Peri-implant Soft Tissue Conditioning of Immediate Posterior Implants by CAD/CAM Socket Sealing Abutments (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pink esthetic score
研究概览
简要总结
One of the major challenges one clinician can face while performing immediate placement on posterior area, is the ability of obtaining a hermetic primary closure of the soft tissue. The use of socket sealing abutment may provide advantages in maintaining the existing soft tissue architecture, preserving crestal bone height and reducing the risk of premature loading of the immediate implant during healing
详细描述
One of the major challenges one clinician can face while performing immediate placement on posterior area, is the ability of obtaining a hermetic primary closure of the soft tissue. This technical skill is nearly always combined with invasive surgical procedures and significant post op recovery (displacement of the muco-gingival line, periosteal releasing incision, flaps, sutures, membrane stabilization, ...).the use of customized healing abutment may provide advantages in maintaining the existing soft tissue architecture, preserving crestal bone height and reducing the risk of premature loading of the immediate implant during healing.
Moreover, customized healing abutment can passively accommodate the definitive prosthesis with minimal or no pressure placement preventing biological or mechanical trauma during the prosthetic phases. This may lead to better long-term tissue stability and avoid the pain perceived by the patients from compression of tissues in case of standard healing abutment.
the primary aim of this randomized controlled clinical study is to clinically evaluate and compare the soft tissue outcomes of final immediate implant restorations placed in maxillary posterior sites that were conditioned by CAD/CAM fabricated socket sealing abutments versus standard healing abutments.
The secondary aim of this study is to radiographically assess peri-implant bone level changes of the final immediate implant restorations placed in maxillary posterior sites for the two experimental groups.
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 (Investigator, 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
- •The patients ≥18 years old.
- •Non-restorable maxillary posterior teeth with intact adjacent teeth.
- •Sufficient bone to insert a dental implant with a minimum length of 8 mm and at least 3.5 mm in diameter.
- •Type1 extraction socket according to Elian et al, 200742 (Labial bone plate and associated soft tissues are completely intact).
- •Sufficient mesio-distal, bucco-lingual, and inter-occlusal space for placement of the definite restoration.
- •Adequate oral hygiene (full mouth plaque score < 25% and full mouth bleeding score < 25%).
- •Patients capable of understanding and giving informed consent.
排除标准
- •Alcohol or drug abusers.
- •Heavy smokers (> 10 cigarettes/day).
- •Presence of acute periapical infections.
- •Radiotherapy to the head and neck region for malignancy.
- •Bruxism or TMJ dysfunction.
- •Intake of drugs affecting bone metabolism.
- •Uncontrolled diabetic patients.
- •Pregnant women.
研究组 & 干预措施
CAD/CAM customized Socket Sealing Abutment
Anatomically formed healing abutments that can solve many of the problems inherent to immediate posterior implant placement and to optimize the conditioning of supra implant tissue architecture enhancing the emergence profile of the final implant restoration
干预措施: cad/cam socket sealing abutment (Procedure)
Standard healing abutment
Standard healing abutment will be inserted after removal of cover screw after immediate implant insertion and then a muco-periosteal flap will be reflected for the primary closure of the socket and sutured around the standard healing abutment.
干预措施: standard healing abutment (Procedure)
结局指标
主要结局
Pink esthetic score
时间窗: one year of follow up
clinical evaluation of soft tissue profile around the implant restorations with minimum score of 0 and maximum score of 10
次要结局
- Functional implant prosthodontic score(one year of follow up)
研究者
Mai Elgendi
Assistant lecturer
Cairo University
