Health TrialsbyHealthPanel

Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

ConditionsPeriodontitisPeriodontal DiseasePeriodontal HealthSmokingInflammasomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUskudar University

About this trial

The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β) and interleukin-10 (IL-10). Furthermore, this study aims to investigate whether the salivary levels of these inflammasomes may serve as potential diagnostic biomarkers for distinguishing individuals with periodontitis from those without. In addition, the potential role of smoking in modulating the relationship between periodontal status and salivary inflammasome levels will also be explored.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

systemically healthy,

clinical diagnosis of periodontitis,

clinical diagnosis of periodontal health

Disqualifiers

history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);

nonsurgical periodontal treatment (previous 6 months);

surgical periodontal treatment (previous 12 months);

presence of <20 teeth;

Trial population

The study will consist of four groups: Group 1: healthy individuals (control (C)), Group 2: smokers with healthy periodontium (S-C), Group 3: nonsmokers with Stage III/IV periodontitis (P), Group 4: smokers with Stage III/IV periodontitis (S-P)

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Periodontal examinations

    Diagnostic test

    With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, periodontal inflammatory surface area (PISA) parameters are recorded.

  • Collection of saliva samples

    Diagnostic test

    Levels of salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β), and interleukin-10 (IL-10) will be determined using an enzyme-linked immunosorbent assay (ELISA).

Treatment groups

116 Participants
are divided into 4 treatment groups
Group A: Group 1 (C)2 interventions
Group B: Group 2 (S-C)2 interventions
Group C: Group 3 (P)2 interventions
Group D: Group 4 (S-P)2 interventions

Trial outcomes

Primary outcomes

1

Clinical attachment level (mm)

Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time. Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth. In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ. In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.

Time frame
Baseline
2

Probing pocket depth

Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.

Time frame
Baseline
3

Bleeding on probing

The number obtained by dividing the sum of the positive areas by the sum of the examined areas is multiplied by 100 and the value obtained is expressed as the percentage of bleeding at probing (BOP%).

Time frame
Baseline

Secondary outcomes

1

Plaque percentage

The presence or absence of plaque is determinant, recorded as (+) in the presence of plaque or (-) in the absence of plaque, and the percentage of the entire mouth affected by plaque is expressed as a percentage (P%).

Time frame
Baseline
2

Periodontal inflammatory surface area (PISA)

It is the calculation of the area of ulcerated periodontal pockets showing bleeding on probing based on the periodontal epithelial surface area.

Time frame
Baseline
3

Salivary interleukin-10 (IL-10) levels

Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. Il-10 levels in saliva will be measured using the enzyme-linked immunosorbent assay (ELISA) method.

Time frame
Baseline
4

Salivary interleukin-1beta (IL-1β) levels

Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. IL-1β levels in saliva will be measured using the ELISA method.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uskudar University

Lead sponsor

Source ClinicalTrials.gov
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