Evaluation of the Systemic Burden of Non-surgical Periodontal Therapy: A Randomized Clinical Trial on Five Different Treatment Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in serum high-sensitivity C-reactive protein (hs-CRP) levels
研究概览
简要总结
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:
- bacteremia
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Full-Mouth SRP
oral hygiene instructions and full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.
干预措施: Scaling and Root Planing (Procedure)
SRP + Antibiotics
oral hygiene instructions and full mouth scaling and root planing in 24 hours along with antibiotic prophylaxis. Clinical re-evaluation in 8 weeks.
干预措施: Scaling and Root Planing (Procedure)
SRP + Antibiotics
oral hygiene instructions and full mouth scaling and root planing in 24 hours along with antibiotic prophylaxis. Clinical re-evaluation in 8 weeks.
干预措施: antibiotic prophylaxis (Drug)
SRP + 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.
干预措施: Scaling and Root Planing (Procedure)
SRP + 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.
干预措施: 810nm Diode Laser (Device)
SRP + 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.
干预措施: Scaling and Root Planing (Procedure)
SRP + 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.
干预措施: Air Polishing (Procedure)
Quadrant SRP (Control)
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.
干预措施: Scaling and Root Planing (Procedure)
结局指标
主要结局
Change in serum high-sensitivity C-reactive protein (hs-CRP) levels
时间窗: 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
次要结局
- Changes in serum Interleukin 6 (IL-6)(Baseline-7 days after the last periodontal session)
- Presence and load of bacteremia(Baseline-15 minutes after the last periodontal session)
- Changes in mean Clinical Attachment Level (CAL)(Baseline-8 weeks after the last periodontal session)
- Salivary CRP correlation with serum CRP(Baseline-7 days after the last periodontal session)
- Changes in serum Tumor Necrosis Factor a (TNF-a) levels(Baseline-7 days after the last periodontal session)
- Changes in Serum amyloid A (SAA) levels(Baseline-7 days after the last periodontal session)
- Changes in Serum cystatin c levels(Baseline-7 days after the last periodontal session)
- Changes in Matrix metalloproteinase-8 (MMP-8) levels(Baseline-7 days after the last periodontal session)
- Changes in serum D-dimers levels(Baseline-7 days after the last periodontal session)
- Changes in serum Lipopolysaccharide (LPS) levels(Baseline-7 days after the last periodontal session)
- Changes in mean Pocket Depth (PD)(Baseline-8 weeks after the last periodontal session)
- Changes in mean Gingival Recession (GR)(Baseline-8 weeks after the last periodontal session)
- Changes in Full-Mouth Plaque Score (FMPS)(Baseline-8 weeks after the last periodontal session)
- Changes in Full-Mouth Bleeding Score (FMBS)(Baseline-8 weeks after the last periodontal session)
- Changes in simplified gingival index (s-GI)(Baseline-8 weeks after the last periodontal session)
研究者
Evangelia Zampa
Principal investigator - DDS, MSc
National and Kapodistrian University of Athens
