- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07703345
Salivary Apelin, Chemerin, Ghrelin, and Lipocalin-2 Levels in Diabetic Patients With Periodontitis
Evaluation of Salivary Apelin, Chemerin, Ghrelin and Lipocalin 2 Levels in Diabetic Patients With Periodontitis
This observational cross-sectional study will evaluate salivary apelin, chemerin, ghrelin, and lipocalin-2 levels in individuals with different periodontal and systemic conditions. Participants will be divided into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus.
Clinical periodontal measurements and unstimulated saliva samples will be obtained before periodontal treatment. Salivary biomarker levels will be measured using enzyme-linked immunosorbent assay kits. The study aims to determine whether salivary apelin, chemerin, ghrelin, and lipocalin-2 levels are associated with periodontitis, type 2 diabetes mellitus, and periodontal clinical parameters.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This observational cross-sectional study will be conducted at the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University. The study will include individuals who apply to the periodontology clinic for various reasons, meet the eligibility criteria, and agree to participate by signing the informed consent form.
The study population will consist of 88 individuals aged 18-80 years. Participants will be allocated into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus: periodontally healthy and systemically healthy individuals, periodontally healthy individuals with type 2 diabetes mellitus, systemically healthy individuals with periodontitis, and individuals with both periodontitis and type 2 diabetes mellitus. Each group will include 22 participants.
Periodontal status will be determined by a calibrated specialist clinician based on clinical and radiographic examinations according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions. Participants in the periodontitis groups will be required to meet the criteria for generalized Stage II or Stage III periodontitis. Periodontal clinical parameters, including probing depth, clinical attachment loss, bleeding on probing, gingival index, plaque index, gingival recession, tooth mobility, furcation involvement, and keratinized gingival width, will be recorded from six sites per tooth. Sociodemographic data, oral hygiene habits, and body mass index will also be recorded.
Unstimulated saliva samples will be collected before periodontal probing and before periodontal treatment in order to prevent possible contamination of saliva by bleeding during clinical measurements. Participants will be instructed not to brush their teeth and to avoid food, chewing gum, cosmetic products such as lipstick, and medications that may affect salivary measurements for at least one hour before sample collection. Saliva samples will be collected between 8:00 AM and 10:00 AM. After rinsing the mouth with water, saliva will be collected into plastic tubes using a glass funnel within five minutes. The samples will then be centrifuged at 1000 rpm for 10 minutes to remove cellular debris and plaque. The supernatant will be transferred into polypropylene Eppendorf tubes without disturbing the pellet and stored at -20°C until analysis.
On the day of analysis, samples will be thawed at +4°C. Salivary chemerin, ghrelin, apelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions.
The primary objective of the study is to compare salivary apelin, chemerin, ghrelin, and lipocalin-2 levels among individuals with different periodontal and systemic conditions. Secondary objectives include evaluating the relationships between salivary biomarker levels and clinical periodontal parameters and assessing the diagnostic performance of these biomarkers in distinguishing periodontitis from periodontal health.
Statistical analysis will be performed using IBM SPSS Statistics software. Continuous data will be expressed as mean and standard deviation. The normality of data distribution will be assessed using the Kolmogorov-Smirnov test. Between-group comparisons will be performed using appropriate parametric or non-parametric tests according to data distribution. Correlations between clinical and biochemical parameters will be evaluated. Receiver operating characteristic curve analysis will be used to assess the sensitivity and specificity of salivary biomarkers for distinguishing periodontitis from periodontal health. A p-value of less than 0.05 will be considered statistically significant.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Osman Babayiğit
- Numero di telefono: +90 506 320 84 74
- Email: obabayigit@erbakan.edu.tr
Luoghi di studio
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Konya
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Konya, Konya, Turchia (Türkiye), 42090
- Reclutamento
- Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology
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Contatto:
- Osman Babayiğit
- Numero di telefono: +90 506 320 84 74
- Email: obabayigit@erbakan.edu.tr
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Individuals aged 18 to 80 years. Individuals who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University.
Individuals who agree to participate in the study and sign the informed consent form.
Presence of at least 20 teeth. For the periodontally healthy groups: diagnosis of periodontal health based on routine clinical and radiographic examination.
For the periodontitis groups: diagnosis of generalized Stage II or Stage III periodontitis based on routine clinical and radiographic examination according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.
For the type 2 diabetes mellitus groups: diagnosis of type 2 diabetes mellitus. For the systemically healthy groups: absence of systemic diseases, including type 2 diabetes mellitus.
Exclusion Criteria:
- Periodontal treatment, including scaling and root surface debridement, within the last 6 months.
Antibiotic use within the last 6 months. Pregnancy or lactation. Presence of autoimmune diseases such as rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behçet disease, or psoriasis.
Presence of systemic diseases other than type 2 diabetes mellitus in the diabetes groups.
Presence of systemic diseases such as nephrotic syndrome, chronic renal disease, or cardiovascular disease.
Smoking 10 or more cigarettes per day.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Periodontally Healthy Systemically Healthy Group
Periodontally healthy individuals without type 2 diabetes mellitus or other systemic diseases.
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Unstimulated saliva samples will be collected from participants before periodontal treatment and before periodontal probing.
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions.
This procedure is used for biomarker assessment only and does not involve any therapeutic intervention.
Altri nomi:
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Periodontally Healthy Type 2 Diabetes Group
Periodontally healthy individuals diagnosed with type 2 diabetes mellitus.
|
Unstimulated saliva samples will be collected from participants before periodontal treatment and before periodontal probing.
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions.
This procedure is used for biomarker assessment only and does not involve any therapeutic intervention.
Altri nomi:
|
|
Periodontitis Systemically Healthy Group
Systemically healthy individuals diagnosed with generalized Stage II or Stage III periodontitis according to the 2017 World Workshop Classification.
|
Unstimulated saliva samples will be collected from participants before periodontal treatment and before periodontal probing.
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions.
This procedure is used for biomarker assessment only and does not involve any therapeutic intervention.
Altri nomi:
|
|
Periodontitis Type 2 Diabetes Group
Individuals diagnosed with both generalized Stage II or Stage III periodontitis and type 2 diabetes mellitus.
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Unstimulated saliva samples will be collected from participants before periodontal treatment and before periodontal probing.
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions.
This procedure is used for biomarker assessment only and does not involve any therapeutic intervention.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels
Lasso di tempo: Baseline, before periodontal treatment
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Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured in unstimulated saliva samples collected before periodontal treatment.
Biomarker levels will be analyzed using enzyme-linked immunosorbent assay kits and compared among the four study groups according to periodontal status and the presence or absence of type 2 diabetes mellitus.
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Baseline, before periodontal treatment
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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NEU-DIS-OB-05
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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