Sphingosine 1-phosphateNCT06930430
IL-1β and S1P Levels After Periodontal Therapy: A Split-Mouth Study
A study testing Non-Surgical Periodontal Therapy (NSPT) in people with Sphingosine 1-phosphate and Interleukin 1-beta, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sphingosine 1-phosphate, Interleukin 1-beta, Gingival Crevicular Fluid
- What is being tested?
- Non-Surgical Periodontal Therapy (NSPT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University
Samsun, Atakum, 55200
About this study
Official title: Gingival Crevicular Fluid Sphingosine-1-phosphate and Interleukin-1 Beta Levels After Non-surgical Periodontal Therapy: a Split-mouth Randomized Trial
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.
Read the 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.
- Conditions
- Sphingosine 1-phosphate, Interleukin 1-beta, Gingival Crevicular Fluid, Non-surgical Periodontal Therapy, Split-mouth Design
- Being tested
- Non-Surgical Periodontal Therapy (NSPT)
- Keywords
- gingival crevicular fluid, sphingosine-1-phosphate, interleukin-1 beta, non-surgical periodontal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal Therapy (NSPT)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Non-Surgical Periodontal Therapy (NSPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (3)
Correlation between IL-1β and S1P levels in gingival crevicular fluid (GCF)
The study evaluated the statistical correlation between IL-1β and S1P concentrations in gingival crevicular fluid (GCF) samples collected from diseased and periodontally healthy sites at baseline and 3 months after non-surgical periodontal therapy (NSPT).
Measured: Baseline, and 3 months
Correlation of S1P and IL-1β levels with clinical periodontal parameters
The levels of S1P and IL-1β in gingival crevicular fluid (GCF) were analyzed for correlation with clinical periodontal indices, including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), and GCF volume. Correlations were evaluated at baseline and 3 months following non-surgical periodontal therapy (NSPT) to assess the association between inflammatory biomarkers and clinical disease activity.
Measured: Baseline, and 3 months
Change in clinical periodontal parameters following non-surgical periodontal therapy (NSPT)
Plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), and GCF volume were recorded at diseased and healthy sites to assess periodontal status. These parameters were evaluated at baseline, 1 month, and 3 months after treatment to monitor clinical response to therapy.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start15 May 2023
- Primary completion18 Apr 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphingosine 1-phosphateStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atanur Sarioglu, Ondokuz Mayıs University
- Investigators
- Atanur Sarioglu, DDS, Principal investigator, Ondokuz Mayıs University, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930430
- Sponsor's protocol ID
- OMU KAEK protokol no: 2023/96
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid Sphingosine-1-phosphate and Interleukin-1 Beta Levels After Non-surgical Periodontal Therapy: a Split-mouth Randomized Trial
- ClinicalTrials.gov ID
- NCT06930430
- Acronym / sponsor ID
- OMU KAEK protokol no: 2023/96
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stage III Periodontitis Patients | Other | Procedure: Non-Surgical Periodontal Therapy (NSPT)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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 [+])
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Surgical Periodontal Therapy (NSPT)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. | Procedure or surgery | Stage III Periodontitis Patients |
Primary outcome
Change in gingival crevicular fluid (GCF) sphingosine-1-phosphate (S1P) levels
Time frame: Baseline, 1 month, and 3 months
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).
Change in gingival crevicular fluid (GCF) interleukin-1 beta (IL-1β) levels
Time frame: Baseline, 1 month, and 3 months
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).
3 secondary outcomes
Correlation between IL-1β and S1P levels in gingival crevicular fluid (GCF)
Time frame: Baseline, and 3 months
Correlation of S1P and IL-1β levels with clinical periodontal parameters
Time frame: Baseline, and 3 months
Change in clinical periodontal parameters following non-surgical periodontal therapy (NSPT)
Time frame: Baseline, 1 month, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atanur Sarioglu, DDS principal investigator
Ondokuz Mayıs University, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Therapy (NSPT) in people with Sphingosine 1-phosphate and Interleukin 1-beta, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gingival crevicular fluid (GCF) sphingosine-1-phosphate (S1P) levels (time frame: Baseline, 1 month, and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.