"Influence Of Crestal Versus Subcrestal Implant Placement Levels On Peri-Implant Health And Radiographic Bone Changes Around Short Implants: A Randomized Controlled Clinical Trial."
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Radiographic Peri-implant Crestal Bone Level Changes
研究概览
简要总结
Dental implants are widely used to replace missing teeth and restore oral function and aesthetics. One of the key factors affecting the long-term success of dental implants is the stability of the bone surrounding the implant, particularly the crestal bone around the implant neck. Implant insertion depth relative to the alveolar crest may influence peri-implant tissue health and marginal bone remodeling.
This randomized controlled clinical trial aims to evaluate the influence of implant placement depth on peri-implant health and radiographic bone changes around short dental implants placed using guided surgical protocol. All implants will be placed using the Bicon Implant System following computer-guided implant planning and surgical guide fabrication to ensure precise implant positioning.
Participants requiring implant therapy will be randomly allocated into two groups. In the test group, implants will be placed 2 mm below the crestal bone level (subcrestal placement). In the control group, implants will be placed at the crestal bone level (crestal placement). Implant placement will be performed using guided implant surgery to standardize surgical positioning and minimize variability in implant angulation and depth.
Clinical parameters related to peri-implant health, including Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index and Probing Depth during follow-up visits at 3, 6 and 12 months. In addition, standardized radiographic examinations will be performed to measure peri-implant Crestal bone level changes at 12 months.
The primary objective of this study is to determine whether subcrestal implant placement (2 mm below the bone crest) results in improved preservation of peri-implant crestal bone compared with crestal implant placement. Secondary outcomes will include assessment of peri-implant soft tissue health and overall implant stability.
The findings of this study may help clarify the optimal implant insertion depth for short implants placed using guided surgery and may contribute to improving long-term implant success and peri-implant tissue stability.
详细描述
Dental implants have become a predictable and widely accepted treatment modality for replacing missing teeth and restoring oral function, aesthetics, and patient quality of life. Long-term implant success is highly dependent on the preservation of peri-implant hard and soft tissues, particularly the stability of the crestal bone surrounding the implant neck. Early marginal bone remodeling following implant placement is considered a physiological process; however, excessive bone loss may compromise implant stability, prosthetic outcomes, and long-term implant survival.
Several factors have been suggested to influence peri-implant crestal bone remodeling, including implant design, implant-abutment connection, surgical technique, loading protocol, soft tissue thickness, and implant placement depth relative to the alveolar crest. Implant insertion depth has gained increasing interest because it may influence the establishment of peri-implant biologic width, soft tissue adaptation, and the position of the implant-abutment interface relative to the crestal bone. Subcrestal implant placement has been proposed as a potential strategy to improve marginal bone stability and optimize soft tissue emergence profile; however, evidence regarding its clinical benefits compared with crestal implant placement remains inconclusive.
Peri-implant health is typically assessed through a combination of clinical and radiographic parameters. Clinical parameters such as probing depth, plaque accumulation, bleeding on probing, and soft tissue condition provide important information regarding peri-implant tissue stability and inflammation. Radiographic evaluation remains essential for detecting marginal bone changes, which are considered a key diagnostic criterion for peri-implant disease progression and long-term implant success.
9. Periodontology 2000 - 2024 -…
The present randomized controlled clinical trial aims to evaluate the influence of implant placement depth on peri-implant health and radiographic crestal bone changes around short dental implants placed using a guided surgical protocol. The study will utilize the Bicon Implant System and a computer-guided implant placement workflow to ensure standardized implant positioning and minimize surgical variability. Digital implant planning will be performed using cone-beam computed tomography (CBCT) and virtual implant planning software. A surgical guide will be fabricated to allow accurate and reproducible implant placement according to the planned position.
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)
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
- •Adults aged 18 years or older requiring dental implant therapy for replacement of a missing tooth in the posterior maxilla or mandible.
- •Presence of sufficient bone volume to receive a short dental implant without the need for bone augmentation procedures.
- •Patients in good general health or with controlled systemic conditions that do not contraindicate implant surgery.
- •oral hygiene, defined as a plaque score ≤25%.
- •Presence of healthy or treated periodontal tissues prior to implant placement.
- •Patients willing and able to return for follow-up visits at 3, 6, and 12 months.
- •Patients who provide written informed consent to participate in the study.
排除标准
- •Patients with uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders).
- •History of radiotherapy in the head and neck region.
- •Patients currently receiving bisphosphonate therapy or other medications affecting bone metabolism.
- •Active periodontal disease or untreated oral infections.
- •Heavy smokers (≥10 cigarettes per day).
- •Presence of parafunctional habits such as severe bruxism or clenching.
- •Patients requiring simultaneous bone grafting or sinus augmentation at the implant site.
- •Pregnant or lactating women.
- •Patients unable or unwilling to comply with the study protocol or follow-up schedule.
研究组 & 干预措施
Subcrestal Implant Placement (2 mm Subcrestal)
Participants in this group will receive short dental implants placed 2 mm below the crestal bone level (subcrestal placement) using a fully guided implant surgery protocol. Implant placement will be performed using the Bicon Implant System following computer-guided implant planning and surgical guide fabrication to ensure standardized implant positioning and insertion depth. Clinical parameters of peri-implant health including Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index, and Probing Depth will be evaluated at 3, 6, and 12 months. Radiographic evaluation of peri-implant crestal bone level changes will be performed at 12 months.
干预措施: Subcrestal Dental Implant Placement (Procedure)
Crestal Implant Placement
Participants in this group will receive short dental implants placed at the crestal bone level (crestal placement) using a fully guided implant surgery protocol. Implant placement will be performed using the Bicon Implant System with computer-guided implant planning and surgical guide fabrication to standardize implant positioning and insertion depth. Clinical parameters including Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index, and Probing Depth will be evaluated at 3, 6, and 12 months, and radiographic assessment of peri-implant crestal bone level changes will be performed at 12 months.
干预措施: Crestal Dental Implant Placement (Procedure)
结局指标
主要结局
Radiographic Peri-implant Crestal Bone Level Changes
时间窗: 12 months after implant restoration
Radiographic evaluation of peri-implant crestal bone level changes around short dental implants placed at crestal and 2-mm subcrestal levels. Cone-beam computed tomography (CBCT) scans obtained at baseline and at follow-up will be digitally superimposed using image analysis software to ensure standardized comparison. Reference lines will be established based on the implant long axis and fixed anatomical landmarks to measure vertical and horizontal bone level changes around the implant. The distance from the implant reference point to the first bone-to-implant contact will be measured on the buccal, lingual, mesial, and distal aspects. These measurements will be used to quantify peri-implant crestal bone remodeling and to compare bone level changes between the two study groups.
次要结局
- Modified Plaque Index(at 3, 6 and 12 months following implant restoration)
- Implant Mucosal Index(3, 6 and 12 months after implant restoration)
- Peri-implant Mucosal Tissue Index(3, 6, and 12 months after implant restoration)
- Peri-implant Probing Depth(3, 6, and 12 months after implant restoration)