Non Surgical Protocol for Treatment of Peri-implantitis
关键词
抽象
描述
Peri-implantitis, defined as an inflammatory lesion in the surrounding peri-implant tissues with loss of supporting bone, are important disease entities as a result of their high prevalence and the lack of a standard mode of therapy. Although the current epidemiological data are limited, peri-implantitis affects 28-56% of the subjects and 12-43% of the implants.
Numerous approaches have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments. Using conventional mechanical means, eradication of pathogens on implant surfaces with threads and often with rough surface structures is difficult. Treatment models, such as debridment, effectively used to treat teeth with periodontitis, cannot be used in the same way on rough threaded implant surfaces. The implant rough surface structure also provides the bacteria with ''protected areas'', inaccessible to conventional mechanical removal.
A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy. Data have shown that treatments with Er:YAG lasers have a bactericidal effect. Er:YAG laser treatment can debride the implant surface effectively and safely. Slightly better clinical results in terms of bleeding on probing and clinical attachment level have been reported by Er:YAG laser treatment as compared with traditional non-surgical mechanical debridement with curette and chlorhexidine.
The air abrasive method for the removal of bacterial plaque on tooth surfaces has also been used in the treatment of peri-implantitis, demonstrating no relevant adverse effects. Until recently, air-polishing devices have used a slurry of water and sodium bicarbonate (NaHCO3) and pressurized air/water. A less abrasive method using an amino acid glycine has been proven to be effective in removing bacterial biofilm structures in deep periodontal pockets and safe by not causing emphysema. Moreover the use of a glycine-based powder does not seem to cause titanium implant surface changes.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical and chemical cleaning during non surgical treatment of peri-implantitis.
日期
| 最后验证: | 03/31/2019 |
| 首次提交: | 02/19/2018 |
| 提交的预估入学人数: | 02/24/2018 |
| 首次发布: | 03/01/2018 |
| 上次提交的更新: | 04/15/2019 |
| 最近更新发布: | 04/17/2019 |
| 实际学习开始日期: | 07/01/2018 |
| 预计主要完成日期: | 02/28/2021 |
| 预计完成日期: | 06/30/2021 |
状况或疾病
干预/治疗
Procedure: mechanical debridement and chemical decontamination
Procedure: Er:YAG laser
Procedure: Air Powder
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Sham Comparator: Chlorhexidine mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Chlorhexidine. | |
| Experimental: Er:YAG laser Er:YAG laser treatment will be provided on the implant surface. | Procedure: Er:YAG laser mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Chlorhexidine. Furthermore, Er:YAG laser treatment will be provided on the implant surface. |
| Active Comparator: Air Powder an Air-Powder treatment will be provided on the implant surface. | Procedure: Air Powder mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Clorhexidine. Furthermore, an Air-Powder treatment will be provided on the implant surface. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with: 1. a PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction) 2. a PPD ≥ 6 mm and bone loss ≥ 3 mm (not compared to crestal bone levels at the time of placement of the reconstruction) - single tooth and bridgework restorations without overhangings - no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment) - implant function time ≥ 1 year. Exclusion Criteria: - Patients with uncontrolled diabetes, - patients with osteoporosis or under bisphosphonate medication, - pregnant or lactating women, - patients with a history of radiotherapy to the head and neck region - patients with incapability to perform basal oral hygiene measures due to physical or mental disorders - hollow implants - implant mobility - implants at which no position could be identified where proper probing measurements could be performed; - previous surgical treatment of the peri-implantitis lesions |
结果
主要结果指标
1. Bleeding on probing changes. [baseline, 1, 3, 6 months]
次要成果指标
1. probing pocket depth changes [baseline,1, 3, 6 months]
2. mucosal recession changes [baseline, 1, 3, 6 months]
3. clinical attachment level changes [baseline, 1, 3, 6 months]
