The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases
The Effect of Vitamin D Levels and Supplementation on Anti-inflammatory Response in Periodontal Disease: a Randomized Controlled Clinical Trial
A review of the literature revealed that while there are studies investigating the relationship between vitamin D and periodontal disease, there are no studies investigating the anti-inflammatory effect of vitamin D on periodontal disease. Investigators hypothesized that the increased incidence of periodontal disease in individuals with vitamin D deficiency might be due not only to pro-inflammatory effects but also to impaired bone metabolism and a decrease in the anti- inflammatory mechanism. Investigators aimed to determine this by comparing serum and DOS levels of 1,25-dihydroxyvitamin D (1,25(OH)2D), 25-hydroxyvitamin D (25(OH)D3), Receptor activator nuclear kappa B ligand (RANKL), osteoprotegerin (OPG), Tumor Necrosis Factor Related Apoptosis induced Ligand (TRAIL), Developmental endothelial locus (Del)-1, Lipoxin, Resolvin, interleukin (IL)-10, and transforming growth factor-β (TGF-β).
The study will include 120 individuals who are systemically healthy based on clinical and radiographic examinations and diagnosed with Stage I-II periodontitis, Stage III-IV periodontitis, chronic gingivitis, and periodontally healthy. Periodontal clinical parameters (Probing pocket depth (PPD), Clinical attachment level (CAL), Bleeding on probing (BOP), Plaque index (PI), Gingival index (GI)) will be recorded three times: before treatment, and 6 and 12 weeks after treatment. Gingival crevicular fluid (GCF) and serum samples will be collected from participants at baseline and 12 weeks later for biochemical analysis.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hatice Yemenoglu
- Numéro de téléphone: +905052977517
- E-mail: htcymnglu@hotmail.com
Lieux d'étude
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Rize, Turquie (Türkiye), 53020
- Recrutement
- Recep Tayyip Erdogan University
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Contact:
- Hatice Yemenoglu
- Numéro de téléphone: +904642220000
- E-mail: htcymnglu@hotmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Study groups will be formed according to the 2017 Periodontal Disease Classification. Accordingly:
- Periodontally healthy; absence of bleeding on probing, erythema, edema, patient symptoms, attachment, and bone loss
- Gingivitis; patients with an average gingival index ≥0.5 according to Löe and Silness
- Stage I-II periodontitis; patients with CAL 1-2 or 3-4 mm and a maximum PPD ≤5 mm, showing radiographic horizontal bone loss up to the coronal third of the root (15%-33%), but without tooth loss due to periodontitis
- Stage III-IV periodontitis; Stage 3 and 4 patients with ≥15 teeth in their mouth, with CAL ≥5 and PPD ≥6 in at least 6 areas, and radiographic bone loss extending to the middle or apical third of the root.
Exclusion Criteria:
- Individuals who have undergone periodontal treatment in the last 6 months, have systemic diseases (such as diabetes, parathyroid and thyroid-related endocrine diseases) that may affect periodontal status, patients with chronic liver disease, hypoparathyroidism and renal failure, those who have been using medications that may affect periodontal response (aspirin, non-steroidal anti-inflammatory drugs or steroids) for a long time, those who are using additional vitamin D or calcium supplements in the pre-study phase, those who are pregnant or breastfeeding, and those with hypercalcemia and malabsorption syndrome will not be included in the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Group 1: Stage I-II periodontitis group with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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Expérimental: Group 2: Stage I-II periodontitis group with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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Expérimental: Group 3: Stage III-IV periodontitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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Expérimental: Group 4: Stage III-IV periodontitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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Expérimental: Group 5: Chronic gingivitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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Expérimental: Group 6: Chronic gingivitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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Expérimental: Group 7: Periodontally healthy group with sufficient vitamin D levels
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Participants will receive oral hygiene education
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Expérimental: Group 8: Periodontally healthy group with vitamin D deficiency
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Participants will receive oral hygiene education
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Probing pocket depth (PPD)
Délai: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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Clinical attachment level (CAL)
Délai: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Collection of gingival crevicular fluid and serum samples
Délai: These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
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These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KAD-FR-42
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur Non-surgical periodontal treatment
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ALK-Abelló A/SComplétéAllergie | Rhinite | Conjonctivite | Rhinoconjonctivite