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Periodontitis, AdultNCT06351722

Non-surgical Periodontal Treatment in Smokers on SIRT-1, NLRP3 Inflammasome and LncRNAs

An observational study of Periodontitis, Adult, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational is to analyze the relationship between levels of interleukin-18 (IL-18), interleukin (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), interleukin-10 (IL-10), transforming growth factor beta (TGF-β), Nucleotide-binding oligomerization domain -like receptor protein 3 (NLRP3)… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis, Adult
What is being tested?
Before non-surgical periodontal treatment, non-surgical periodontal treatment and 3rd month after non-surgical periodontal treatment
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jun 2024to 15 Jul 2026
How long will I take part?
3 Months
Phase
Observational
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: This study is planned to be conducted with 100 individuals aged between 18 and 65 who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, for various reasons. The eligibility of individuals to be included in the study will be evaluated by Dr. Zeynep TAŞTAN EROĞLU at the Periodontology Clinic of NEU Faculty of Dentistry.

Who may be able to join

  • Being between the ages of 18 and 65
  • Being diagnosed as "periodontally healthy" or "periodontitis" based on periodontal examination
  • Not having any accompanying systemic diseases (such as diabetes, cardiovascular diseases, etc.)
  • Agreeing to participate in the study

Who cannot join

  • Use of contraceptive medications
  • Use of anti-inflammatory, antibiotic, immunosuppressive, or other medications - that could affect the study outcomes within the previous 6 months
  • History of excessive alcohol consumption
  • Pregnancy or breastfeeding
  • Undergoing periodontal treatment within the previous 6 months
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology

    Konya

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Non-surgical Periodontal Treatment in Smokers on SIRT-1 and Proteins of the NLRP3 Inflammasome and Long Noncoding RNAs

The goal of this observational is to analyze the relationship between levels of interleukin-18 (IL-18), interleukin (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), interleukin-10 (IL-10), transforming growth factor beta (TGF-β), Nucleotide-binding oligomerization domain -like receptor protein 3 (NLRP3), apoptosis-associated speck-like protein (ASC), caspase-1, Sirtuin 1 (SIRT-1), Long noncoding RNA (lncRNA) small nucleolar RNA host gene 5 (SNHG5), and maternally expressed gene 3 (MEG3) in saliva, serum, and peripheral mononuclear blood cell (PMBC)in patients with periodontitis and smokers, to examine the changes in these biomarkers after non surgical periodontal treatment (NSPT), and to evaluate potential confounders that may mediate this relationship.

The main questions it aims to answer are:

question 1: Is there a relationship between the biomarkers mentioned above and periodontitis and smoking? question 2:How do the above-mentioned biomarkers change after NSPT in smokers and non-smokers?

Read the detailed description

There will be 4 groups in the study: Non-smoking periodontitis (NSP), smoking periodontitis (SP), non-smoking healthy control (HC), and smoking healthy control (HCS).

The periodontitis groups in the study (NSP and SP) will include patients diagnosed with Stage II and III, generalized, Grade B, C periodontitis clinically based on the consensus report of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and systemically healthy individuals. Patients with clinical attachment loss ≥3 mm in >30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included. Patients with periodontal disease-related tooth loss ≤4 teeth will be included. Disease progression rate will be graded as B or C Class based on direct evidence of disease progression confirmed by panoramic radiographs and evidence of indirect destruction proportional to biofilm accumulations. In the smoking periodontitis group (SP) and smoking healthy group (HCS), participants who reported smoking >10 cigarettes per day for >5 years will be included, while participants in the non-smoking groups (NSP and HC) will be those who reported never smoking.

Clinical Measurements and Non-surgical Periodontal Treatment

Saliva and serum samples will be collected from all patients initially and 3 months after NSPT. Clinical parameters will also be recorded initially and at the 3rd month. Plaque index (PI) and gingival index (GI) will be recorded at four sites per tooth. Full-mouth probing depth (PD) and clinical attachment level (CAL) will be detailed per tooth at six sites, and the percentage of bleeding areas will be recorded as present or absent within 20 seconds after probing using a binary scoring system. A calibrated periodontologist (ZTE) will record all clinical parameters using manual probing. Examiner calibration will be provided before starting the study on a small pilot population to achieve consistent intra-examiner accuracy. After the collection of baseline samples and clinical parameter records, all patients will receive initial periodontal treatment, including patient education, full-mouth scaling, and root planing (SRP), and oral hygiene instructions from the same experienced clinician (ZTE).

Laboratory Measurement

Each patient will be instructed to abstain from eating, drinking, and oral hygiene practices for 12 hours before sampling. Serum and saliva samples will be collected from each patient between 8:00 and 10:00 in the morning before dental examination.

Blood Sampling: In the scope of the study, a total of 5 mL of blood will be collected from the antecubital vein of each individual by an expert nurse from the Department of Periodontology.

For serum sampling, venous puncture will be performed, and blood samples will be collected, immediately cooled on ice, and centrifuged at 4°C (800 rpm for 10 minutes). After the collection of saliva samples, they will be centrifuged immediately at 4°C (1000 rpm for 2 minutes). Following sampling, both serum and saliva samples will be stored at -80°C until analysis. Concentrations of NLRP3, ASC, caspase-1, IL-18, IL-1beta, TNF-alfa, IL-10, TGF-beta, and SIRT-1 will be analyzed by specific enzyme-linked immunosorbent assay (ELISA) kits in both serum and saliva samples. LncRNA SNHG5 and MEG3 will be examined using Real-time polymerase chain reaction (RT-PCR).

