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CompletedNCT06867250Updated Mar 10, 2025

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

An observational study in Peri-Implantitis and Peri-implant Mucositis, sponsored by Altinbas University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Altinbas University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Peri-Implantitis and Peri-implant Mucositis

Keywords

  • peri-implant sulcus fluid
  • peri-implant diseases
  • LL-37
  • 25(OH)D
03

In context

Mucositis

488 studies on the registry are indexed under Mucositis; 70 are open to participants now.

This study's enrollment of 33 is below the median of 102 across 66 observational studies indexed under Mucositis.

Browse Mucositis studies →

Lead sponsor

Altinbas University is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • Uncontrolled systemic conditions, disorders affecting peri-implant tissues, metabolic bone diseases, autoimmune disorders.
  • Pregnancy or breastfeeding.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
33 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testThe 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.

    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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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

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

  3. Mucosal Inflammation

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

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

  4. Probing Pocket Depth

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

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

  5. Width of Keratinized Mucosa

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

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

07

Study locations

1 site
  • Altinbas University
    Istanbul, BAKIRKOy 34147, Turkey
08

References and documents

Individual participant data

Plan to share: No — This detailed description provides a comprehensive overview of your study, outlining its objectives, background, methodology, and expected outcomes in a structured and academic manner.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06867250
Lead sponsor
Altinbas University
Responsible party
ILKNUR OZENCI (Assistant professor, Altinbas University) — Principal investigator
First posted
Mar 10, 2025
Start date
Apr 1, 2021
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021
Last update
Mar 10, 2025

Study contacts

ILKNUR OZENCI, Dr
principal investigator · Altinbas University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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