种植体植入深度对短种植体周围骨变化的影响
"短种植体种植水平对种植体周围健康及影像学骨变化的影响：一项随机对照临床试验。"
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.
研究概览
地位
详细说明
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.
Eligible participants requiring implant therapy will be randomly assigned to one of two treatment 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). All implants will be placed using a guided implant surgery protocol to standardize implant angulation, position, and insertion depth.
Following implant placement, patients will undergo routine postoperative care and follow-up visits. Clinical parameters related to peri-implant health will be evaluated at 3, 6, and 12 months following implant placement. These clinical parameters will include:
Modified Plaque Index
Implant Mucosal Index
Peri-implant Mucosal Tissue Index
Probing Depth
These indices are commonly used to monitor peri-implant tissue conditions and detect early signs of inflammation or disease progression. Clinical probing and soft tissue evaluation provide essential diagnostic information regarding peri-implant mucosal health and tissue stability.
9. Periodontology 2000 - 2024 -…
Radiographic assessment will be performed using standardized periapical radiographs to evaluate peri-implant marginal bone levels. Radiographic measurements of crestal bone level changes will be performed at baseline and at 12 months after implant placement. The distance between the implant reference point and the first bone-to-implant contact will be measured to determine peri-implant marginal bone remodeling.
The primary outcome of the study is the evaluation of radiographic peri-implant crestal bone level changes after 12 months in implants placed at crestal and subcrestal levels.
Secondary outcomes include the assessment of peri-implant soft tissue health, including plaque accumulation, mucosal inflammation, and probing depth changes over the follow-up period.
This study aims to determine whether subcrestal implant placement (2 mm below the alveolar crest) provides improved preservation of peri-implant crestal bone and peri-implant tissue health compared with crestal implant placement when using a standardized guided implant surgery protocol.
The findings of this clinical trial may contribute to improving clinical decision-making regarding optimal implant insertion depth and may provide evidence-based guidance for implant placement protocols using short implants and guided surgical techniques.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ajman Emirate
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Ajman、Ajman Emirate、阿拉伯联合酋长国、4184
- Gulf Medical University
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
Placement of short dental implants using a computer-guided surgical protocol with the implant positioned 2 mm below the alveolar crest (subcrestal placement). Implant placement will be performed using a surgical guide following digital implant planning to standardize implant position, angulation, and insertion depth. Short implants from the Bicon Implant System will be used. Postoperative evaluation will include clinical assessment of peri-implant health parameters (Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index, and Probing Depth) at 3, 6, and 12 months, and radiographic assessment of peri-implant crestal bone level changes at 12 months. |
|
有源比较器：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. |
Placement of short dental implants using a computer-guided surgical protocol with the implant positioned at the level of the alveolar crest (crestal placement). Implant placement will be performed using a surgical guide following digital implant planning to standardize implant position, angulation, and insertion depth. Short implants from the Bicon Implant System will be used. Clinical evaluation of peri-implant health parameters (Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index, and Probing Depth) will be performed at 3, 6, and 12 months, and radiographic evaluation of peri-implant crestal bone level changes will be conducted at 12 months. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Radiographic Peri-implant Crestal Bone Level Changes
大体时间：12 months after implant restoration
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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. |
12 months after implant restoration
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Modified Plaque Index
大体时间：at 3, 6 and 12 months following implant restoration
|
Assessment of plaque accumulation around dental implants using the Modified Plaque Index (mPI). The index will be recorded at four sites around each implant (mesial, distal, buccal, and lingual) to evaluate plaque accumulation on implant components. The scoring system will be as follows: Score 0: No plaque detected. Score 1: Plaque detected only by running a probe across the smooth marginal surface of the implant. Score 2: Plaque visible to the naked eye. Score 3: Abundance of soft plaque accumulation |
at 3, 6 and 12 months following implant restoration
|
|
Implant Mucosal Index
大体时间：3, 6 and 12 months after implant restoration
|
Evaluation of peri-implant mucosal inflammation using the Implant Mucosal Index (IMI). After drying the peri-implant area, a periodontal probe will be gently moved (≤1 mm) in an encircling motion around the implant sulcus with light pressure directed toward the soft tissue. The presence and severity of bleeding or suppuration will be recorded after a few seconds. The scoring system is as follows: Score 0: No bleeding. Score 1: Minimal, single-point bleeding. Score 2: Moderate, multiple-point bleeding. Score 3: Profuse, multiple-point bleeding. Score 4: Suppuration. |
3, 6 and 12 months after implant restoration
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Peri-implant Mucosal Tissue Index
大体时间：3, 6, and 12 months after implant restoration
|
Assessment of peri-implant soft tissue conditions using the Peri-implant Mucosal Tissue Index (MTI). This index evaluates the appearance, consistency, and texture of the peri-implant mucosa and is used to monitor peri-implant tissue health during follow-up. The peri-implant mucosa will be clinically examined around each implant, and the following scoring system will be used: Score 0: Normal mucosa. Score 1: Mild inflammation with slight color change and edema. Score 2: Moderate inflammation with redness, edema, and glazing. Score 3: Severe inflammation with redness, edema, and ulceration. |
3, 6, and 12 months after implant restoration
|
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Peri-implant Probing Depth
大体时间：3, 6, and 12 months after implant restoration
|
Measurement of probing depth around dental implants as The distance recorded in mm from the mucosal margin to the base of the pocket using a periodontal probe at six sites. This parameter will be used to evaluate peri-implant soft tissue health and detect potential peri-implant tissue changes. |
3, 6, and 12 months after implant restoration
|
合作者和调查者
调查人员
- 研究主任：Mohamed Atef Sayed, Ph.D.、Gulf Medical University
- 首席研究员：Marwa Mahayni, M.D.S、Gulf Medical University
- 学习椅：Hesham Marei, Ph.D.、Gulf Medical University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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