IL-18, IL-1beta, TNF-alfa, IL-10, TGF-beta, NLRP3, SIRT-1, lncRNA SNHG5, and MEG3 levels in PMBC will be evaluated using RT-PCR. All analysis steps for each kit will be evaluated using the protocol recommended by the manufacturer.

Statistical Analysis:

Statistical analysis will be performed using commercially available software (SPSS version 22.0, SPSS). In this study, a significance value (p-value) of <0.05 will be used. This study is designed as a prospective controlled clinical trial. The sample size of the study was calculated using the R Statistical Language program (version 4.1.2; The R Foundation for Statistical Computing, Vienna, Austria; http://www.r-project.org). It was planned to include at least 25 individuals in each group for One-Way Analysis of Variance analysis to be conducted with a significance level of 5%, statistical power of 80%, and effect size of 0.4 (Cohen's f=0.4) to determine if there is a significant difference in inflammatory factors between the study groups (smoking periodontitis, smoking periodontally healthy, non-smoking periodontitis, non-smoking periodontally healthy).

Longitudinal analyses will include data only from patients who complete the entire study protocol.

Being tested
Before non-surgical periodontal treatment, non-surgical periodontal treatment, 3rd month after non-surgical periodontal treatment
Keywords
periodontitis, smoking, NLRP3 inflammasome, SIRT1, non-coding RNA
Medical subject headings
Chronic Periodontitis, Periodontitis, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Before non-surgical periodontal treatmentDiagnostic test

    Clinical Measurements and Laboratory Measurement Saliva and serum samples will be collected from all patients initially. Clinical parameters will also be recorded initially. Plaque index (PI) and gingival index (GI) will be recorded at four sites per tooth. Full-mouth probing depth (PD) and clinical attachment level (CAL) will be detailed per tooth at six sites, and the percentage of bleeding areas will be recorded as present or absent within 20 seconds after probing using a binary scoring system. A calibrated periodontologist (ZTE) will record all clinical parameters using manual probing.

    Following sampling, both serum and saliva samples will be stored at -80°C until analysis. Concentrations of NLRP3, ASC, caspase-1, IL-18, IL-1beta, TNF-alfa, IL-10, TGF-beta, and SIRT-1 will be analyzed by specific enzyme-linked immunosorbent assay (ELISA) kits in both serum and saliva samples. LncRNA SNHG5 and MEG3 will be examined using Real-time PCR.

  • non-surgical periodontal treatmentProcedure or surgery

    Treatment will be performed using ultrasonic devices followed by root planing with gracey curettes. SRP will be completed in two visits, each consisting of quadrants every 2 days. Oral hygiene instructions will include demonstrating proper brushing techniques and the use of interdental cleaning aids as needed. Saliva and serum samples will be collected again at the 3-month follow-up visit, all clinical parameter records will be repeated by the same clinician (ZTE), and oral hygiene instructions will be reconfirmed as needed. After the collection of 3-month records and samples, all patients with persistent pockets will be subjected to a standard periodontitis treatment protocol.

  • 3rd month after non-surgical periodontal treatmentDiagnostic test

    All clinical and laboratory evaluations described under the heading "Before non-surgical periodontal treatment" will be repeated in the 3rd month after NSPT.

Study groups in NCT06351722
Study groupRoleWhat they receive
Non-smoking periodontitis (NSP)participants who reported never smoking, with clinical attachment loss ≥3 mm in >30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included.
Receives: Diagnostic Test: Before non-surgical periodontal treatment; Procedure: non-surgical periodontal treatment; Diagnostic Test: 3rd month after non-surgical periodontal treatment
smoking periodontitis (SP)participants who reported smoking >10 cigarettes per day for >5 years with clinical attachment loss ≥3 mm in >30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included.
Receives: Diagnostic Test: Before non-surgical periodontal treatment; Procedure: non-surgical periodontal treatment; Diagnostic Test: 3rd month after non-surgical periodontal treatment
non-smoking periodontal health (HC)participants who reported never smoking and periodontal healthy.
Receives: Diagnostic Test: Before non-surgical periodontal treatment
smoking periodontal health (HCS)participants who reported smoking >10 cigarettes per day and periodontal healthy.
Receives: Diagnostic Test: Before non-surgical periodontal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-treatment clinical and laboratory evaluation

    Comparison of clinical measurements and IL-18, IL-1beta, TNF-alpha, IL-10, TGF-beta, NLRP3, SIRT-1, lncRNA SNHG5, and MEG3 levels of the 4 groups in the study

    Measured: baseline

  2. Comparison of clinical measurements and laboratory measurements at 3 months post-treatment

    Comparison of clinical measurements and IL-18, IL-1beta, TNF-alpha, IL-10, TGF-beta, NLRP3, SIRT-1, lncRNA SNHG5, and MEG3 levels of periodontitis groups (NSP and SP) at the 3rd month after treatment

    Measured: 3rd month after NSPT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2024
  2. Study start25 Jun 2024
  3. Primary completion15 Dec 2025
  4. Study completion15 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06351722
Sponsor's protocol ID
smokingnlrp3inflasome
Status last verified
Aug 2026
First submitted
2 Apr 2024
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis, Adult, run by Necmettin Erbakan 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 4 inclusion and 6 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 6 Aug 2026. 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?

Pre-treatment clinical and laboratory evaluation (time frame: baseline). 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 6 Aug 2026.

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