Peri-implantitis - Regenerative Treatment With Enamel Matrix Derivative (EMD). Clinical Effects, Microbial Profiles and Molecular Mechanisms. A Randomised Controlled Pilot Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Changes in marginal bone level at dental implant
研究概览
简要总结
The purpose of the study is to evaluate if surgical treatment of peri-implantitis with enamel matrix derivative (Emdogain®, EMD) will have an additional effect on the healing outcome, changes in the peri-implant microflora and on the inflammatory response in the periimplant pocket at 12 months.
详细描述
This is a randomised controlled clinical trial. Recruiting 31 patient with periimplantitis at one or more implants in need for surgical treatment.
Randomisation to test group (EMD) with surgical treatment and additional application of enamel matrix derivative (Emdogain®) or surgical treatment alone in the control group (non-EMD).
Treatment of existing periodontitis performed before recruitment. Baseline examination including samples of microbiota and peri-implant fluid followed by surgical treatment. Access surgery to remove chronic inflammatory tissue and clean the implant surface from biofilm and implant stone with hand instrument and ultrasonic device with special tips for implants, followed by polishing the implant surface with a gauze, super floss and rinsing with saline. Allocation with a performed block randomisation at the stage of surgery, after cleaning of implant surface. Application of enamel matrix derivative (Emdogain®) or not, just before closure of flap. After surgery rinsing with chlorhexidine 0.2% twice a day in 6 weeks. No systemic antibiotic used in this study.
Supportive care program, including hygiene instructions and professional cleaning supragingival at implants and teeth at 2 weeks, 3, 6, 9 and 12 months after treatment.
Examination with measurements of pocket depth and bone levels at radiographs at baseline just before surgery and 12 months and prevalence of bleeding on probing, pus or recession as well as full mouth plaque score and full mouth bleeding score at 3, 6, 9 and 12 months.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •peri-implant angular bone loss ≥3 mm, measured at radiographs
- •deep pocket ≥5 mm combined with bleeding and/or pus
排除标准
- •individuals with uncontrolled diabetes (HbA1c > 7,0%)
- •individuals where prophylaxis of antibiotic is indicated
- •medication with prednisolon or other anti-inflammatory drug
- •medication with gingival hyperplasia known as a side effect
- •systemic antibiotic intake the last 3 months
研究组 & 干预措施
Surgery alone
access peri-implant surgery and cleaning of implant surface with saline
干预措施: Surgery alone (Device)
Surgery and Emdogain®
access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline
干预措施: Emdogain® (Device)
结局指标
主要结局
Changes in marginal bone level at dental implant
时间窗: 12 months
次要结局
- Number of sites with bleeding on probing(3,6, 9, 12 months)
- Number of sites with bacterial plaque at the implant(3,6, 9, 12 months)
- Number of sites with suppuration on probing(3,6, 9, 12 months)
- Number of sites with marginal gingival recession(3,6, 9, 12 months)
- Full mouth plaque score(3,6, 9, 12 months)
- Changes in peri-implant microflora incidence and composition(2weeks, 3, 6, 12 months)
- Changes in peri-implant pocket depth(12 months)
- Full mouth bleeding score(3,6, 9, 12 months)
研究者
Catrine Isehed
DDS, periodontist
Region Gävleborg