Vitamin-D Insufficiency and Implants

Completed

• Conditions: Osseointegration Failure of Dental Implant; Vitamin D Deficiency; Peri-Implantitis
• Interventions: Diagnostic Test: OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA; Diagnostic Test: Resonance Frequency Analysis; Diagnostic Test: Periodontal clinical examination; Procedure: Dental implant placement and bone sample collection; Procedure: Gingival Crevicular Fluid Sampling

• Registration Number: NCT06452251
• Lead Sponsor: Vesile Elif Toy

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 Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-10-01
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vitamin D sufficient	OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA	Vitamin D sufficient group (Group S) \>20 ng/ml threshold was determined as sufficiency,
vitamin D sufficient	Resonance Frequency Analysis	Vitamin D sufficient group (Group S) \>20 ng/ml threshold was determined as sufficiency,
vitamin d insufficient	OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA	Vitamin D insufficient group (Group IN-S) 12-20 ng/mol was determined as insufficiency.
vitamin D sufficient	Dental implant placement and bone sample collection	Vitamin D sufficient group (Group S) \>20 ng/ml threshold was determined as sufficiency,
vitamin d insufficient	Resonance Frequency Analysis	Vitamin D insufficient group (Group IN-S) 12-20 ng/mol was determined as insufficiency.
vitamin d insufficient	Gingival Crevicular Fluid Sampling	Vitamin D insufficient group (Group IN-S) 12-20 ng/mol was determined as insufficiency.
vitamin d insufficient	Dental implant placement and bone sample collection	Vitamin D insufficient group (Group IN-S) 12-20 ng/mol was determined as insufficiency.
vitamin D sufficient	Gingival Crevicular Fluid Sampling	Vitamin D sufficient group (Group S) \>20 ng/ml threshold was determined as sufficiency,
vitamin D sufficient	Periodontal clinical examination	Vitamin D sufficient group (Group S) \>20 ng/ml threshold was determined as sufficiency,
vitamin d insufficient	Periodontal clinical examination	Vitamin D insufficient group (Group IN-S) 12-20 ng/mol was determined as insufficiency.

Primary Outcome Measures

Name	Time	Method
change from baseline to 3 months for IL10 and RANKL	0 to 3 months	PICF and bone levels of markers were measured at baseline and at 3 months in both groups
change from baseline to 3 months for RFA	0 to 3 months	Measurement of primary and secondary implant stability were performed at baseline and at 3 months in both groups

Trial Locations

Locations (1)

Inonu University; 🇹🇷 Malatya, Turkey