Skip to content

Vitamin-D Insufficiency and Implants

Vitamin-D Insufficiency Leads to Interleukin-10 Reduction in Peri-implant Tissues: A Case-Control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06452251
Enrollment
42
Registered
2024-06-11
Start date
2022-01-01
Completion date
2023-10-01
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency, Osseointegration Failure of Dental Implant, Peri-Implantitis

Keywords

RANKL, calcium, IL-10, vitamin D, osseointegration

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.

Interventions

DIAGNOSTIC_TESTOPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA

The levels of OPG, OC, RANKL, IL10, IL1β, Ca, TNF-α and Caspase1 in bone and PICF of patients with or without Vitamin D sufficiency were measured by ELISA.

Implant stability was measured by a device (Penguin RFA, Integration Diagnostics, Sweden) based on Resonance Frequency Analysis (RFA) and categorized by Implant Stability Quotient (ISQ) scale.

DIAGNOSTIC_TESTPeriodontal clinical examination

Clinical periodontal indices including plaque index (PI) (Silness and Löe 1964), gingival index (GI) (Löe 1967), probing depth (PD), and bleeding on probing (BOP) (Ainamo and Bay 1975) were recorded using a Williams periodontal probe. The BOP percentage (%) was calculated by dividing the number of bleeding sites by the total number of sites examined.

PROCEDUREDental implant placement and bone sample collection

All patients were received by a single examiner a bone level implant (standard type and Sandblasted, Large-grit, Acid-etched surface) (Implant Swiss, Yverdon, Switzerland).

One month after the healing caps were inserted, peri-implant crevicular fluid (PISF) samples were collected from 6 different sides of each implant. Before sampling, the area was isolated and dried, and paper strips were gently kept in periimplant sulcus for 30 seconds. Strips with blood or saliva contamination were discarded. PISF volumes of each strip were measured by a device (Periotron 8,010, Oraflow Inc, USA). Strips were then pooled, and inserted into tubes. PISF was recovered from paper strips through agitation in phosphate buffer saline (50 mM Tris-HCl, 5 mM CaCl2, 0.2 M NaCl,pH 7.5). All samples were stored at -80C until the day of analysis.

Sponsors

Inonu University
CollaboratorOTHER
Vesile Elif Toy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
change from baseline to 3 months for IL10 and RANKL0 to 3 monthsPICF and bone levels of markers were measured at baseline and at 3 months in both groups
change from baseline to 3 months for RFA0 to 3 monthsMeasurement of primary and secondary implant stability were performed at baseline and at 3 months in both groups

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026