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Not Yet RecruitingNCT05178563

Mechanisms of Acute Inflammation Following Periodontal Treatment

Mechanisms of Acute Inflammation Following Periodontal Treatment (STUDENT STUDY)

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University College, London · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases. Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterized the time-course of a single session of non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs. Photodynamic therapy (PDT) helps kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated.

Detailed description

Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases. Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterised the time-course of a single session of intense non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs. The efficacy of periodontal therapy is directly related to the ability of treatment to control the infection sustained by gum bacteria. Several chemical agents, such as antiseptic/bacteriostatic liquids, gels or membranes have been added to the conventional periodontal therapy with the view of improving clinical outcomes. The latest evidence advocates the use of lasers to eliminate bacteria in the periodontal pockets. Photodynamic therapy (PDT) is the process of eradication of target cells by reactive oxygen compound produced after activation of a photo-sensitiser by light of appropriate wavelength. Dental lasers used for PDT can be high-level lasers, low-level laser, and diode lasers. PDT used in dentistry for microbial killing, usually involves the use of low-intensity diode laser irradiation along with photosensitises as a means of arresting the anti-microbial activity. Researchers and clinicians don't fully understand the mechanism underlying the local and systemic pathways involved in the role of periodontal/oral inflammation on systemic health and diseases Based on the evidence that PDT could kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated. The investigators hypothesized that using PDT before NSPT would result in less local and systemic inflammation/ED Understanding the mechanisms of ED in humans could lead to new beneficial and/or preventive strategies for cardio vascular disease.

Conditions

Interventions

TypeNameDescription
PROCEDUREIPT+PDTThe experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT).
PROCEDUREIPT+PlaceboIPT+Placebo

Timeline

Start date
2024-09-01
Primary completion
2025-12-30
Completion
2026-12-31
First posted
2022-01-05
Last updated
2023-11-29

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05178563. Inclusion in this directory is not an endorsement.