NCT02907515Unknown不适用
Maintenance and Cost Effectiveness of CM-LOC Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- number of prosthodontic Maintenance events
研究概览
简要总结
The single implant overdenture (IOD) represent the simplest form of IODs compared to the 2 IOD which is the traditional gold standard IOD treatment option. Mandibular single-implant overdentures are proven to be a successful treatment option for older edentulous adults but we need to know if the CM-LOC attachment will retain its superiority over the ball attachments intraorally regarding the prosthetic complications in single implant retained overdenture like in 2 IOD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous male or female patients between the ages of 50 to
- •No contraindications for implantation.
- •Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
- •Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- •Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al[1] 1999). This will be confirmed by the CBCT.
- •Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
- •Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
- •Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated
- •All patients should have adapted to their dentures for at least six weeks before being included in the trial.
- •Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.
排除标准
- •Patients with a systemic or local contra-indication for implant placement.
- •Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
- •Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
- •Incompliant and not cooperative patients.
- •Patients smoking more than 10 cigarettes per day
结局指标
主要结局
number of prosthodontic Maintenance events
时间窗: 1 year
the number of the patient visits to the doctor to make maintenance for his implant supported overdenture
次要结局
- cost effectiveness (which treatment will cost less money)(1 year)
研究者
Amr Ahmed Naguib
assistant lecturer
Cairo University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture TreatmentMouth, EdentulousNCT02710357Universidade Federal de Goias28
已完成
不适用
Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness AnalysisEdentulous MouthNCT03691285Universidade Federal de Goias47
已完成
不适用
Cost-effectiveness of Implant Treatment for the Edentulous MandibleEdentulous MouthNCT03056976Universidade Federal de Goias37
已完成
不适用
Clinical Assessment of All Ceramic Single-retainer Using Upper Canine as Abutment With Minimum Preparation on the Lingual Surface, to Replace the Upper Lateral Incisor and Will be Compared With the All Ceramic Single-retainer Using Upper Central Incisor.Survival, ProsthesisNCT05812066Cairo University54
招募中
不适用
Costs of Implant-supported Over-Dentures (IOD) can be halved using a digital workflowNL-OMON44248Radboud Universitair Medisch Centrum36