Clinical trial NCT06867250: Peri-implant Vitamin D and Cathelicidin (LL-37) Levels
Official title: Evaluation of Peri-Implant Sulcus Fluid Vitamin D and Cathelicidin (LL-37) Levels in Peri-Implant Health and Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implantitis and Peri-implant Mucositis
Keywords: peri-implant sulcus fluid
peri-implant diseases
LL-37
25(OH)D
Lead sponsor: Altinbas University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peri-implant sulcus fluid vitamin D levels and clinical parameters correlation
timeFrame: At the day of visit (Day 0)- Peri-implant clinical assessments and peri-implant sulcus fluid collection
measure: The correlation between vitamin D and the antimicrobial peptide LL-37
timeFrame: Laboratory tests were completed after all samples were collected.
measure: Mucosal Inflammation
timeFrame: At the day of visit (Day 0)
measure: Probing Pocket Depth
timeFrame: At the day of visit (Day 0)
measure: Width of Keratinized Mucosa
timeFrame: At the day of visit (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Altinbas University
state: BAKIRKOy
Study officials:
affiliation: Altinbas University
name: ILKNUR OZENCI, Dr
role: PRINCIPAL_INVESTIGATOR
References: