Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- change in oral health related quality of life using (oral health impact profile edentulous) questionnaire (OHIP-EDENT)
研究概览
简要总结
Comparing the quality of life and periimplant condition around a single implant retained mandibular overdenture in two groups one will have a ball attachment and the other is having a (CM-LOC) one.
详细描述
Single implant retained mandibular overdenture is considered an economic and simple treatment modality for edentulous subjects. Resin matrix (CM LOC) is one of the low profile attachments which represent a promising retention values with subsequent improvement in chewing ability and in turns enhance patient quality of life.Oral health impact profile for edentulous patient (OHIP-EDENT) is more specific to edentulous subjects.
Peri-implant soft tissue health (bleeding, inflammation, etc...) is a valuable marker to implant success. The study will record different attachment influenced-tissue response and its relation to implant success and oral health related quality of life (OHRQOL)
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
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 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.
研究组 & 干预措施
CM LOC attachment
CM LOC attachment other names: resin matrix attachment
干预措施: CM LOC attachment (Device)
ball attachment
ball attachment other names metallic ball attachment
干预措施: ball attachment (Device)
结局指标
主要结局
change in oral health related quality of life using (oral health impact profile edentulous) questionnaire (OHIP-EDENT)
时间窗: from baseline up to 5 years
likert scale from 0-4
次要结局
- change in modified gingival index(from baseline up to 5 years)
- modified bleeding index(from baseline up to 5 years)
- change in plaque index(from baseline up to 5 years)
研究者
Marwa Abdelaal Mohammed
Assisstant Lecturer
Cairo University