Vitamin-D Insufficiency and Implants

NCT06452251 | Completed DMC

• 1 other identifier: TSA-2022-2992
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

vitamin D sufficient

Vitamin D sufficient group (Group S) \>20 ng/ml threshold was determined as sufficiency,

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

vitamin d insufficient

Vitamin D insufficient group (Group IN-S) 12-20 ng/mol was determined as insufficiency.

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

Interventions

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

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.

vitamin D sufficient; vitamin d insufficient

Resonance Frequency Analysis DIAGNOSTIC_TEST

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.

vitamin D sufficient; vitamin d insufficient

Periodontal clinical examination DIAGNOSTIC_TEST

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.

vitamin D sufficient; vitamin d insufficient

Dental implant placement and bone sample collection PROCEDURE

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).

vitamin D sufficient; vitamin d insufficient

Gingival Crevicular Fluid Sampling PROCEDURE

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.

vitamin D sufficient; vitamin d insufficient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vesile Elif Toy: lead
• Inonu University: collaborator

Study Sites (1)

Inonu University

Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33913157 BACKGROUND

• 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.

  PMID: 33540512 BACKGROUND

• 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.

  PMID: 30304122 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Peri-Implantitis

Interventions

Radiography, Panoramic

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Radiography, Dental; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnosis, Oral; Dentistry

Study Officials

• Vesile E Toy, Phd

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisstant professor

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 11, 2024
• Study Start: January 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data is currently available.
• Access Criteria: Individual participant data can be shared upon reasonable request.

Locations

TU (1)