Antimicrobial Photodynamic Therapy Mediated by Papain Gel on Peri-implantitis Lesions: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 主要终点
- Change in loss of clinical insertion
研究概览
简要总结
The elimination of pathogenic microorganisms from the muco-gingival tissue and implant pockets system is one of the main aspects for success in the treatment of peri-implantitis. The purpose of this study is to conduct a blinded and randomized clinical trial to evaluate the effectiveness of photodynamic therapy in the treatment of peri-implantitis. Twenty implants with peri-implantitis will be selected. Implants will be randomly divided into two groups (n = 10), Group 1: control - conventional treatment and Group 2: conventional treatment and antimicrobial photodynamic therapy (aPDT). aPDT will be performed after the purse removal service in sites with pockets greater than or equal to 5 mm. The photosensitizer will be PapaMblue®, which will be deposited in the peri-implant pockets, with pre-irradiation time of 1 min. Next, the laser emitting a wavelength of 660 nm, with power of 100 mW, for 2 min, radiant exposure of 30 J/cm2 and power density of 250 mW/cm2 in the buccal and mesial regions will be applied. The distribution of the data within each group will be evaluated and the variances will be checked to choose a more appropriate statistical analysis. The sample calculation is based on the literature and the significance level of 5% will be adopted.
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)
盲法说明
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe for measurements of plaque index, probing bleeding, probing depth, gingival recession and loss of clinical insertion. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT. The evaluator will not know to which group the patient belongs.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have peri-implantitis;
- •Have at least one implant with a clinical depth of probing equal to or greater than 5 mm;
- •Age range of 18 to 65 years.
排除标准
- •Smokers or ex-smokers who stopped the habit less than 12 months before the screening;
- •Have decompensated diabetes;
- •Pregnant;
- •Use antibiotics in the last 3 months12;
- •Make use of anti-inflammatories or have coagulation disorders (use of anticoagulants, presence of liver diseases, thrombocytopenia, immunosuppression);
- •In orthodontic treatment;
- •Patients who maintained a biofilm index higher than 25%.
研究组 & 干预措施
Control group
The treatment will consist of oral hygiene orientation, with brushing technique instructions and daily flossing recommendation. All patients will receive a demonstration of oral hygiene techniques. The calculus deposits on the teeth will be removed with an ultrasound equipment and curettes for root scaling and straightening13. In implants, calculus will be removed with specific curettes for use on the implant surface. Treatment will be performed in 2 to 4 sessions under local anesthesia (typically 2% mepivacaine with 1: 100,000 noradrenaline). Gracey periodontal curettes (numbers 3/4, 7/8, 11/12 and 13/14) and Mc Call for removal of the dental calculus will be used. Other biofilm-retaining factors, such as carious lesions, condemned teeth and maladaptive restorations, will be removed during these periodontal treatment sessions.
干预措施: Conventional treatment (Procedure)
aPDT group
aPDT will be performed after conventional treatment, in sites with pockets greater than or equal to 5 mm. The PapaMblue® photosensitizer with 100 μM methylene blue will be deposited in the pockets with a syringe, with the bottom of the pouch in the coronal direction, and a pre-irradiation time of 1 min will be adopted, so that the PS may stain the entire bacterial biofilm. Then, the laser emitting an wavelength of 660 nm, with power of 100 mW, will be applied. The laser will be applied to the mucosa on the oral epithelium with an optical fiber (apparatus of DMC Therapy EC, São Carlos, Brazil). Irradiation will be performed until the entire peri-implanted pouch is illuminated for 2 minutes at each point. The 6 points around the implant will be irradiated and each irradiation point will present an area of 0.4 cm2, which will result in radiant exposure of 30 J/cm2 following 2 min of irradiation per point. The irradiation will have a constant power density of 250 mW/cm2.
干预措施: Conventional treatment (Procedure)
aPDT group
aPDT will be performed after conventional treatment, in sites with pockets greater than or equal to 5 mm. The PapaMblue® photosensitizer with 100 μM methylene blue will be deposited in the pockets with a syringe, with the bottom of the pouch in the coronal direction, and a pre-irradiation time of 1 min will be adopted, so that the PS may stain the entire bacterial biofilm. Then, the laser emitting an wavelength of 660 nm, with power of 100 mW, will be applied. The laser will be applied to the mucosa on the oral epithelium with an optical fiber (apparatus of DMC Therapy EC, São Carlos, Brazil). Irradiation will be performed until the entire peri-implanted pouch is illuminated for 2 minutes at each point. The 6 points around the implant will be irradiated and each irradiation point will present an area of 0.4 cm2, which will result in radiant exposure of 30 J/cm2 following 2 min of irradiation per point. The irradiation will have a constant power density of 250 mW/cm2.
干预措施: aPDT (Radiation)
结局指标
主要结局
Change in loss of clinical insertion
时间窗: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of loss of clinical insertion. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Change in probing bleeding
时间窗: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of probing bleeding. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Change in probing depth
时间窗: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of probing depth. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Change in gingival recession
时间窗: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of gingival recession. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Change in plaque index
时间窗: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of plaque index. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
次要结局
- Microbiological examination (change in CFUs (Colony Forming Units))(Baseline and immediately after treatment.)
研究者
Renato Araujo Prates
Principal Investigator
University of Nove de Julho