7 mm Versus 5 mm Diameter Immediate Post-Extractive Implants in the Molar Region: A Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Biological and biomechanical complications
研究概览
简要总结
This clinical study aims to evaluate the performance and long-term outcomes of immediate dental implants placed in molar sites after tooth extraction. Eligible patients will receive one implant and a single crown in a posterior area (first or second molar). The study will compare implant and crown success over a five-year period, tracking complications, bone changes, aesthetics, and patient satisfaction. Participants must be at least 18 years old and have sufficient bone to allow immediate implant placement. This research will provide important data on the safety and reliability of immediate implants in posterior areas.
详细描述
This multicentre randomised controlled trial aims to compare the clinical outcomes of 7 mm versus 5 mm diameter dental implants placed immediately after tooth extraction in the molar region. The goal is to assess whether wider diameter implants offer any advantages in terms of implant survival, complications, bone preservation, and patient satisfaction, when placed in fresh extraction sockets.
A total of 70 patients requiring molar tooth extraction and immediate implant placement will be enrolled across 7 centers. Each participant will receive either a 5 mm or a 7 mm diameter implant, allocated randomly. Standardised surgical and prosthetic protocols will be followed.
Follow-up visits will assess implant stability, radiographic bone changes, and clinical outcomes over time. Patient-reported outcomes and complications will also be recorded to compare the two groups. Results will be reported at 1 and 5 years after loading.
This study may help clinicians make evidence-based decisions when choosing the diameter of implants in molar regions, particularly in immediate post-extraction situations.
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
The statistician performing the data analysis is masked to the treatment allocation in order to prevent bias during statistical evaluation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •able to sign an informed consent form
- •requiring at least one immediate post-extractive implant in first and/or second molar sites
- •sufficient bone to allow placement of an immediate implant at least 7 mm in length and 7 mm in diameter
排除标准
- •general contraindications to implant surgery
- •immunosuppressed or immunocompromised
- •irradiation in the head or neck area
- •uncontrolled diabetes
- •pregnancy or lactation
- •untreated periodontitis
- •poor oral hygiene and motivation
- •addiction to alcohol or drugs
- •psychiatric disorders
- •unrealistic expectations
- •acute infection (abscess) in the site intended for implant placement
- •necessity to lift the maxillary sinus epithelium
- •unable to commit to 5-year follow-up post-loading
- •under treatment or had previous treatment with intravenous amino-bisphosphonates
- •lack of bony wall completely surrounding the future implant
- •participation in other studies interfering with present protocol.
研究组 & 干预措施
7 mm Diameter Implant
Participants receive a 7 mm diameter implant placed immediately after molar extraction.
干预措施: 7 mm Diameter Dental Implant (Device)
5 mm Diameter Implant
Participants receive a 5 mm diameter implant placed immediately after molar extraction.
干预措施: 5 mm Diameter Dental Implant (Device)
结局指标
主要结局
Biological and biomechanical complications
时间窗: From implant placement to 5 years after loading.
Biological and biomechanical complications will be recorded and reported by study group. Examples of biological complications are: fistula, peri-implantitis. Examples of biomechanical complications are fracture of the metal screws, loosening of the crown, fracture of ceramic.
Number of failed crowns (not placed or remade due to implant/prosthetic failure)
时间窗: From implant placement to 5 years after loading.
whether it will not be possible to place the crown because of implant failure or secondary to implant failure, or crown that has to be remade for any reason.
Number of failed implants (implant mobility, infection, or mechanical complications)
时间窗: From implant placement to 5 years post loading.
Implant failure is defined as implant mobility and/or any infection dictating implant removal, and or/any mechanical problems rendering the implant unusable. The stability of each individual implant will be measured by the independent and blinded outcome assessor manually with a reverse torque of 20 Ncm at abutment connection and at delivery of the definitive crown, or by assessing the stability of the crown, using the handles of two metallic instruments, at 1 and 5 years after loading.
Biological and biomechanical complications
时间窗: From implant placement to 5 years after loading.
Biological and biomechanical complications will be recorded and reported by study group. Examples of biological complications are: fistula, peri-implantitis. Examples of biomechanical complications are fracture of the metal screws, loosening of the crown, fracture of ceramic.
次要结局
- Peri-implant marginal bone level changes(From implant placement to 5 years after loading.)
- Aesthetic evaluation(From implant placement to 5 years after loading.)
- Patient satisfaction(From implant placement to 5 years after loading.)
- Peri-implant marginal bone level changes(From implant placement to 5 years after loading.)
- Aesthetic evaluation(From implant placement to 5 years after loading.)
- Patient satisfaction(From implant placement to 5 years after loading.)
研究者
Marco Esposito
Associate Professor
Marco Esposito