The goal of this observational study is to distinguish the infectious, healing, and regeneration-related characteristics of two types of gingival granulation tissues, namely infra-osseous and supra-osseous granulation tissues, in people with severe periodontitis (gum disease). Researchers aim to denote if these tissues may play role in healing after periodontal treatment. Researchers will also compare smokers and non-smokers to see if smoking disrupts the healing potential or infectious properties of granulation tissue. Participants will provide gingival fluid (before) and granulation tissue samples (at the time of) periodontal surgery. The main questions this study aims to answer are: 1. Do infra- and supra-osseous granulation tissues have different healing potential and infectious properties? 2. How do these tissues differ in people who smoke compared to people who do not smoke?
Both genders.
Systemically healthy.
Both smokers (smoking at least 10 cigarettes a day or electronic cigarettes daily or quit less than 5 years ago) and non-smokers (never smoked, smoke no more than once a month or quit at least 5 years ago).
Patients aged 18 years and over.
Systemic diseases that may affect study results (uncontrolled type 2 diabetes mellitus (HBA1c level of >7%); recent (less than 6 months ago) myocardial infarction or stroke; blood coagulation disorders; recent use of antibiotics (less than 6 months).
Use of medications that may affect study results (anti-osteoporotic drugs, statins, corticosteroids, calcium channel blockers, cyclosporine A, antiepileptic drugs, antipsychotic medication or antidepressants, chemotherapy and/or radiotherapy (active or history)).
Current pregnancy and/or breastfeeding.
Patients who have received any form of systemic antibiotics in the last six months prior to the start of the study.
The study will be formed of two study groups: 1. Non-smoking Stage III-IV Grade B-C periodontitis patients with at least one infra-osseous approximal bone defect (with ≥3 mm infrabony component) at premolar-molar region (n=23). 2. Smoking Stage III-IV Grade B-C periodontitis patients with at least one infra-osseous approximal bone defect (with ≥3 mm infrabony component) at premolar-molar region (n=23). The sample size for the present cross-sectional study was determined using R (package pwr, function pwr.t.test with type=paired). The effect size, Cohen's D = 0.941, was derived from the Interleukin-10 (IL-10) to total protein ratio. The total sample size was calculated to be 46 patients in two equally sized dependent groups, with a power of 99% (beta = 0.01) and an alpha of 0.05. All patients will be recruited from among those enrolled in Riga Stradins University Institute of Stomatology Periodontology Department maintenance treatment program.
Case-only
Cross-sectional
Not listed
Comparison of pro-healing/regenerative markers and microbial composition/virulence profiles in infra-osseous and supra-osseous granulation tissues between smokers and non-smokers with Stage III-IV Grade B-C periodontitis.
Regenerative markers: IL-1β, IL-6, TNF-α (pro-inflammatory), IL-4, IL-10 (anti-inflammatory), CCL-2/MCP-1, CCL-8/MCP-2, CXCL9/MIG, CCL-3/MIP-1α (macrophage-activation related chemokines), osteoprotegerin, RANKL, osteocalcin, osteopontin (bone-remodeling markers). Microbial outcomes: presence, abundance, and virulence characteristics of bacteria in infra- and supra-osseous granulation tissue.
Differences in regenerative and microbial markers between infra-osseous and supra-osseous granulation tissues within the non-smoking group.
Effect of smoking on selected regenerative and virulence markers in infra-osseous granulation tissue.
Correlation between tissue biochemical/microbial markers and clinical periodontal parameters.
Clinical periodontal parameters, such as probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BoP%), and plaque index (PI%) will be analyzed.
Click on the lead sponsor to view all of their trials.
Riga Stradins University
Lead sponsor
University of Turku
Collaborator
