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

March 7, 2025 updated by: ILKNUR OZENCI, Altinbas University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • BAKIRKOy
      • Istanbul, BAKIRKOy, Turkey, 34147
        • Altinbas University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
Laboratory tests were completed after all samples were collected.
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).
At the day of visit (Day 0)
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)
At the day of visit (Day 0)
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)
At the day of visit (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altinbas University

Investigators

  • Principal Investigator: ILKNUR OZENCI, Dr, Altinbas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This detailed description provides a comprehensive overview of your study, outlining its objectives, background, methodology, and expected outcomes in a structured and academic manner.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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