About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Periodontitis stage III or IV
Non-smokers or light smokers (<10 cigarettes/day)
No NSAIDs in regular basis or antibiotics 3 months before
No previous periodontal treatment 12 months before
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Scaling and Root Planing
Procedure/SurgeryMechanical debridement of tooth surfaces using hand and ultrasonic instruments
antibiotic prophylaxis
Drug2g Amoxicillin given 1 hour prior to instrumentation
810nm Diode Laser
DeviceLaser applied at base of gingival pockets prior to mechanical debridement.
Air Polishing
Procedure/Surgeryair flow-based mechanical debridement with erythritol powder
Treatment groups
Trial outcomes
Primary outcomes
Change in serum high-sensitivity C-reactive protein (hs-CRP) levels
For hs-CRP, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
Secondary outcomes
Changes in serum Interleukin 6 (IL-6)
For IL-6, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
Presence and load of bacteremia
culture, PCR, 16S rRNA sequencing
Changes in mean Clinical Attachment Level (CAL)
CAL would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session. All clinical measurements would be taken using a manual probe. CAL would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Salivary CRP correlation with serum CRP
saliva CRP levels will be assessed and compared to serum
Sponsors and contacts
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