- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Osman Babayiğit
- Telefonní číslo: +90 506 320 84 74
- E-mail: obabayigit@erbakan.edu.tr
Studijní místa
-
-
Konya
-
Konya, Konya, Turecko (Türkiye), 42090
- Nábor
- Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology
-
Kontakt:
- Osman Babayiğit
- Telefonní číslo: +90 506 320 84 74
- E-mail: obabayigit@erbakan.edu.tr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Periodontally Healthy Systemically Healthy Group
Periodontally healthy individuals without type 2 diabetes mellitus or other systemic diseases.
|
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.
Ostatní jména:
|
|
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.
Ostatní jména:
|
|
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.
Ostatní jména:
|
|
Periodontitis Type 2 Diabetes Group
Individuals diagnosed with both generalized Stage II or Stage III periodontitis and 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels
Časové okno: Baseline, before periodontal treatment
|
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.
|
Baseline, before periodontal treatment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NEU-DIS-OB-05
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Salivary Biomarker Analysis
-
Burcin CelikOndokuz Mayıs UniversityZatím nenabírámeChronická obstrukční plicní nemoc (CHOPN)
-
Istituto per la Ricerca e l'Innovazione BiomedicaNábor
-
University of VirginiaNeznámý
-
IRCCS Eugenio MedeaDokončenoPoruchou autistického spektra | Včasná intervenceItálie
-
Fundacion Clinic per a la Recerca BiomédicaHospital Clinic of BarcelonaNáborNevi a melanomy | Melanom (rakovina kůže)Španělsko
-
Rio de Janeiro State UniversityCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... a další spolupracovníciDokončenoKardiovaskulární choroby | Nedostatek vitaminu D | Stavy související s menopauzouBrazílie
-
University Hospital, ToulouseNábor
-
Chang Gung Memorial HospitalNeznámýNosní onemocněníTchaj-wan
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)DokončenoRakovina děložního tělíska ve stádiu I | Rakovina děložního tělíska II | Rakovina děložního tělíska ve stádiu III | Rakovina děložního těla ve stádiu IV | Endometriální serózní adenokarcinomSpojené státy