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NCT Number: NCT06867250

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

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.

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Key information

Conditions

Peri-Implantitis and Peri-implant Mucositis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Altinbas University

Istanbul, BAKIRKOy, 34147, Turkey (Türkiye)

About this study

This cross-sectional clinical study examined 33 patients with 105 dental implants, classified as having either healthy peri-implant tissues or peri-implant diseases. Participants had not received peri-implant treatment in the past six months or taken medications affecting peri-implant tissues in the last three months. Eligible implants had been functional for at least 12 months with prosthetic superstructures that allowed sample collection. Patients with uncontrolled systemic conditions, metabolic bone diseases, autoimmune disorders, or those who were pregnant or breastfeeding were excluded.

Clinical assessments were conducted at six peri-implant sites, measuring probing depth (PD), clinical attachment level (CAL), modified plaque index (mPI), modified sulcus bleeding index (mSBI), and keratinized mucosa width (KMW). Bone loss was evaluated using radiographs. Patients were categorized into three groups based on the 2017 Classification of Periodontal and Peri-implant Diseases: peri-implant health, peri-implant mucositis, and peri-implantitis (35 implants per group).

Peri-implant sulcus fluid (PISF) samples were collected for 25(OH)D and LL-37 analysis using enzyme-linked immunosorbent assay (ELISA). Statistical analysis included normality tests (Kolmogorov-Smirnov), descriptive statistics, one-way ANOVA with Tukey HSD, Kruskal-Wallis with Dunn's test, chi-square tests, and Spearman's correlation for non-normally distributed data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

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

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

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

    Time frame: Laboratory tests were completed after all samples were collected.

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

  3. Mucosal Inflammation

    Time frame: At the day of visit (Day 0)

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

  4. Probing Pocket Depth

    Time frame: At the day of visit (Day 0)

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

  5. Width of Keratinized Mucosa

    Time frame: At the day of visit (Day 0)

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

Sponsors and collaborators

Lead sponsor

Altinbas University

Other

Registry information

Official study title

Evaluation of Peri-Implant Sulcus Fluid Vitamin D and Cathelicidin (LL-37) Levels in Peri-Implant Health and Diseases

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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