Evaluation of the Systemic Burden of Non-surgical Periodontal Therapy: A Randomized Clinical Trial on Five Different Treatment Protocols
- Conditions
- Periodontitis
- Interventions
- Procedure: Scaling and Root PlaningDrug: antibiotic prophylaxisDevice: 810nm Diode LaserProcedure: Air Polishing
- Registration Number
- NCT07077122
- Lead Sponsor
- National and Kapodistrian University of Athens
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full-Mouth SRP Scaling and Root Planing oral hygiene instructions and full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. SRP + Antibiotics 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. SRP + Antibiotics antibiotic prophylaxis 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 Scaling and Root Planing 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 + Laser 810nm Diode Laser 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 Scaling and Root Planing oral hygiene instructions and air polishing following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. SRP + Air Polishing Air Polishing 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) Scaling and Root Planing 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 sessionPresence 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 sessionChanges 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 sessionChanges 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 sessionChanges 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 sessionChanges 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 sessionChanges 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 sessionChanges 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.
Trial Locations
- Locations (1)
Department of Periodontology, Dental School of Athens
🇬🇷Athens, Greece
Department of Periodontology, Dental School of Athens🇬🇷Athens, GreeceProf. Madianos P., DDS, PhDContact00302107461181pmadian@dent.uoa.gr