Supra-Implant Complex Stability Following Flapless Immediate Implant Placement With Socket Shield Technique Versus Connective Tissue Graft in Anterior Maxilla 1-Year 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
- 28
- 试验地点
- 1
- 主要终点
- Soft tissue Volume gain/loss
研究概览
简要总结
The present study aims to compare the dimensional stability of the supra-implant complex following flapless immediate implant placement using two socket management approaches: the connective tissue graft and the socket shield technique. Three-dimensional volumetric analysis and cone-beam computed tomography (CBCT) will be employed to assess and quantify changes in soft and hard tissue thickness and height surrounding the implant site.
详细描述
The current study will include 28 non-restorable single maxillary anterior teeth indicated for extraction. Patients will be randomly allocated into two equal groups. The test group will undergo immediate implant placement combined with the socket shield technique and a customized healing abutment, whereas the control group will receive immediate implant placement with connective tissue grafting and a customized healing abutment. A pilot surgical guide will be used for both groups. The primary outcome measure will be labio-palatal ridge dimension changes changes. Secondary outcome measures included labial soft-tissue volumetric changes, bone formation labial to the implant, vertical bone level changes and pink esthetic score. All outcomes will be evaluated after a 12-month follow-up period.
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
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Initial intact thick gingival biotype
- •2 mm band of keratinized tissue,
- •Thin intact labial bone plate (< 1mm)
- •Good apical bone for primary stability
- •Patients who had provided an informed consent.
排除标准
- •Immediate implants with bone grafts or guided bone regeneration procedures
- •Uncontrolled diabetes mellitus
- •Patients taking IV bisphosphonates for treatment of osteoporosis
- •Patients with active infection related at the site of implant
- •Patients with untreated active periodontal diseases.
结局指标
主要结局
Soft tissue Volume gain/loss
时间窗: one year
The volumetric analysis in this clinical trial will be performed to obtain profilometric measurements. intraoral scans will be taken at baseline, 6- and 12-month post-operative for each patient. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. Unchanged neighboring teeth surfaces will be used as a reference for proper superimposition. In each patient, the AOI will be kept constant for all pairwise comparisons. The volumetric analysis software will calculate the overall buccal soft tissue volume loss/gain (mm3) within the AOI for each patient.
次要结局
- Mid-facial gingival margin level(12 months)