Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT06452251
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2024-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin-D Insufficiency and Implants
Sponsor:
Vesile Elif Toy
Organization:
Study Overview
Official Title:
Vitamin-D Insufficiency Leads to Interleukin-10 Reduction in Peri-implant Tissues: A Case-Control Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Background: Vitamin D is crucial for bone mineralization and plays a significant role in immune and inflammatory responses. Its deficiency is highly prevalent and might alter osseointegration of dental implants. Since successful osseointegration is a critical aspect of implant survival and the effects of vitamin D on implant osseointegration have not been well documented, the aim of this study was to evaluate bone markers and cytokine levels of patients with or without vitamin D insufficiency. Methods: A total of 42 patients were included and divided into two groups: Vitamin D insufficient (Group IN-S; n=21) and Vitamin D sufficient (Group S; n=21). Besides clinical periodontal parameters and implant stability measurements, bone and peri-implant crevicular fluid (PICF) levels of Receptor Activator of Nuclear Factor Kappa B Ligand (RANKL), osteoprotegerin (OPG), osteocalcin (OC), calcium (Ca), tumour necrosis factor alpha (TNF-α), Interleukin 1β (IL-1β), caspase-1 and Interleukin 10 (IL-10) were determined by enzyme-linked immunosorbent assay (ELISA). Results were represented as concentration and total amount.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: