Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion in Thin Mandibular Ridge on Patient Satisfaction:
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 主要终点
- patients satisfaction
研究概览
简要总结
The better form of ridge will provide using wider implants that can have better abilities to with stand forces and to prevent alveolar bone loss as much as possible. Ridge expansion gained some popularity due to easiness compared to any other procedure that can gain bone. However, this treatment modality needs to be evaluated as compared to Mini Dental Implants (MDIs) over denture in thin mandibular ridge.
In mandibular edentulous patients having thin ridge, does the mini implant supported over denture, compared to the conventional implant supported over denture after bone expansion affect bone height around implants?
详细描述
PICO
P: Completely edentulous Patients.
I: Mandibular overdenture supported by mini dental implant.
C: Mandibular overdenture supported by conventional implant diameter after bone expansion.
O: outcomes as follows:
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)
盲法说明
The Principal investigator ,main supervisor and co-supervisor cannot be blinded as the implant placement technique for both groups will be different. In addition during assessment of 2ry outcome (bone height change) the x-ray will reveal the difference in the shape of both types of implants thus assessor couldn't be blind.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous patients ranging from age 35 to 75 years
- •Angle's Class I skeletal relationship
- •Normal facial symmetry
- •Cooperative patients
- •Adequate inter-arch space not less than 12mm
排除标准
- •Temporomandibular disorders
- •Uncontrolled diabetes
- •Bleeding disorders or anticoagulant therapy
- •Flabby tissues or sharp mandibular residual ridge.
- •Heavy smokers.
- •Patient's with neuromuscular disorders
- •Patients on chemotherapy or radiotherapy
- •Severe psychiatric disorders
- •Angle's class II and III skeletal relationship
研究组 & 干预措施
Mini Dental implant
2 mini dental implant of diameter 2.8 mm with length 10 mm will be inserted mandiblular ridge ≥5 mm mesial to the mental foraminato support overdentures for the intervention group.
干预措施: Mini dental implant (Device)
conventional implant
two slandered implant diameter 3.7 mm and length 10 mm will be placed in interforaminal region of mandiblular ridge support overdenture for the compartor group.
结局指标
主要结局
patients satisfaction
时间窗: after six months of over denture insertion
Visual analogue scale: a scale from 0-10 where 0 represents unsatisfied and 10 represents highly satisfied.
次要结局
- Bone height change(baseline (T0) initial bone height (millimetres), after six months usage of over denture(T1) bone height (millimetres), then after twelve-months usage of over denture(T2) bone height. 1st period (T1-T0) after 6 months 2nd period (T2-T1) after 12 months)
研究者
Osama Ahmed Aboelfetooh
Principle investigator
Cairo University