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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
Mechanical debridement of tooth surfaces using hand and ultrasonic instruments
2g Amoxicillin given 1 hour prior to instrumentation
Laser applied at base of gingival pockets prior to mechanical debridement.
air flow-based mechanical debridement with erythritol powder
Department of Periodontology, Dental School of Athens
Athens, Greece
RECRUITINGChange 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
Time frame: Baseline-7 days after the last periodontal session
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
Time frame: Baseline-7 days after the last periodontal session
Presence and load of bacteremia
culture, PCR, 16S rRNA sequencing
Time frame: Baseline-15 minutes after the last periodontal session
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.
Time frame: Baseline-8 weeks after the last periodontal session
Salivary CRP correlation with serum CRP
saliva CRP levels will be assessed and compared to serum
Time frame: Baseline-7 days after the last periodontal session
Changes in serum Tumor Necrosis Factor a (TNF-a) levels
For changes in TNF-a levels, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
Time frame: Baseline-7 days after the last periodontal session
Changes in Serum amyloid A (SAA) levels
For changes in SAA levels, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
Time frame: Baseline-7 days after the last periodontal session
Changes in Serum cystatin c levels
For changes in serum cystatin c levels, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
Time frame: Baseline-7 days after the last periodontal session
Changes in Matrix metalloproteinase-8 (MMP-8) levels
For changes in MMP-8 levels, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
Time frame: Baseline-7 days after the last periodontal session
Changes in serum D-dimers levels
For changes in serum D-dimers levels, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
Time frame: Baseline-7 days after the last periodontal session
Changes in serum Lipopolysaccharide (LPS) levels
For changes in serum LPS levels, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
Time frame: Baseline-7 days after the last periodontal session
Changes in mean Pocket Depth (PD)
PD 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. PD would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Time frame: Baseline-8 weeks after the last periodontal session
Changes in mean Gingival Recession (GR)
GR 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. GR would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Time frame: Baseline-8 weeks after the last periodontal session
Changes in Full-Mouth Plaque Score (FMPS)
FMPS 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. FMPS would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Time frame: Baseline-8 weeks after the last periodontal session
Changes in Full-Mouth Bleeding Score (FMBS)
FMBS 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. FMBS would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Time frame: Baseline-8 weeks after the last periodontal session
Changes in simplified gingival index (s-GI)
s-GI 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. s-GI would be recorded at four sites per tooth. Third molars would be excluded from the measurements.
Time frame: Baseline-8 weeks after the last periodontal session
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