Mechanisms of Acute Inflammation Following Periodontal Treatment

NCT05178563 | Not Yet Recruiting DMC

• 1 other identifier: IRAS Project number 279840
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary outcome -Flow-mediated dilatation (an ultra-sound scan) of the brachial artery- at 24 hours between study groups to see changes in vessel wall elasticity. Vessel Wall Elasticity (Vascular dysfunction) will be observed in the population of periodontitis patients who will undergo IPT with or without photodynamic therapy, using Flow mediated dilatation (FMD) which is an ultra-sound scan of brachial artery (before and after treatment). FMD measurements will be done to assess the % change in vessel wall diameter.

  24 hours post op

Secondary Outcomes (11)

• FMD at different time points following treatment between study groups.

  0, 1, 3, 7 and 180 days following treatment.

• Pulse wave velocity (PWV) at different time points following treatment between study groups.

  0, 1, 3, 7 and 180 days following treatment.

• Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.

  0, 1, 3, 7 and 180 days following treatment.

• Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.

  0, 1, 3, 7 and 180 days following treatment.

• Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.

  0, 1, 3, 7 and 180 days following treatment.

Study Arms (2)

IPT+PDT

EXPERIMENTAL

The experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT).

Procedure: IPT+PDT

; IPT+Placebo

SHAM COMPARATOR

This experimental arm consist of performing IPT in randomly assigning patients to receive sham use of photodynamic therapy(PDT).

Procedure: IPT+Placebo

Interventions

IPT+PDT PROCEDURE

The experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT).

IPT+PDT

IPT+Placebo PROCEDURE

IPT+Placebo

; IPT+Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/Female subject must be 18 years of age or over.
• Affected by periodontitis, with at least 20 sites with PPD\>4mm and have at least 20 teeth (excluding wisdom teeth).
• Have voluntarily signed the informed consent.

You may not qualify if:

• Presence of any systemic diseases (e.g., diabetes mellitus or cardiovascular, kidney, liver or lung disease).
• Pregnant or breastfeeding.
• Regular use of analgesic or antibiotics within 1 month before entering the study.
• Have untreated gross carious lesions and/or insufficient restorations.
• Allergic to any ingredient in the products provided within the trial as determined by the dental/medical professional monitoring the study.
• Concurrent participation in other clinical studies.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Eastman Dental Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Inflammation; Periodontal Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study is a double blind, CONSORT-based randomized, controlled clinical trial comparing the use of local use of photodynamic therapy (PDT) pretreatment on systemic inflammation, vascular dysfunction and patient discomfort following a single session of non surgical periodontal therapy (IPT) vs. IPT alone.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: January 5, 2022
• Study Start: September 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)