Clinical trial NCT06452251: Vitamin-D Insufficiency and Implants
Official title: Vitamin-D Insufficiency Leads to Interleukin-10 Reduction in Peri-implant Tissues: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Osseointegration Failure of Dental Implant
Peri-Implantitis
Keywords: RANKL
calcium
IL-10
vitamin D
osseointegration
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2024-06-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the Vitamin D sufficient group (Group S) \>20 ng/ml threshold was determined as vitamin D sufficient, and Vitamin D insufficient group (Groups IN-S) 12-20 ng/mol was determined as insufficient. Vitamin D deficient patients (\<12 ng/ml), already using vitamin D supplements, were not included in the current study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline to 3 months for IL10 and RANKL
timeFrame: 0 to 3 months
measure: change from baseline to 3 months for RFA
timeFrame: 0 to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Vesile E Toy, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.