Peri-implant Vitamin D and Cathelicidin (LL-37) Levels

NCT06867250 | Completed DMC

• 1 other identifier: 2021/45
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to explore the influence of vitamin D on the body's defense system by examining its impact on specific proteins involved in immune response and inflammation in the soft tissues surrounding dental implants. Also aims to determine how vitamin D levels affect these proteins and their role in protecting peri-implant tissues from microbial infections and inflammation.

Conditions

Peri-Implantitis and Peri-implant Mucositis

Keywords

peri-implant sulcus fluid; peri-implant diseases; LL-37; 25(OH)D

Outcome Measures

Primary Outcomes (5)

• Peri-implant sulcus fluid vitamin D levels and clinical parameters correlation

  The association between vitamin D levels in peri-implant sulcus fluid and clinical parameters in individuals with peri-implant health and peri-implant diseases.

  At the day of visit (Day 0)- Peri-implant clinical assessments and peri-implant sulcus fluid collection

• The correlation between vitamin D and the antimicrobial peptide LL-37

  Peri-implant sulcus fluid Vitamin d and LL-37 levels were investigated with ELISA

  Laboratory tests were completed after all samples were collected.

• Mucosal Inflammation

  Measurement of mucosal inflammation around implants using modified plaque index (mPI), and modified sulcus bleeding index (mSBI).

  At the day of visit (Day 0)

• Probing Pocket Depth

  Measurement of the periodontal pockets depth around implants. Unit of Measure: Millimeters (mm)

  At the day of visit (Day 0)

• Width of Keratinized Mucosa

  Measurement of the width of keratinized mucosa around the implants. Unit of Measure: Millimeters (mm)

  At the day of visit (Day 0)

Study Arms (1)

peri-implant healthy, peri-implant mucositis, peri-implantitis

A total of 105 dental implants from 33 patients were assessed, with 35 categorized in the peri-implant health group, 35 in the peri-implant mucositis group, and 35 in the peri-implantitis group.

Diagnostic Test: The patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay.

Interventions

The patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay. DIAGNOSTIC_TEST

In vitro studies have shown that vitamin D promotes the release of antimicrobial peptides from gingival epithelial cells, no clinical research has specifically examined its effect on LL-37 levels in peri-implant tissue diseases. This study seeks to investigate the relationship between vitamin D levels in peri-implant sulcus fluid and clinical parameters in individuals with both peri-implant health and disease. Additionally, it aims to assess the correlation between vitamin D and the antimicrobial peptide LL-37.

peri-implant healthy, peri-implant mucositis, peri-implantitis

Eligibility Criteria

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

Study Population

This cross-sectional clinical study included 33 patients with dental implants, exhibiting either healthy peri-implant tissues or peri-implant diseases, who sought treatment at the Department of Periodontology, Faculty of Dentistry, Altınbaş University.

You may qualify if:

• Not received peri-implant treatment in the previous six months.
• Had not used vitamin D supplements, antibiotics, anti-inflammatory drugs, or any medications that could affect peri-implant tissues in the last three months.
• Patients with dental implants had been in function for at least 12 months, had been under functional loading for at least six months, and had prosthetic superstructures that allowed for unobstructed sample collection.

You may not qualify if:

• Uncontrolled systemic conditions, disorders affecting peri-implant tissues, metabolic bone diseases, autoimmune disorders.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Altinbas University: lead

Study Sites (1)

Altinbas University

Istanbul, BAKIRKOy, 34147, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peri-implant sulcus fluid

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• ILKNUR OZENCI, Dr

  Altinbas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 10, 2025
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)