Crestal Versus Lateral Sinus Lift: One-year Results From a Within-patient Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Prosthesis failure
研究概览
简要总结
The aim of this randomised controlled trial (RCT) of split-mouth design was to compare patient preference and effectiveness of two different techniques for lifting the maxillary sinus: the crestal approach versus the lateral window approach.
详细描述
Each patient having bilateral edentulism in posterior maxillae was randomised to receive one partial fixed prosthesis supported by one to three implants placed either with a crestal or with lateral window sinus lift procedure.
Eligibility criteria for participants
Only healed implant sites were considered (at least 3 months after tooth extraction). The vertical bone height at the implant sites to be included had to be between 2 to 6 mm and bone thickness at least 6 mm as measured on cone-bean computed tomography (CBCT) scans.
Patients were not admitted in the study if any of the following exclusion criteria was present:
general contraindications to implant surgery subjected to irradiation in the head and neck area immunosuppressed or immunocompromised treated or under treatment with intravenous amino-bisphosphonates poor oral hygiene and motivation untreated periodontal disease uncontrolled diabetes pregnant or lactating substance abusers psychiatric problems unrealistic expectations lack of opposite occluding dentition/prosthesis in the area intended for implant placement acute or chronic infection/inflammation in the area intended for sinus augmentation/implant placement referred only for implant placement who cannot be rehabilitated and followed at the treatment centre unable to attend a 5-year post-loading follow-up. Smokers were included and patients were categorised into three groups according to what declare: i) non-smokers; ìì) moderate smokers, if smoking up to 10 cigarettes/day; iii) heavy smokers if smoking more than 10 cigarettes/day.
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
Where possible, outcomes assessor was blinded.
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
- •Partially edentulous patient
- •Bilateral edentulism in posterior maxillae (premolars and molars)
- •18 years or older
- •Able to understand and sign an informed consent.
- •At least 3 months after tooth extraction
- •Vertical bone height at the implant sites between 2 to 6 mm
- •Bone thickness at least 6 mm as measured on CBCT scan
排除标准
- •general contraindications to implant surgery
- •subjected to irradiation in the head and neck area
- •immunosuppressed or immunocompromised
- •treated or under treatment with intravenous amino-bisphosphonates
- •poor oral hygiene and motivation
- •untreated periodontal disease
- •uncontrolled diabetes
- •pregnant or lactating
- •substance abusers
- •psychiatric problems
- •unrealistic expectations
- •lack of opposite occluding dentition/prosthesis
- •acute or chronic infection/inflammation
- •augmentation/implant placement
- •referred only for implant placement
研究组 & 干预措施
Crestal sinus lift using iRasie implant
Device: iRaise Sinus Lift implant (Maxillent, Herzliya, Israel). Procedure: crestal sinus lift augmentation.
We tested crestal versus lateral approach to the sinus. Crestal approach is made by a novel device (iRaise, implant system). Lateral approach is made conventionally with gold standard procedure (lateral approach).
The iRaise Sinus Lift implant is made of Titanium-6 Aluminum-4 Vanadium alloy, have a surface treated with grit blasting using an apatitic calcium phosphate media, followed by acid etching, and have an internal hexagon connection. Implants have an internal l-shape channel to allow saline and graft passage.
This implants system is made to perform crestal sinus lift procedure at the same time of the implant placement using the same device. After implant site preparation and initial implant placement, the hydraulic system is connected to the implant to allow the injection of saline and then graft the material. Then, the implant, is inserted for its full length.
干预措施: Maxillary sinus augmentation (Procedure)
Lateral sinus lift
Conventional procedure.
Lateral approach to the sinus was made following the conventional procedure.
A window on the lateral wall of the sinus is performed according to a conventional surgical lateral approach to the sinus cavity. Graft materials is filled inside the sinus cavity. Finally, iSure implants [Maxillent] are placed, and flap is sutured.
干预措施: Maxillary sinus augmentation (Procedure)
结局指标
主要结局
Prosthesis failure
时间窗: Up to 5 years
Planned prosthesis which could not be placed due to implant failure(s), loss of the prosthesis secondary to implant failure(s) or a prosthesis that had to be remade for any reasons.
Patient's preference (questionnaire)
时间窗: Assessed 1 week and 1 month after surgery
Answers: 1) the side treated with the crestal technique, 2) the side treated with the lateral technique, 3) none, both treatments were equally good, 4) none, both treatments were equally bad.
Implant failure
时间窗: Up to 5 years
Implant mobility, removal of stable implants dictated by progressive marginal bone loss or infection, and implants fracture or any other mechanical complications rendering the implant unusable. The stability of each individual implant was measured with the removed prosthesis at abutment connection, at delivery definitive prostheses and at 1 year after loading, by tightening the implant abutment screws with a torque of 20 Ncm or by assessing the stability of individual crowns using the handles of two metallic instruments.
Complications
时间窗: Up to 5 years
Any technical and biological complications
次要结局
- Marginal bone loss(1 year after loading)
- Time (minutes)(The time in minutes of the surgical procedure, from the incision of the gingiva to the placement of the last stitch)
研究者
Marco Tallarico
Lecturer
Hospital San Pietro Fatebenefratelli