IL-1β and S1P Levels After Periodontal Therapy: A Split-Mouth Study

NCT06930430 | Completed

• 1 other identifier: OMU KAEK protokol no: 2023/96
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Change in gingival crevicular fluid (GCF) sphingosine-1-phosphate (S1P) levels

  S1P levels in gingival crevicular fluid (GCF) were measured using ELISA at diseased and periodontally healthy sites. Changes were evaluated at baseline, 1 month, and 3 months following non-surgical periodontal therapy (NSPT).

  Baseline, 1 month, and 3 months

• Change in gingival crevicular fluid (GCF) interleukin-1 beta (IL-1β) levels

  IL-1β levels in gingival crevicular fluid (GCF) were quantified via ELISA at both diseased and periodontally healthy sites. Changes were evaluated at baseline, 1 month, and 3 months following non-surgical periodontal therapy (NSPT).

  Baseline, 1 month, and 3 months

Secondary Outcomes (3)

• Correlation between IL-1β and S1P levels in gingival crevicular fluid (GCF)

  Baseline, and 3 months

• Correlation of S1P and IL-1β levels with clinical periodontal parameters

  Baseline, and 3 months

• Change in clinical periodontal parameters following non-surgical periodontal therapy (NSPT)

  Baseline, 1 month, and 3 months

Study Arms (1)

Stage III Periodontitis Patients

OTHER

This arm included 17 systemically healthy, non-smoking patients diagnosed with stage III periodontitis. Each participant contributed three periodontally diseased sites and three periodontally healthy sites, resulting in a total of 51 diseased and 51 healthy sites for evaluation. All patients received full-mouth non-surgical periodontal therapy. Clinical and biochemical parameters were assessed at baseline, 1 month, and 3 months.

Procedure: Non-Surgical Periodontal Therapy (NSPT)

Interventions

Non-Surgical Periodontal Therapy (NSPT) PROCEDURE

Scaling and root planing was performed using hand instruments under local anesthesia, if necessary. Oral hygiene instructions were provided using the modified Bass technique. GCF samples were collected from the same sites at baseline, 1 month, and 3 months to measure levels of IL-1β and S1P using ELISA.

Stage III Periodontitis Patients

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Study Officials

• Atanur Sarioglu, DDS

  Ondokuz Mayıs University, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: May 15, 2023
• Primary Completion: April 18, 2024
• Study Completion: September 10, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)