Long-Term Bone Dimensional Changes Following Flapless Immediate Implant Placement With or Without Bone Grafting: A 5 Years Follow up of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Labial bone formed labial to the implant
研究概览
简要总结
Nowadays, achieving long-term hard tissue stability is the definitive goal of a successful immediate implant placement and has become the optimal challenge for clinicians over the past few decades. It is wellestablished that the dimensional changes and remodeling of the alveolar ridge represent a physiologic sequela of tooth extraction and is inevitable especially the labial bone wall. This creates an unfavorable labio-palatal discrepancy and produces the "fixture-socket gap" around the coronal portion of the implant, known as the labial gap especially in sockets with thin bone.Although this gap has the potential to repair spontaneously in some cases, still previous studies reported that this gap cannot be completely filled without using a regenerative material. It has been claimed that buccal/labial gap augmentation contributes to the final esthetic success of the dental implant, where the regenerative material acts as a scaffold to maintain the blood clot, promote bone formation, compensate for the postextraction socket remodeling and maintain the buccal bone thickness and thereby preventing the buccal contour collapse. Nevertheless, this would add an additional cost and prolong the surgical procedure. Meanwhile, there is a controversy in the existing literature regarding the actual benefit of using bone grafts in the buccal gap. Previous systematic reviews concluded that there is not sufficient evidence to prove that immediate implant placement with grafting the labial gap, would comprise an additional benefit in preventing alveolar ridge reduction and contour collapse. Furthermore, previous controlled clinical trials reported that evidence for this additional treatment is still unclear.
详细描述
Patients who completed the initial trial and received a single immediate implant in a fresh extraction socket would be invited for reassessment at 5 years after implant placement. The intervention group would comprise patients treated with flapless immediate implant placement combined with grafting of the peri-implant gap using the same bone-substitute material and protocol applied in the original study, while the control group would comprise patients treated with flapless immediate implant placement without bone grafting. The primary outcome would be the change in peri-implant marginal bone level and three-dimensional alveolar ridge dimensions, assessed by standardized periapical radiographs and, where ethically and clinically justified, limited-field cone-beam computed tomography, compared with baseline and the earlier follow-up measurements. Secondary outcomes would include implant survival and success, peri-implant probing depth, bleeding on probing, plaque accumulation, mucosal recession, width of keratinized mucosa, facial soft-tissue profile, biological complications, prosthetic complications, patient satisfaction, and esthetic outcomes. Assessments should be performed by calibrated, blinded examiners using standardized imaging and clinical protocols. The study would analyze all eligible participants according to their original randomized allocation, report reasons for loss to follow-up, and compare the long-term dimensional stability and clinical performance of grafted versus nongrafted sites. The principal hypothesis would be that bone grafting may reduce long-term horizontal ridge resorption and improve preservation of the facial contour without adversely affecting implant survival or peri-implant health over the 5-year observation period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>20 years) with nonrestorable maxillary teeth in the esthetic zone, thick gingival phenotype, intact but thin labial plate of bone extending 7 mm (≤1 mm) and intact palatal bone extending at least 6 mm apically, sufficient apical bone to attain implant primary stability (a minimum of 35 N cm insertion torque) and labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5 mm.
排除标准
- •Smokers, pregnant women, patients with systemic disease, patients with parafunctional habits such as bruxism or clenching, infected socket, periapical pathosis and history of radiotherapy or chemotherapy within the past 2 years.
研究组 & 干预措施
IIP + Bone graft + CHA
For patients assigned to receive a graft, demineralized bovine bone graft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland) was placed in the gap labial to the implant to the level of the implant platform.
干预措施: IIP+Bone graft + CHA (Procedure)
IIP + CHA only
A tapered screw-vent bone level implant (Zimmer implant TSV, IN, USA) was inserted into the extraction socket in a flapless manner, engaging mm of the sound intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which was set to be at least 35 N cm to allow nonfunctional immediate loading. The implant platform was located 1.5 mm subcrestal or equicrestal to the labial bone and the implant diameter was selected to leave a labial gap of at least 1.5 mm. Following implant placement, patients received an immediate anatomical customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva (Filtek™ Supreme Ultra Flowable Restorative, 3M Corporate Headquarters, MN, USA). It was then screwed to the implant
干预措施: IIP +CHA only (Procedure)
结局指标
主要结局
Labial bone formed labial to the implant
时间窗: 5 years follow up
Measure using the CBCT, the amount of bone formed labial to the implant
次要结局
未报告次要终点