Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Implant failure
研究概览
简要总结
The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.
详细描述
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Implants have same macro design.
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 subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.
排除标准
- •Patients unable to commit to 5 years follow-up.
- •General contraindications to implant surgery.
- •Less then 4 mm of keratinised gingiva crestally (at the implant sites).
- •Immune-suppressed/compromised patients.
- •Patients irradiated in the head and/or neck.
- •Uncontrolled diabetes.
- •Pregnancy or lactation.
- •Untreated periodontal disease.
- •Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
- •Addiction to alcohol or drugs.
- •Psychiatric problems and/or unrealistic expectations.
- •Patients with an acute infection or suppuration in the site intended for implant placement.
- •Patients needing any form of tissue augmentation at implant placement.
- •Immediate post-extractive implants (implants can be placed after a 3-month healing period).
- •Patients treated or under treatment with intravenous amino-bisphosphonates.
- •Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
- •Patients participating in other studies, if the present protocol could not be fully adhered to.
研究组 & 干预措施
SA Implants
Dental implant with sandblasted and Acid-etched (SA) surface
干预措施: Placement of dental implants (surgical procedure) (Procedure)
SOI Implants
Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent
干预措施: Placement of dental implants (surgical procedure) (Procedure)
结局指标
主要结局
Implant failure
时间窗: From implant placement up to 60 months after loading
Implant removal for any reason will be considered an implant failure.
Crown failure
时间窗: From crown delivery up to 60 months
Crown replacement for any reason will be considered a crown failure.
Complications
时间窗: From implant placement up to 60 months after loading
Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.
次要结局
- Peri-implant marginal bone level (MBL) changes(From implant placement up to 60 months after loading)
- Probing pocket depth (PPD)(From crown delivery up to 60 months)
- Bleeding on probing (BOP)(From crown delivery up to 60 months)
- plaque index (PI)(From implant placement up to 60 months after loading)
- Implant stability quotient(The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement.)
- Pink Esthetic Score(From crown delivery up to 60 months)
研究者
Marco Tallarico
Coordinator
Osstem AIC