Surgical Protocol for Peri-implantitis in Vertical Defect in Absence of Keratinised Tissue Using Chemical Decontamination With Chlorexidine and a CTG: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Bleeding on probing changes
研究概览
简要总结
Peri-implant diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%.
Based on the available data in literature, the surgical therapy for peri-implantitis is effective in disease resolution. Surgical access to peri-implant lesions facilitates the removal of all granulation tissue from the defect area as well as debridement and decontamination of the exposed implant surface defect area.
Different techniques have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.
详细描述
Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around implant surface characterized by bleeding on probing, probing depth and eventually bone loss; if not successfully treated they may lead to implant loss. Based on the available parameters that have been reported in literature non surgical therapy doesn't seem to be effective on peri-implantitis.
Therefore it is recommended to consider advanced therapies such as surgical interventions when non surgical peri-implant therapy fails to achieve significant improvements in clinical parameters. Numerous approaches have been used for implant surface decontamination during per-implant surgery, including mechanical, chemical and laser treatments. Conventional mechanical means don't seem to be effective on peri-implant diseases. In addition, the rough implant surface is a retentive factor for bacterial colonization and therefore makes implant surface difficult to debride. Another problem in maintaining implant health concerns the presence or absence of keratinised tissue around implant: if present, it seams to help the patient to maintain an optimal level of oral hygiene around implant and therefore the implant survival itself.
The aim of the present randomized controlled clinical trial is to assess the influence of keratinised tissue around implant in improving clinical parameters. In particular, implant surface will be decontaminated mechanically with titanium curettes and chemically using chlorhexidine; after this the bone defect will be filled with bio-materlal and a CTG around tissue implant will be randomized.
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
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
- •PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
- •PPD ≥6 and bone loss ≥3 (not compared to crestal bone levels at the time of placement of the reconstruction)
- •single tooth and bridgework restorations without overhangs no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment)
- •treated chronic periodontitis and proper periodontal maintenance care FMPS < 20%
- •non-smoker or light smoking status in smokers (<10 cigarettes per day) implant function time ≥ 1 year.
排除标准
- •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 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
结局指标
主要结局
Bleeding on probing changes
时间窗: baseline, 3, 6 and 12 months after treatment
changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing
次要结局
- mucosal recession changes(baseline, 3, 6 and 12 months after treatment)
- probing pocket depth changes(baseline, 3, 6 and 12 months after treatment)
- clinical attachment level changes(baseline, 3, 6 and 12 months after treatment)
- bone level changes(baseline, 3, 6 and 12 months after treatment)
研究者
Marco Clementini
Principal Investigator
Università Vita-Salute San Raffaele