Peri-Implant Crevicular Fluid",[28],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":16},"ATR-FTIR and Raman Spectroscopic Analysis of Peri-Implant Crevicular Fluid","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.",[23],[33],{"name":34,"role":35,"phone":36,"phoneExt":16,"email":37},"Osman Babayiğit","CONTACT","+905063208474","obabayigit@erbakan.edu.tr",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Osman Babayigit","Associate Professor","100659294","atr-ftir-and-raman-spectroscopy-of-peri-implant-crevicular-fluid-in-peri-implantitis-100659294",false,"NCT07864233","ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis","Evaluation of Peri-Implant Crevicular Fluid in Peri-Implant Health and Peri-Implantitis Using ATR-FTIR and Raman Spectroscopy: A Split-Mouth Clinical Study","Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding Use of systemic antibiotics within the previous 3 months History of periodontal or peri-implant treatment within the previous 6 months","ALL","18 Years","100 Years",{"count":53,"type":54},100,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.\n\nFor 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.\n\nThe 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.",[58],"Peri-Implantitis",[60,61,62,63,64],"Peri-Implant Crevicular Fluid","PICF","Peri-Implant Health","ATR-FTIR Spectroscopy","Raman Spectroscopy","NOT_YET_RECRUITING","2026-10-04",{"date":68,"type":69},"2026-10-07","ACTUAL",{"date":71,"type":54},"2026-10-08",{"date":73,"type":54},"2027-04-15",{"name":5,"class":6}]