Vitamin D Deficiency Clinical Trial
Official title:
Vitamin-D Insufficiency Leads to Interleukin-10 Reduction in Peri-implant Tissues: A Case-Control Study
Verified date | June 2024 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Vitamin D is important for bone health, immune function, and inflammation, along with dental implant success. The study aimed to assess bone markers and cytokine levels in patients with and without vitamin D insufficiency to better understand the effects of vitamin D levels on dental implant integration. The study included 42 patients in 2 groups; with insufficient (Group IN-S; n=21) and sufficient (Group S; n=21) levels of vitamin D. Bone remodelling, proinflammatory and antiinflammatory markers were analyzed in bone and peri-implant crevicular fluid (PICF) using enzyme-linked immunosorbent assay (ELISA) and results were reported as concentration and total amount.
Status | Completed |
Enrollment | 42 |
Est. completion date | October 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: Being volunteer to participate in the study, For the Vitamin D sufficient group (Group S) having a vitamin D level >20 ng/ml; and 12-20 ng/ml for Vitamin D insufficient group (Groups IN-S). Having sufficient bone height and width at the edentulous areas, Not having a systemic disease that may adversely affect osseointegration, Not smoking Maintaining oral hygiene Exclusion Criteria: Vitamin D deficient patients (<12 ng/ml), already using vitamin D supplements Presence of any systemic disease, such as uncontrolled diabetes, that may affect implant success, Smoking, Presence of untreated periodontitis, Previous exposure to radiotherapy in the head and neck area, Presence of osteoporosis or other metabolic bone diseases, Usage of oral/intravenous bisphosphonates, History of bone grafting and/or sinus lift, Long-term corticosteroid usage. |
Country | Name | City | State |
---|---|---|---|
Turkey | Inonu University | Malatya |
Lead Sponsor | Collaborator |
---|---|
Vesile Elif Toy | Inonu University |
Turkey,
Akkaya HU, Yilmaz HE, Narin F, Saglam M. Evaluation of galectin-3, peptidylarginine deiminase-4, and tumor necrosis factor-alpha levels in gingival crevicular fluid for periodontal health, gingivitis, and Stage III Grade C periodontitis: A pilot study. J Periodontol. 2022 Jan;93(1):80-88. doi: 10.1002/JPER.21-0137. Epub 2021 May 10. — View Citation
Franco-Topete R, Zepeda-Nuno JS, Zamora-Perez AL, Fuentes-Lerma MG, Gomez-Meda BC, Guerrero-Velazquez C. IFN-gammaR2 is strongly expressed on endothelial cells of gingival tissues from patients with chronic periodontitis. J Appl Oral Sci. 2018 Oct 4;26:e20170291. doi: 10.1590/1678-7757-2017-0291. — View Citation
Kwiatek J, Jaron A, Trybek G. Impact of the 25-Hydroxycholecalciferol Concentration and Vitamin D Deficiency Treatment on Changes in the Bone Level at the Implant Site during the Process of Osseointegration: A Prospective, Randomized, Controlled Clinical Trial. J Clin Med. 2021 Feb 2;10(3):526. doi: 10.3390/jcm10030526. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from baseline to 3 months for IL10 and RANKL | PICF and bone levels of markers were measured at baseline and at 3 months in both groups | 0 to 3 months | |
Primary | change from baseline to 3 months for RFA | Measurement of primary and secondary implant stability were performed at baseline and at 3 months in both groups | 0 to 3 months |
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