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

NCT06351722 | Not Yet Recruiting

• 1 other identifier: smokingnlrp3inflasome
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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), 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?

Conditions

Periodontitis, Adult

Keywords

periodontitis; smoking; NLRP3 inflammasome; SIRT1; non-coding RNA

Outcome Measures

Primary Outcomes (2)

• 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

  baseline

• 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

  3rd month after NSPT

Study Arms (4)

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.

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.

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.

Diagnostic Test: Before non-surgical periodontal treatment

smoking periodontal health (HCS)

participants who reported smoking \>10 cigarettes per day and periodontal healthy.

Diagnostic Test: Before non-surgical periodontal treatment

Interventions

Before non-surgical periodontal treatment DIAGNOSTIC_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-smoking periodontitis (NSP); non-smoking periodontal health (HC); smoking periodontal health (HCS); smoking periodontitis (SP)

non-surgical periodontal treatment PROCEDURE

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.

Non-smoking periodontitis (NSP); smoking periodontitis (SP)

3rd month after non-surgical periodontal treatment DIAGNOSTIC_TEST

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

Non-smoking periodontitis (NSP); smoking periodontitis (SP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Serum, white cells and saliva

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: March 15, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04