Evaluation of the Effects of the Small Intestine Submucosa (SIS) Biological Membrane on Guided Bone Regeneration (GBR) and Early Loading of Dental Implants in the Maxillary Anterior Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Marginal bone level assessment
研究概览
简要总结
The aim of this randomized controlled trial (RCT) is to determine whether early implant loading that shortens the healing period to 6 weeks can be safely and effectively applied to implants with good initial stability in the maxillary anterior region, which undergoes simultaneous guided bone regeneration (GBR), via clinical examination, intraoral scanning, imageological diagnosis, and aesthetic scoring, and to determine the clinical effect of the small intestine submucosa (SIS) biological barrier membrane in such cases involving early loading. This study is expected to provide preliminary guidance on the timing of loading for a single maxillary anterior implant with insufficient bone volume and provide a theoretical basis for the selection of a biological barrier membrane for GBR in such patients.
详细描述
Patients were randomized into three groups at a 1:1:1 ratio, including the GBR with a Bio-Gide membrane and delayed implant loading (Gide-DL) group, the GBR with a Bio-Gide membrane and early implant loading (Gide-EL) group, and the GBR with an SIS membrane and early implant loading (SIS-EL) group. The allocation sequence was generated through an online tool (www. random.org) and was concealed in sealed envelopes. At 6 weeks after implant and GBR surgery, the implant stability quotient (ISQ) was measured and recorded at the labial, palatal, mesial, and distal locations via the Osstell device in the Gide-EL group and the SIS-EL group. If the ISQ was ≥ 65, definitive restoration (early loading) was performed (if < 65, the subject was withdrawn from the trial). The digital impressions and occlusal relationships were obtained via intraoral scanning, and the implant-supported crown was designed based on the digital model. Titanium base abutments with angled screw channels (ASCs) and porcelain veneered zirconia (PVZ) crowns were used for restoration. Immediately after definitive restoration, intraoral scanning was used to record the soft tissue contour at the implant site, and CBCT was used to examine the bone tissue around the implant. In addition, patients in the Gide-DL group underwent definitive restoration at 6 months after surgery (delayed loading), and the treatment process was the same as that in the Gide-EL and SIS-EL groups at 6 weeks after surgery. Clinical examination, intraoral scanning, imageological diagnosis, and aesthetic scoring were used to determine the clinical effect of SIS membranes and early implant loading at 1-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (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
- 否
入选标准
- •patients with single maxillary anterior tooth loss (sites: 12, 11, 21, 22);
- •age ≥18 years;
- •sex not limited;
- •no history of systemic diseases such as heart disease, hypertension, or diabetes;
- •no periodontal disease or already received periodontal systemic treatment;
- •cone-beam computed tomography (CBCT) revealed that the thickness of the alveolar ridge in the tooth loss area was greater than 3 mm but less than 5 mm;
- •using hydrophilic-modified sandblasted and acid-etched (SLActive) bone level tapered (BLT) dental implant systems.
排除标准
- •patients receiving radiotherapy and chemotherapy;
- •patients with a history of hepatitis, tuberculosis, or other infectious diseases;
- •patients with very poor oral hygiene;
- •patients who were heavy smokers;
- •pregnant women.
结局指标
主要结局
Marginal bone level assessment
时间窗: At the 1-year follow-up
X-ray images immediately postoperative (baseline) and at the 1-year follow-up were taken, and the distances from the most coronal bone-to-implant or bone-to-superstructure contact point to the reference point (neck margin of the implant) were measured at the mesial and distal sides of the implant; then, the data were averaged. Negative values were recorded when the contact point was at the root side of the reference point, and positive values were recorded when the contact point was at the crown side of the reference point. The data were calibrated with the known length of the implant to correct for distortion. The MBL changes were obtained by subtracting the baseline data from the 1-year follow-up data.
Soft tissue contour assessment
时间窗: At the 1-year follow-up
Intraoral scanning was used to collect the soft tissue contour at the implant site, the contour of the implant-supported crown and adjacent natural teeth. The preoperative, immediate postoperative, and 1-year follow-up intraoral scanning data in stereolithography (STL) formats were imported into Exocad 3.0 software. The best-fit images of the median sagittal section at the implant site were extracted, and the horizontal contour changes (HCCs) were measured at 1 mm and 3 mm below the crown-gingiva margin. The preoperative contour was used as the baseline to detect the immediate postoperative horizontal contour increase (HCI), and the immediate postoperative contour was used as another baseline to detect the 1-year follow-up horizontal contour decrease (HCD).
次要结局
未报告次要终点
研究者
Chao Liang
Doctor of Department of Dental Implant Center
Beijing Stomatological Hospital, Capital Medical University