Alveolar Ridge Preservation (ARP) in the Posterior Maxilla: A Clinical and Economic Evaluation of ARP After the Extraction of Maxillary Molars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient reported outcomes (PROMs) and perception by using of Oral Health Impact Profile-14 (OHIP-14)
研究概览
简要总结
Dental implants are a fixed replacement solution with reported long-term survival rates between 94-98% over 20-40 years. In order to ensure successful implant therapy, adequate bone and soft tissue as well as correct 3D positioning of the implant are required. Upon extraction of a tooth, socket width can decrease by up to 60% within six months post-extraction, with a 11-22% vertical reduction. Additionally, sinus pneumatization occurs post-extraction as the maxillary sinus expands into the empty socket due to disuse atrophy and intra-sinus air pressure, as explained by Wolff's law. This further reduces residual bone height (RBH), often resulting in posterior maxillary sites requiring supplemental procedures to prevent bone loss or to augment the bone height at the time of implant placement. However, if the bone height and width dimensions are sufficient before and after extraction - in that, even with the aforementioned loss in width and height percentages in the latter, a standard implant may still be placed in the surrounding bone, one can argue that grafting may not be necessarily done at the time of extraction. Rather, it can be tailored to the patients' needs; thus potentially reducing overall post-operative discomfort and pain.
详细描述
Bone grafting is a standard of care procedure often done several times during the course of therapy to ensure adequate surrounding bone to the implant. Alveolar ridge preservation (ARP) has emerged as an evidence-based and clinically validated approach for extraction site management, aiming to mitigate the dimensional bone and soft tissue loss that routinely follows tooth extraction. This is especially relevant in the posterior maxilla, where natural healing is often accompanied by significant reductions in both horizontal and vertical ridge dimensions. Oftentimes clinicians are faced with challenges intrasurgical that may lead to compromising the prosthetically driven implant position. Through thorough surgical planning prior to extraction, the investigators may be able to personalize bone grafting and surgical approaches in implant therapy, reduce the number of times the investigators graft while still achieving an ideal implant position, and improve the overall experience patients have. Careful preoperative analysis must be conducted to help guide clinicians in making these intraoperative decisions.
To address these limitations, this study leverages an interdisciplinary collaboration between the Departments of Periodontics and Prosthodontics at Virginia Commonwealth University (VCU). This team offers:
- Coordinated surgical and prosthetic planning,
- Integration of digital workflows for predictable implant positioning,
- Comprehensive follow-up and patient retention in a controlled academic environment.
This multidisciplinary model ensures biologic ridge preservation, prosthetically guided treatment, and cost-effective, real-world application of ARP strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No Masking. Subjects either receiving Immediate Grafting vs. Delayed Grafting.
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
- •Intact or <5mm dehiscence buccally and palatally
- •Initial residual bone height (RBH) of at least 6 mm. 3-A minimum distance of 1 mm between root apices and sinus membrane.
排除标准
- •Medically compromised
- •heavy smokers
- •young (<18 yrs.) or those refusing treatment are excluded.
研究组 & 干预措施
Immediate Grafting
Subject will receive immediate grafting using Ossix Plus (FDA approved resorbable cross-linked collagen membrane) and Ossix bone graft (FDA approved).
All materials utilized in this study are commercially available, FDA-approved, used in standard of care procedures and commercially available by Dentsply Sirona. They will be used in accordance with the manufacturer's labeling and instructions. These materials are currently used for ARP and grafting in the VCU clinics.
干预措施: Ossix mineralized grafting immediately at extraction (Other)
Delayed Grafting
Grafting will be performed after extraction and at the time of implant placement (T3, as referred to in the section on study timelines) using Ossix Agile® (FDA approved- resorbable collagen membrane), and Ossix bone graft (FDA approved).
All materials utilized in this study are commercially available, FDA-approved, used in standard of care procedures and commercially available by Dentsply Sirona. They will be used in accordance with the manufacturer's labeling and instructions. These materials are currently used for ARP and grafting in the VCU clinics.
干预措施: Delayed grafting at implant placement (Other)
结局指标
主要结局
Patient reported outcomes (PROMs) and perception by using of Oral Health Impact Profile-14 (OHIP-14)
时间窗: Post-Implant: 2 week, 6 month and 1 year visits
The OHIP-14 is a 14-question survey that measures how oral health problems affect a person's quality of life, assessing aspects like pain, discomfort, and limitations in daily activities across seven domains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap). A 5-point Likert scale is used for responses, and scores are summed (0-56). Higher scores indicate worse oral health impact.
次要结局
- To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone thickness.(Post-Implant: 2 week, 6 month and 1 year visits)
- To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating soft tissue vertical thickness.(Post-Implant: 2 week, 6 month and 1 year visits)
- To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating soft tissue horizontal thicknesses.(Post-Implant: 2 week, 6 month and 1 year visits)
- To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating sinus pneumatization.(Post-Implant: 2 week, 6 month and 1 year visits)
- To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone height.(Post-Implant: 2 week, 6 month and 1 year visits)
- To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone width.(Post-Implant: 2 week, 6 month and 1 year visits)
- To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating marginal bone levels.(Post-Implant: 2 week, 6 month and 1 year visits)