Mechanisms of Acute Inflammation Following Periodontal Treatment
NCT ID: NCT05178563
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-09-01
2026-12-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IPT+PDT
The experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT).
IPT+PDT
The experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT).
; IPT+Placebo
This experimental arm consist of performing IPT in randomly assigning patients to receive sham use of photodynamic therapy(PDT).
IPT+Placebo
IPT+Placebo
Interventions
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IPT+PDT
The experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT).
IPT+Placebo
IPT+Placebo
Eligibility Criteria
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Inclusion Criteria
2. Affected by periodontitis, with at least 20 sites with PPD\>4mm and have at least 20 teeth (excluding wisdom teeth).
3. Have voluntarily signed the informed consent.
Exclusion Criteria
2. Pregnant or breastfeeding.
3. Regular use of analgesic or antibiotics within 1 month before entering the study.
4. Have untreated gross carious lesions and/or insufficient restorations.
5. Allergic to any ingredient in the products provided within the trial as determined by the dental/medical professional monitoring the study.
6. Concurrent participation in other clinical studies.
18 Years
ALL
Yes
Sponsors
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University College, London
OTHER
Responsible Party
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Locations
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Eastman Dental Hospital
London, , United Kingdom
Countries
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Facility Contacts
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Francesco D'Aiuto, PhD
Role: primary
Other Identifiers
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IRAS Project number 279840
Identifier Type: -
Identifier Source: org_study_id