Comparison of the Dimensional Changes of Hard and Soft Peri-implant Tissues Around Single Immediate Post-Extraction Implants in the Esthetic Zone With Socket Shield Technique Versus Using Xenograft: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- pink esthetic score
研究概览
简要总结
The aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone.
详细描述
to compare the efficacy of the socket shield technique in counteracting the dimensional changes of the soft and hard peri-implant tissues to filliing the buccal gap with xenograft.
- Population (P): Patients with single non-restorable tooth in the esthetic zone.
- Intervention (I): Immediate implant placement with socket shield technique.
- Comparator (C): Immediate implant placement and filling the buccal gap with xenograft.
- Primary Outcome (O): Pink Esthetic Score (PES) (Fürhauser et al., 2005).
- Time frame: 9 months (Chu et al., 2015).
- Study design: Randomized controlled clinical trial.
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
- 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
- 是
入选标准
- •Patient's age was 18 years or older.
- •Non-restorable tooth in the upper inter-bicuspid area.
- •Adequate bone volume for the placement of immediate implant.
- •Following tooth extraction, there was an intact socket bony wall (type I extraction socket).
- •Primary stability of the implant was achieved at the time of the implant placement.
排除标准
- •Patients who reported tobacco use in the past 5 years.
- •Patients who had severe periodontal destruction at the site of implant placement.
- •The presence of any signs of acute infection in the surgical site or the adjacent two natural teeth.
- •Patients who had history of any systemic disease that precludes the placement of implants.
- •Any disease that might affect bone metabolism as osteoporosis.
- •Patients taking medications that might affect bone turn over as bisphosphonates.
- •Physically or mentally handicapped patients.
- •Pregnant females.
- •Teeth with vertical root fractures on the buccal aspect
- •Teeth with any other pathologies affecting the buccal part of the root, for example, external or internal resorptions.
研究组 & 干预措施
experimental
immediate implant with socket shield technique
干预措施: socket shield technique (Procedure)
control
immediate implant placement with filling the buccal gap with xenograft
干预措施: xenograft (Procedure)
结局指标
主要结局
pink esthetic score
时间窗: 9 months
Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
次要结局
- Recession of the buccal peri-implant mucosa(9 months)
- Corono-apical peri-implant bone dimensional changes(6 months)
- Bucco-lingual peri-implant bone dimensional changes(6 months)
- Patient satisfaction: VAS(9 months)
研究者
Mohamed Atef Abd El Moneium
assistant lecturer
Cairo University