Efficacy of Photodynamic Therapy in the Non-Surgical Treatment of Peri-Implantitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Probing Depth
研究概览
简要总结
Peri-implantitis is a growing public health problem that can lead to several complications and sequelae, with a serious impact on the health and quality of life of patients and a high cost for healthcare systems.
Bacterial plaque that accumulates around dental implants leads to peri-implant tissue inflammation that ultimately can result in the loss of the implant, significant bone destruction and infection that can reach other regions. Successful implant decontamination is necessary to preserve the implant and several strategies have been suggested for this purpose, however, there is still no fully effective treatment modality and failures and recurrence are relatively frequent.
To better understand this problem and develop more effective treatment strategies, investigators will first conduct an epidemiological study to understand the factors associated with the development of this pathology. Although there is data at an international level, the incidence of this problem in Portugal has not yet been properly studied. Later investigators will conduct a randomized clinical trial to evaluate the 6-week clinical outcomes of patients treated with a photodynamic therapy as an adjuvant versus the use of conventional titanium implant curettes for implant surface decontamination in the non-surgical treatment. Sixty patients/implants with peri-implantitis and within the established criteria, will undergo non-surgical treatment with one of the two protocols being studied. Various clinical and radiographic parameters will be evaluated, such as probing depth, insertion loss, recession, bleeding on probing, suppuration, peri-implant crevicular fluid volume, alveolar bone loss and peri-implantitis microbiome will be evaluated before surgery and 6 weeks after surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years of age;
- •patients with one or more implants diagnosed with peri-implantitis rehabilitated for at least one year;
- •PI and GI < 25%.
排除标准
- •smoking patients;
- •patients with uncontrolled periodontitis;
- •systemic diseases that influence the study (diabetes);
- •inadequate prosthetic rehabilitation that cannot be modified or that prevents access for physical decontamination;
- •implants rehabilitated with cemented crowns;
- •pregnant and lactating women;
- •previous surgical intervention at the same site;
- •therapy with non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics or immunosuppressants in the last 3 months;
- •patients previously undergoing chemotherapy or radiotherapy;
- •PI and IG > 25%;
- •uncooperative patients.
研究组 & 干预措施
Control Group
Mechanical debridment with titanium curettes and ultrasounds
干预措施: Mechanical debridment with titanium curettes and ultrasounds (Procedure)
Study Group
Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)
干预措施: Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy) (Procedure)
结局指标
主要结局
Probing Depth
时间窗: From enrollment to the end of treatment at 3 months
Measuring in milimeters the distance from the gingival margin to the base of a sulcus or peri-implant pocket, using a periodontal probe.
次要结局
- Clinical attachment level(From enrollment to the end of treatment at 3 months.)
- Bleeding on Probing(From enrollment to the end of treatment at 3 months.)
- Suppuration(From enrollment to the end of treatment at 3 months.)
- Radiographic bone level(From enrollment to the end of treatment at 3 months.)
- Microbiology outcome(From enrollment to the end of treatment at 3 months.)