Surgical Treatment of Periimplantitis in Patients With Risk Factors: Heavy Smokers, Type 2 Diabetic and Chronic Periodontitis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Radiographic Bone height Gain
研究概览
简要总结
This study evaluates clinical and radiographic parameters among riks factor groups in patients with periimplantitis. This study will also treat and evaluate the patients response before and after surgical treatment.
详细描述
Periimplantitis (PI) is an inflammatory process that results in tissue attachment bone loss around the implant. Periodontal disease, smoke habit and type 2diabetes mellitus have been recognized as potential risk factor indicators that might lead to complications establishment and progression around dental implants. PI treatment predictability has been shown limited and influenced by factors not totally clarified. The aim of this study is to evaluate the reparative response after PI surgical treatment at clinical and radiographic levelsin risk factors patients: type 2 diabetes mellitus, smokers and chronic periodontal disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Surgeon will not be aware of group being treated. Analyses of the data and statistics will not show explain what group has originated the data. Groups will be identified as A, B, C or D.
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
- •Implants diagnosed with peri-implantitis with boné defects; Probing depth ≥ 4mm; Positive Bleeding on Probing and Suppuration score; Radiographic Bone Loss ≥ 3mm; Generalized Chronic Periodontitis (Armitage, 1999); Heavy Smokers (> 10 cigarets per day); Type 2 Diabetes Mellitus tipo 2 (ADA, 2005) with HbA1c between 6.5% and 7.5%
排除标准
- •Complete Edentulism; Mucosal disease; Alcohol abuse; Systemic disease except type 2 Diabetes Mellitus, that might interfere in periimplantitis progression; Medication intake: anticoagulants, antineoplasics, contraceptives, bisphosphonates and antidepressives; Medication intake in the last 6 months: antibiotics; Medication intake in the last 3 months: antiinflammatories; Aggressive Periodontitis and Anaphylactic shock history; Periodontal treatment in the last 6 months before the baseline; Periodontal Pockets > 7mm; Light Smokers (< 10 cigarets/day); Implant Mobility.
研究组 & 干预措施
Smokers with Periimplantitis group
Heavy smokers patients with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
干预措施: Non-Surgical treatment (Procedure)
Smokers with Periimplantitis group
Heavy smokers patients with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
干预措施: Surgical Treatment (Procedure)
Type 2 Diabetes with Periimplantitis group
Patients diagnosed with Type 2 Diabetes with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
干预措施: Non-Surgical treatment (Procedure)
Type 2 Diabetes with Periimplantitis group
Patients diagnosed with Type 2 Diabetes with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
干预措施: Surgical Treatment (Procedure)
Chronic Periodontitis with Periimplantitis group
Patients diagnosed with Chronic Periodontitis and periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
干预措施: Non-Surgical treatment (Procedure)
Chronic Periodontitis with Periimplantitis group
Patients diagnosed with Chronic Periodontitis and periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
干预措施: Surgical Treatment (Procedure)
Control with Periimplantitis group
Systemically healthy patients with periimplantitis will be included in this group. Patients will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
干预措施: Non-Surgical treatment (Procedure)
Control with Periimplantitis group
Systemically healthy patients with periimplantitis will be included in this group. Patients will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
干预措施: Surgical Treatment (Procedure)
结局指标
主要结局
Radiographic Bone height Gain
时间窗: 3 months
Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment
次要结局
- Periimplant Pocket probing depth(3 months)
研究者
Luiz Antonio Pugliesi Alves de Lima
Associate Professor
University of Sao Paulo