Survival Rate of Dental Implants Placed in Sinus Lift Performed With Two Different Grafts
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Prosthesis failure
研究概览
简要总结
Previous in a randomized way, it will be performance 12 bilateral sinus lift with autologous bone in one side and the in other with xenograft material. After 6 mouths we will place 1 to 3 implants in each side and analyse the survival rate and possibles differences related to; prosthesis failure; biological and prosthetic complications; peri-implant marginal bone level changes.
详细描述
The study will be performance in 12 patients submitted to a bilateral sinus lift procedure.
Six months after the bilateral sinus lifting performed in a randomly way, using as graft materials (100% of autologous bone graft or 100% of xenograft), will be placed 1 to 3 implants in each maxillary sinus.
Wait more six months to expose the implant. At the end of 13 months after implant placement it should be in charge.
Implant placement (6 months after sinus lift procedure):
- Both sides should be treated during the same session.
- Patients will receive 2g Amoxicillin one hour before the procedure. Patients allergic to penicillin will be given Clindamycin 600 mg 1 hour before implant placement procedure.
- Patients will rinse for 1 minute prior to flap elevation with 0.12% chlorhexidine mouthwash.
- After delivery of local anaesthesia, incision and flap elevation, the recommendation of the various implant manufacturers will be followed for placing 1 to 3 implants 9-11 mm long per posterior upper (premolar-molar areas) below the maxillary sinus and a histological sample for each side will be collected.
- The neck of the implants will be placed flush to the bone and implants will be submerged under the soft tissues and flaps will be sutured.
- Baseline intraoral radiographs of the study implants have to be taken.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Seal envelops, codification of the side and patient and independent blind assessors
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any partially edentulous patient having bilateral edentulism in the posterior maxillae (premolars and/or molars) with a similar degree of bone resorption requiring one to three implants at each side, being 18 years or older, and able to sign an informed consent. For all the potentially included patients preoperative CBCT (cone beam computed tomography) or CT scans and OPGs (orthopantomograph)must be obtained and attached to the files. The vertical bone height below the maxillary sinus at the implant sites must be of 1-5 mm and bone thickness at least 6 mm measured on CBCT (cone-beam computed tomography)or CT scans. Smokers will be included and patients will be grouped into: 1) non smokers; 2) light smokers ≤ 10 cigarettes/day; 3) heavy smokers ≥ 11 cigarettes/day, according to what they declare.
排除标准
- •General contraindications to implant surgery.
- •Patients irradiated in the head and neck area.
- •Immunosuppressed or immunocompromised patients.
- •Patients treated or under treatment with intravenous amino-bisphosphonates.
- •Patients with untreated periodontitis.
- •Patients with poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Pregnancy or nursing.
- •Substance abuser.
- •Psychiatric problems or unrealistic expectations.
- •Lack of opposite occluding dentition in the area intended for implant placement.
- •Patients with an acute or chronic sinusitis.
- •Patients participating in other trials, if the present protocol cannot be properly adhered too.
- •Patients referred only for implant placement.
- •Patient unable to be followed for 5 years after loading.
研究组 & 干预措施
survival rate autologous bone
dental implant placement in the previous sinus lift side with autologous bone; dental implant placement in the previous sinus lift side with xenograft material side;
干预措施: Survival rate dental implant (OsseoSpeed™) (Device)
survival rate axenograft material
dental implant placement in the previous sinus lift side with xenograft material side;
干预措施: Survival rate dental implant (OsseoSpeed™) (Device)
结局指标
主要结局
Prosthesis failure
时间窗: up to 5 years of loading
when prosthesis placement will not be possible due to implant failure or secondary to implant failure.
radiological analysis
时间窗: 6 mounths
Comparation of the bone gain in a radiological analysis (initial and at 6 months)
Prosthetic complications
时间窗: up to 5 years
Prosthetic complications (number and type).
Histological and histomorphological analysis
时间窗: 6 mounths
Histological and histomorphological analysis of the bone graft
Clinical evaluation - questionary
时间窗: 6 mounths
questionary about patient preference treatment
Implant failure
时间窗: up to 5 years of loading
implant mobility assessed manually with the removed prosthesis and/or any infection dictating implant removal. Assessments will be done at delivery of the provisional and definitive prostheses, 1, 3 and 5 years of loading by tightening the abutment screws with the removed prostheses.
Peri-implant marginal bone level changes
时间窗: up to 5 years
Peri-implant marginal bone level changes assessed on periapical radiographs taken with the paralleling technique at implant placement, at initial prosthetic loading, 1 and 5 years follow-up in function. The distance between marginal bone level and implant/abutment junction, approximated to half mm, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at patients level and then at group level.
Biological complications
时间窗: up to 5 years
Biological complications (number and type). Particular attention will be used to assess possible sinus pathologies.
次要结局
未报告次要终点