Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Absence of medical related osteonecrosis of the jaw (MRONJ)
研究概览
简要总结
Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose > 4 years.
详细描述
The hypothesis of the present study is that dental implant therapy using submerged healing is feasible and predictable in patients receiving high, adjuvant or low dose AR for more than 4 years, as documented by clinical and radiographic signs of osseointegration after 3-4 months, sufficient implant stability for abutment connection, and implant survival rates comparable to those of healthy individuals after one year of prosthetic loading.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cancer or osteoporosis, treated with antiresorptive treatment.
- •The patients should have sufficient compliance, this includes willingness to have the planned assessments
- •The patient should have an expected life span at enrollment of at least 2 years.
- •The local bone quality and quantity should be sufficient for implant insertion without bone augmentation and is classified according to the classification by Cawood & Howell 1988.
排除标准
- •> 10 cigarettes daily
- •HbA1c > 53 mmol/mol
- •Poor oral hygiene
- •Poor general condition: ECOG score 3 or
- •Poor prognosis: Expected survival <2 year is an exclusion cause.
- •Presence of metastases of the liver brain.
- •Poor local jaw bone quality acc. to Cawood classification stage 3 or
- •Unwillingness to comply with the planned assessments and recordings
结局指标
主要结局
Absence of medical related osteonecrosis of the jaw (MRONJ)
时间窗: 30 months
Defined as no exposed bone, no fistula, no radiologic sign of MRONJ
Dental implant survival
时间窗: 30 months
Defined as presence of the implant 2 years after loading of the final prosthetics
Dental Implant success
时间窗: 30 months
Defined as less marginal bone loss than 1.5 mm the first year, and 0.2 mm per year thereafter at time of assessment
次要结局
- EORTC QLQ-H&N 35(30 months)
- Oral Health Impact Profile(30 months)
研究者
Sanne Werner Moeller Andersen
Oral and Maxillofacial Surgeon
Copenhagen University Hospital at Herlev