An interventional study of Scaling and Root Planing and antibiotic prophylaxis in Periodontitis, sponsored by National and Kapodistrian University of Athens. Recruiting at 1 site in Greece. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Treatment
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:
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 75 is above the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
oral hygiene instructions and full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.
Procedure: Scaling and Root Planing
oral hygiene instructions and full mouth scaling and root planing in 24 hours along with antibiotic prophylaxis. Clinical re-evaluation in 8 weeks.
Procedure: Scaling and Root Planing · Drug: antibiotic prophylaxis
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.
Procedure: Scaling and Root Planing · Device: 810nm Diode Laser
oral hygiene instructions and air polishing following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.
Procedure: Scaling and Root Planing · Procedure: Air Polishing
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.
Procedure: Scaling and Root Planing
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
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
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
Plan to share: Yes — IPD used in the results publication
Time frame: After publication of the main study results.
Access criteria: Data will be available upon reasonable request to qualified researchers for academic purposes.
Started Aug 2025 (actual). Primary completion is estimated for Jul 2027, 22 months after the start.
Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 22 months is above that.
Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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