Microbiological and Clinical Efficacy of Photodynamic Therapy in Combination With Non-surgical Periodontal Therapy: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Probing Pocket Depth PPD Index
研究概览
简要总结
Non-surgical periodontal therapy is a widely adopted procedure for the treatment of periodontitis, particularly in its moderate to severe stages. The approach involves the mechanical and manual debridement of subgingival biofilm and calculus through the use of ultrasonic scalers and hand curettes. This method aims to disrupt the pathogenic bacterial load within periodontal pockets and promote clinical attachment gain while reducing inflammation. However, the mechanical removal of biofilm alone may not always ensure complete bacterial eradication, especially in deep or anatomically complex sites.
To enhance bacterial disinfection and optimize clinical outcomes, adjunctive use of antimicrobial photodynamic therapy (aPDT) has been introduced. aPDT is a non-invasive technique that involves the activation of a photosensitizing agent by light at a specific wavelength, leading to the production of reactive oxygen species capable of selectively damaging microbial cells. This reaction occurs without affecting surrounding healthy tissues and has been shown to be effective against a broad spectrum of periodontal pathogens.
The synergistic effect of combining conventional non-surgical periodontal therapy with aPDT allows for a more comprehensive decontamination of periodontal pockets. In particular, aPDT contributes to the disruption of residual bacterial biofilm that may persist after mechanical instrumentation, thereby potentially improving both short- and long-term periodontal stability. In addition to its antimicrobial action, aPDT may exert a biostimulatory effect, enhancing tissue healing through increased local microcirculation and cellular activity.
This study aims to evaluate the clinical efficacy of adjunctive antimicrobial photodynamic therapy following non-surgical periodontal treatment in patients with severe periodontitis. The protocol involves initial subgingival instrumentation using ultrasonic and manual tools, followed by the application of a photosensitizer and subsequent laser activation within the periodontal pockets. The hypothesis of this study is that the addition of aPDT provides superior bacterial reduction and improved clinical outcomes compared to mechanical therapy alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 84 years;
- •Good general health status;
- •Diagnosis of severe periodontitis involving at least 30% of all teeth, with at least three non-adjacent teeth presenting three sites with probing pocket depth (PPD) greater than 4 mm in at least two quadrants, and having lost at least four teeth due to periodontitis;
- •Presence of at least 16 teeth, with a minimum of four teeth per quadrant.
排除标准
- •Pregnancy or breastfeeding;
- •Presence of decompensated systemic diseases that may compromise the outcomes of the study or the patient's health;
- •Regular use of antibiotics;
- •Regular use of anti-inflammatory drugs (NSAIDs, corticosteroids, or aspirin);
- •Use of anticoagulant medications;
- •History of systemic antibiotic therapy within six months prior to enrollment;
- •History of any periodontal therapy within six months prior to enrollment;
- •Presence of severe mental or cognitive disorders.
研究组 & 干预措施
Experimental : antimicrobial photodynamic therapy (aPDT) after non-surgical therapy
The test group received antimicrobial photodynamic therapy (aPDT) immediately after non-surgical treatment. A diode laser with a wavelength of 660 nm was used (Helbo® TheraLite Laser, Bredent, Germany). The photosensitizer (Helbo® Biofilm Marker), based on phenothiazine chloride and supplied in pre-packaged sterile syringes, was delivered into the periodontal pocket using a sterile syringe with a flat tip. The photosensitizer was left in situ for 60 seconds. Subsequently, all periodontal pocket walls were irradiated for ten seconds each (disto-lingual, lingual, mesio-lingual, mesio-buccal, buccal, disto-buccal), for a total duration of 60 seconds.
干预措施: antimicrobial photodynamic therapy (aPDT) after non-surgical therapy (Device)
No intervention: non-surgical therapy
In the control group, non-surgical periodontal therapy was performed using both mechanical and manual instrumentation with curettes and ultrasonic devices.
结局指标
主要结局
Probing Pocket Depth PPD Index
时间窗: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)
Probing depth is the distance from the gingival margin to the base of the pocket (mm)
Microbiological analysis
时间窗: T0 (Baseline), T2 (14 days after baseline), T3 (3 months after baseline)
The microbiological analysis qualitatively (yes/no) assesses the presence of six types of periodontopathogenic bacteria (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Treponema denticola, Actinomyces naeslundii) using sterile paper points inserted into the periodontal pocket prior to non-surgical periodontal therapy. For each site analyzed, two saliva samples are collected: one is placed in a test tube containing ethanol, and the other in a tube containing ammonium thioglycolate. The samples are subsequently transported to the microbiology department of the Integrated University Hospital of Verona for analysis.
次要结局
- Recession REC Index(T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline))
- Clinical attachment level CAL Index(T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline))
- Plaque Index(T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline))
- Bleeding on probing BOP Index(T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline))
研究者
Alessia Pardo
PhD
Universita di Verona