A 5-year Prospective Randomised Clinical Study on the Efficiency of Three Different Attachment Systems as Retention for Implant-supported Mandibular Overdenture.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- The following parameters will be assessed for implant survival: - Gingiva-score, Plaque-score, Calculus, Bleeding-score, Probing pocket depth and Implant stability will be measured using Osstell (RFA).
研究概览
简要总结
The aim of the investigators study is to compare, in a prospective controlled clinical trial, the Locator® System with two other types of stress-breaking retention (Retentive Anchors and Magnets) for implant supported overdenture in atrophic edentulous mandible, with the use of Straumann Dental Implant System.
详细描述
The study was divided in two parts - in the first part of the study 46 fully mandibular edentulous patients will be enrolled. The patients will be recruited from the University Hospital of Dentistry and 9 other private practices in Bucharest and surrounding areas.
Selected patients will be informed about the two different treatment options, about the benefit of treatment with an overdenture retained by two endosseous implants and a written informed consent will be obtained from all participants.
Initial examination
At the beginning of the treatment for each patient will be recorded:
- The medical status.
- The dental history, oral and radiographic examination.
- The hygiene status.
- An evaluation of the existing dentures.
- The estimation of dysfunctional problems.
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
- None
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
- •Complains about the stability of the existing mandibular denture satisfactory from a technical point of view.
- •Acceptance of a mandibular over-denture retained by two endosseous implants.
- •Patients agree to a 5-year follow-up period.
排除标准
- •Insufficient bone volume (height and with) for inserting at least a 10 mm implant (Ø 4,1).
- •Angle class II relationship.
- •Physical severe consideration that will affect the minimal invasive surgical procedure or constitute a hindrance for a 5-year follow-up.
- •History of radiotherapy in the head and neck region.
- •History of pre-prosthetic surgery (including bone graft procedures) or previous oral implants.
结局指标
主要结局
The following parameters will be assessed for implant survival: - Gingiva-score, Plaque-score, Calculus, Bleeding-score, Probing pocket depth and Implant stability will be measured using Osstell (RFA).
时间窗: 5 years
次要结局
- Radiographic outcome: Standardised intra-oral radiographs will be made using the long cone technique. Prosthetic maintenance and complications and soft-tissue complications of the denture bearing area will be recorded.(5 years)
- Patient satisfaction will be assessed with the aid of questionnaires: initial (with the original denture), after 6 months, 1-year and 5 years. Final costs for each type of retention will be calculated according to all the procedures and complications.(5 years)
研究者
Corina Marilena Cristache
Dr Corina Marilena Cristache, DMD, PhD, senior lecturer
Concordia Dent Srl