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临床试验/NCT06867250
NCT06867250已完成不适用

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

Altinbas University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
Peri-implant sulcus fluid vitamin D levels and clinical parameters correlation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 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.

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

时间窗: Laboratory tests were completed after all samples were collected.

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

Mucosal Inflammation

时间窗: At the day of visit (Day 0)

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

Probing Pocket Depth

时间窗: At the day of visit (Day 0)

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

Width of Keratinized Mucosa

时间窗: At the day of visit (Day 0)

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

次要结局

未报告次要终点

研究者

发起方
Altinbas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ILKNUR OZENCI

Assistant professor

Altinbas University

研究点 (1)

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