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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics committee | Other Identifier | Dental School of Athens, NKUA |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-Mouth SRP | Experimental | oral hygiene instructions and full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. |
|
| SRP + Antibiotics | Experimental | oral hygiene instructions and full mouth scaling and root planing in 24 hours along with antibiotic prophylaxis. Clinical re-evaluation in 8 weeks. |
|
| SRP + Laser | Experimental | oral hygiene instructions and 810nm diode laser at the base of the gingival sulcus/pocket following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. |
|
| SRP + Air Polishing | Experimental | oral hygiene instructions and air polishing following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. |
|
| Quadrant SRP (Control) | Active Comparator | Oral hygiene instructions, scaling and root planing per quadrant with an interval of 7 days per session. Clinical re-evaluation in 8 weeks after last session. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and Root Planing | Procedure | Mechanical debridement of tooth surfaces using hand and ultrasonic instruments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum high-sensitivity C-reactive protein (hs-CRP) levels | For hs-CRP, blood would be collected:
| Baseline-7 days after the last periodontal session |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum Interleukin 6 (IL-6) | For IL-6, blood would be collected:
| Baseline-7 days after the last periodontal session |
| Presence and load of bacteremia |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zampa Evangelia | Contact | 00306987027896 | elina_zampa@windowslive.com |
| Name | Affiliation | Role |
|---|---|---|
| Madianos Phoebus | Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology, Dental School of Athens | Recruiting | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32011025 | Result | Sanz M, Marco Del Castillo A, Jepsen S, Gonzalez-Juanatey JR, D'Aiuto F, Bouchard P, Chapple I, Dietrich T, Gotsman I, Graziani F, Herrera D, Loos B, Madianos P, Michel JB, Perel P, Pieske B, Shapira L, Shechter M, Tonetti M, Vlachopoulos C, Wimmer G. Periodontitis and cardiovascular diseases: Consensus report. J Clin Periodontol. 2020 Mar;47(3):268-288. doi: 10.1111/jcpe.13189. Epub 2020 Feb 3. | |
| 32383274 |
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IPD used in the results publication
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After publication of the main study results.
Data will be available upon reasonable request to qualified researchers for academic purposes.
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|
| antibiotic prophylaxis | Drug | 2g Amoxicillin given 1 hour prior to instrumentation |
|
| 810nm Diode Laser | Device | Laser applied at base of gingival pockets prior to mechanical debridement. |
|
| Air Polishing | Procedure | air flow-based mechanical debridement with erythritol powder |
|
culture, PCR, 16S rRNA sequencing |
| 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. | Baseline-8 weeks after the last periodontal session |
| Salivary CRP correlation with serum CRP | saliva CRP levels will be assessed and compared to serum | 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:
| Baseline-7 days after the last periodontal session |
| Changes in Serum amyloid A (SAA) levels | For changes in SAA levels, blood would be collected:
| 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:
| 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:
| 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:
| Baseline-7 days after the last periodontal session |
| Changes in serum Lipopolysaccharide (LPS) levels | For changes in serum LPS levels, blood would be collected:
| 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. | 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. | 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. | 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. | 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. | Baseline-8 weeks after the last periodontal session |
| Result |
| Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290. |
| 15966875 | Result | Kinane DF, Riggio MP, Walker KF, MacKenzie D, Shearer B. Bacteraemia following periodontal procedures. J Clin Periodontol. 2005 Jul;32(7):708-13. doi: 10.1111/j.1600-051X.2005.00741.x. |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| D019072 | Antibiotic Prophylaxis |
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
| D018890 | Chemoprevention |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011292 | Premedication |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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