Niveaux de l'Apéline salivaire, de la Chémérine, de la Ghréline et de la Lipocaline 2 chez les patients diabétiques atteints de parodontite
Cette étude observationnelle vise à mesurer et comparer les niveaux salivaires d'apeline, de chémérine, de ghréline et de lipocaline-2 chez les individus atteints et non atteints de diabète de type 2, avant le traitement parodontal, afin de comprendre leur association avec le statut parodontal.
Test diagnostique Data
+ diagnosticTest Data
+ diagnosticTest Data
Données recueillies dès le début de l'étude - ProspectiveDiabète Mellitus+7
+ Maladies du système endocrinien
+ Maladies métaboliques
Cas témoins
Analyse de profils avec et sans la maladie pour comprendre ce qui pourrait l'avoir favorisée.Résumé
Date de début de l'étude : 1 juillet 2026
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.88 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cas témoins
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 80 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.4 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology
Konya, Turkey (Türkiye)Ouvrir Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology dans Google Maps