Clinical trial NCT06930430: IL-1β and S1P Levels After Periodontal Therapy: A Split-Mouth Study
Official title: Gingival Crevicular Fluid Sphingosine-1-phosphate and Interleukin-1 Beta Levels After Non-surgical Periodontal Therapy: a Split-mouth Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sphingosine 1-phosphate
Interleukin 1-beta
Gingival Crevicular Fluid
Non-surgical Periodontal Therapy
Split-mouth Design
Keywords: gingival crevicular fluid
sphingosine-1-phosphate
interleukin-1 beta
non-surgical periodontal therapy
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 17
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study followed a single group, split-mouth design. Seventeen systemically healthy, non-smoking patients with stage III periodontitis were included. For each participant, three periodontally diseased sites (with PD ≥ 6 mm and CAL ≥ 5 mm) and three periodontally healthy control sites (with PD ≤ 3 mm and no CAL) were selected. This resulted in a total of 51 diseased and 51 healthy sites for comparative evaluation. All patients received full-mouth non-surgical periodontal therapy. Biochemical and clinical outcomes were assessed longitudinally at baseline, 1 month, and 3 months.
Primary purpose: TREATMENT

Brief summary: This randomized split-mouth clinical trial aimed to evaluate the changes in interleukin-1 beta (IL-1β) and sphingosine-1-phosphate (S1P) levels in gingival crevicular fluid (GCF) following non-surgical periodontal therapy (NSPT) in patients with stage III periodontitis. A total of 17 systemically healthy, non-smoking individuals were included. For each patient, three diseased and three healthy periodontal sites were selected, totaling 51 diseased and 51 healthy sites for biochemical and clinical evaluation.

GCF samples and clinical periodontal parameters were collected at baseline, one month, and three months after NSPT. The levels of IL-1β and S1P were quantified using enzyme-linked immunosorbent assay (ELISA). The study also investigated the correlation between biomarker levels and clinical indicators of periodontal disease severity, such as probing depth and clinical attachment level.

Detailed description: Diseased sites were selected based on the most severe clinical findings, including probing depth (PD) of ≥6 mm, clinical attachment level (CAL) of ≥5 mm, and the presence of bleeding on probing (BOP). Healthy sites were defined by PD ≤3 mm, no clinical attachment loss, absence of radiographic bone loss, and BOP negativity. All selected sites were non-adjacent and distributed throughout the oral cavity to reduce regional bias.

This study also aimed to explore site-specific changes in biomarker expression over time and assess the correlation between GCF IL-1β/S1P levels and clinical indicators of periodontal disease severity and healing response. All GCF sampling was repeated from the same sites at each time point. Control (healthy) site sampling was done at baseline and 3 months, while diseased site sampling was conducted at baseline, 1 month, and 3 months.

Eligibility criteria: Inclusion Criteria:

* Aged between 45 and 60 years
* Systemically healthy individuals with no known systemic conditions
* Non-smokers or former smokers who had quit at least two years prior
* Diagnosed with Stage III periodontitis according to the 2017 World Workshop Classification
* Presence of at least three diseased sites with probing depth (PD) ≥ 6 mm, clinical attachment level (CAL) ≥ 5 mm, and bleeding on probing (BOP \[+\])
* Presence of at least three periodontally healthy sites with PD ≤ 3 mm, no CAL, and no BOP
* No periodontal treatment within the last 6 months
* Provided written informed consent

Exclusion Criteria:

* Presence of systemic diseases known to affect periodontal status (e.g., diabetes mellitus, cardiovascular disease, autoimmune disorders)
* Use of antibiotics or anti-inflammatory medications within the last 6 months
* History of periodontal surgery within the past 12 months
* Pregnant or lactating women
* Current smokers or individuals who quit less than two years ago
* Sites with endodontic lesions, caries extending to the cervical area, trauma-related gingival recession, or bone loss due to non-periodontal causes
* Undergoing orthodontic treatment during the study period

Primary outcomes:
measure: Change in gingival crevicular fluid (GCF) sphingosine-1-phosphate (S1P) levels
timeFrame: Baseline, 1 month, and 3 months
measure: Change in gingival crevicular fluid (GCF) interleukin-1 beta (IL-1β) levels
timeFrame: Baseline, 1 month, and 3 months
Secondary outcomes:
measure: Correlation between IL-1β and S1P levels in gingival crevicular fluid (GCF)
timeFrame: Baseline, and 3 months
measure: Correlation of S1P and IL-1β levels with clinical periodontal parameters
timeFrame: Baseline, and 3 months
measure: Change in clinical periodontal parameters following non-surgical periodontal therapy (NSPT)
timeFrame: Baseline, 1 month, and 3 months
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University, Department of Periodontology
name: Atanur Sarioglu, DDS
role: PRINCIPAL_INVESTIGATOR
References: