Clinical trial NCT05178563: Mechanisms of Acute Inflammation Following Periodontal Treatment
Official title: Mechanisms of Acute Inflammation Following Periodontal Treatment (STUDENT STUDY)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammation
Periodontal Diseases
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Male/Female subject must be 18 years of age or over.
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:

1. Presence of any systemic diseases (e.g., diabetes mellitus or cardiovascular, kidney, liver or lung disease).
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.

Primary outcomes:
measure: The primary objective is to investigate the efficacy and safety of pre-treatment with photodynamic therapy on systemic vascular dysfunction (assessed via FMD) following a single session of non-surgical periodontal therapy (IPT) vs. IPT alone.
timeFrame: 24 hours post op
Secondary outcomes:
measure: FMD at different time points following treatment between study groups.
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Pulse wave velocity (PWV) at different time points following treatment between study groups.
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Evaluate the effect of PDT /IPT on markers of endothelial function
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Evaluate the effect of PDT /IPT on glycemic profile
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Evaluate the effect of PDT /IPT on oxidative profile
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Evaluate the effect of PDT/IPT on the monocyte subset, monocyte platelet aggregate (MPA) , and circulating endothelial progenitor cells (EPC).
timeFrame: 0, 1, 3, 7 and 180 days following treatment.
measure: Investigate the periodontal clinical parameters following IPT with and without the use of PDT.
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Eastman Dental Hospital
Study officials:
References: