Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Marginal bone level
研究概览
简要总结
In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. However, for multiple restorations, the abutment-prosthesis connection has not been studied in detail. The "multi-unit" systems, both standard and brand specific, have either a flat or butt joint or an cone. In any case, both are external connection systems. Recently, an internal-type abutment-prosthesis connection system has been developed. Although it is proving its usefulness in single restorations, its use in multiple restorations compared to traditional systems has not been studied.
Therefore, taking into account all of the above, the present study has the overall objective of analyzing marginal bone loss (MBL) and adaptation of soft tissues by comparing a multiple prosthesis system of the "external, flat" type versus an external system of the "internal, conical" type.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar.
- •Possibility of placing a transgingival abutment at least 2 mm high.
排除标准
- •Need for simultaneous bone augmentation.
- •Heavy smokers (>10 cigarettes/day).
- •Uncontrolled type 1 or 2 diabetes (HgA1c>8).
- •Known autoimmune or inflammatory disease.
- •Serious blood disorders, such as hemophilia or leukemia.
- •Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).
- •Liver or kidney dysfunction/failure.
- •Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy.
- •Long-term history of oral bisphosphonates use (i.e., 10 years or more).
- •History of intravenous bisphosphonates.
- •Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion.
- •Severe osseous diseases (e.g., Paget disease of bone).
- •Pregnant women or nursing mothers.
- •Not able or not willing to follow instructions related to the study procedures.
研究组 & 干预措施
Connect®
Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.
干预措施: Connect® (Device)
Multi-unit
Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.
干预措施: Multi-unit (Device)
结局指标
主要结局
Marginal bone level
时间窗: 1 year
Peri-implant marginal bone level measured by standardized periapical radiography
次要结局
- Peri-implant microbiome(1 year)
- Peri-implant inflammation(1 year)
研究者
Miguel Padial-Molina
Associate Professor
Universidad de Granada