Actively Recruiting

Phase Not Applicable
All Genders
NCT07077122

Evaluation of the Systemic Burden of Non-surgical Periodontal Therapy: A Randomized Clinical Trial on Five Different Treatment Protocols

Led by National and Kapodistrian University of Athens · Updated on 2025-09-04

75

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Periodontitis is a chronic inflammatory disease of the periodontal tissues leading to the destruction of the tooth supporting structures. Despite the fact that periodontal bacteria are etiological agents, host susceptibility related to the inflammatory response to plaque bacteria is the main determinant of the development of periodontitis. Non-surgical periodontal therapy (NSPT) represents the base of any therapeutic approach. Its main component is the removal of bacterial deposits, i.e. soft biofilm or mineralized calculus, from the tooth surface via mechanical debridement. It is well established that patients suffering from periodontitis present with a low-grade systemic inflammatory state when compared to healthy subjects. Increased concentrations of inflammatory biomarkers in systemic circulation, such as, C-reactive protein (CRP) and interleukin (IL)-6, have already been reported. A significant amount of evidence derived from epidemiological as well as experimental studies has implicated periodontitis as a putative risk factor for a number of systemic diseases, such as, cardiovascular diseases, diabetes and respiratory diseases having systemic low-grade inflammation as their underlying pathogenic mechanism. Furthermore, several intervention studies provide evidence that periodontal treatment may improve systemic inflammatory markers and potentially reduce the risk for cardio-metabolic diseases. However, periodontal therapy may pose a transient, short-term health hazard immediately after instrumentation of the root surface presumably due to the spill of bacteria and their products in the systemic circulation and the subsequent acute inflammatory response. Positive bacteremia in NSPT ranges from 13% to 80.9% after mechanical debridement depending primarily on the periodontal status of the patient, but also on the study design and the microbiological methodology. Finally, an important aspect concerning NSPT is method and duration of delivery. NSPT may be carried out with either hand instruments, power driven instruments, such as, ultrasonic and sonic or a "blended approach" using both. Besides these instruments, the adjunctive use of lasers or/and air powder technology has been proposed. Regarding duration, treatment may be staged over several visits with a quadrant approach, or with a full-mouth debridement approach, also referred to as an intensive treatment approach, which delivers complete debridement within 24 hours. The aim of this clinical trial is to assess the immediate systemic burden of five different treatment protocols for the NSPT on: 1. bacteremia 2. serum inflammatory responses. Additionally, saliva CRP levels will be assessed and compared to serum. Moreover, the effectiveness of the treatment protocols on clinical periodontal parameters will be assessed.

CONDITIONS

Official Title

Evaluation of the Systemic Burden of Non-surgical Periodontal Therapy: A Randomized Clinical Trial on Five Different Treatment Protocols

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with periodontitis stage III or IV
  • Non-smoker or light smoker (fewer than 10 cigarettes per day)
  • No regular use of NSAIDs or antibiotics within the last 3 months
  • No periodontal treatment in the past 12 months
  • No other acute or chronic infections
  • No systemic diseases or medications affecting inflammatory markers
  • Not pregnant or breastfeeding
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Regular use of NSAIDs or antibiotics within the last 3 months
  • Previous periodontal treatment within the last 12 months
  • Presence of other acute or chronic infections
  • Systemic diseases or medications that influence inflammatory marker levels
  • Pregnancy or lactation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Periodontology, Dental School of Athens

Athens, Greece

Actively Recruiting

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Research Team

Z

Zampa Evangelia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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