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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Hatice Yemenoglu
- Telefonnummer: +905052977517
- E-post: htcymnglu@hotmail.com
Studieorter
-
-
-
Rize, Turkiet (Türkiye), 53020
- Rekrytering
- Recep Tayyip Erdogan University
-
Kontakt:
- Hatice Yemenoglu
- Telefonnummer: +904642220000
- E-post: htcymnglu@hotmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group 1: Stage I-II periodontitis group with vitamin D deficiency
|
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
|
|
Experimentell: Group 2: Stage I-II periodontitis group with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
|
|
Experimentell: Group 3: Stage III-IV periodontitis with vitamin D deficiency
|
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
|
|
Experimentell: Group 4: Stage III-IV periodontitis with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
|
|
Experimentell: Group 5: Chronic gingivitis with vitamin D deficiency
|
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
|
|
Experimentell: Group 6: Chronic gingivitis with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
|
|
Experimentell: Group 7: Periodontally healthy group with sufficient vitamin D levels
|
Participants will receive oral hygiene education
|
|
Experimentell: Group 8: Periodontally healthy group with vitamin D deficiency
|
Participants will receive oral hygiene education
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Probing pocket depth (PPD)
Tidsram: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
|
These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
|
|
Clinical attachment level (CAL)
Tidsram: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
|
These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Collection of gingival crevicular fluid and serum samples
Tidsram: These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
|
These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KAD-FR-42
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .