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The Effect of Vitamin D Levels and Supplementation on Anti-inflammatory Response in Periodontal Disease: a Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Turkey
Recep Tayyip Erdoğan University
RECRUITING
Rize
Contact Information
Primary
Hatice Yemenoglu
htcymnglu@hotmail.com
+905052977517
Time Frame
Start Date: 2026-06-03
Estimated Completion Date: 2026-10-16
Participants
Target number of participants: 120
Treatments
Experimental: Group 1: Stage I-II periodontitis group with vitamin D deficiency
Experimental: Group 2: Stage I-II periodontitis group with vitamin D deficiency
Experimental: Group 3: Stage III-IV periodontitis with vitamin D deficiency
Experimental: Group 4: Stage III-IV periodontitis with vitamin D deficiency
Experimental: Group 5: Chronic gingivitis with vitamin D deficiency
Experimental: Group 6: Chronic gingivitis with vitamin D deficiency
Experimental: Group 7: Periodontally healthy group with sufficient vitamin D levels
Experimental: Group 8: Periodontally healthy group with vitamin D deficiency
Related Therapeutic Areas
Sponsors
Leads: Recep Tayyip Erdogan University Training and Research Hospital

This content was sourced from clinicaltrials.gov