Periodontitis
Conditions
Keywords
periodontitis, inflammatory markers, non-surgical periodontal therapy, bacteremia
Brief summary
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.
Interventions
PROCEDUREScaling and Root Planing
Mechanical debridement of tooth surfaces using hand and ultrasonic instruments
DRUGantibiotic prophylaxis
2g Amoxicillin given 1 hour prior to instrumentation
DEVICE810nm Diode Laser
Laser applied at base of gingival pockets prior to mechanical debridement.
PROCEDUREAir Polishing
air flow-based mechanical debridement with erythritol powder
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 * No presence of other acute or chronic infections * No systemic disease or medication known to affect the serum level of inflammatory markers (cyclooxygenase inhibitors, platelet aggregation inhibitors, lipid lowering agents, â-adrenoreceptor antagonists, angiotensin converting enzyme inhibitors, antidiabetic agents, estrogen-based medications, medication for autoimmune disease, magnesium or vitamin E supplements) * No pregnancy or lactation * Written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum high-sensitivity C-reactive protein (hs-CRP) levels | Baseline-7 days after the last periodontal session | For hs-CRP, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence and load of bacteremia | Baseline-15 minutes after the last periodontal session | culture, PCR, 16S rRNA sequencing |
| Changes in mean Clinical Attachment Level (CAL) | Baseline-8 weeks after the last periodontal session | 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 | Baseline-7 days after the last periodontal session | saliva CRP levels will be assessed and compared to serum |
| Changes in serum Tumor Necrosis Factor a (TNF-a) levels | Baseline-7 days after the last periodontal session | 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 |
| Changes in Serum amyloid A (SAA) levels | Baseline-7 days after the last periodontal session | 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 |
| Changes in Serum cystatin c levels | Baseline-7 days after the last periodontal session | 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 |
| Changes in Matrix metalloproteinase-8 (MMP-8) levels | Baseline-7 days after the last periodontal session | 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 |
| Changes in serum Interleukin 6 (IL-6) | Baseline-7 days after the last periodontal session | For IL-6, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session |
| Changes in serum Lipopolysaccharide (LPS) levels | Baseline-7 days after the last periodontal session | 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 |
| Changes in mean Pocket Depth (PD) | Baseline-8 weeks after the last periodontal session | 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. |
| Changes in mean Gingival Recession (GR) | Baseline-8 weeks after the last periodontal session | 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. |
| Changes in Full-Mouth Plaque Score (FMPS) | Baseline-8 weeks after the last periodontal session | 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. |
| Changes in Full-Mouth Bleeding Score (FMBS) | Baseline-8 weeks after the last periodontal session | 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. |
| Changes in simplified gingival index (s-GI) | Baseline-8 weeks after the last periodontal session | 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. |
| Changes in serum D-dimers levels | Baseline-7 days after the last periodontal session | 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 |
Countries
Greece
Contacts
Primary ContactZampa Evangelia
Outcome results
None listed