NCT04438616Unknown不适用
Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment for Implant Retained Mandibular Over Denture Following Immediate Loading
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 主要终点
- name of measurement: Patient satisfaction
研究概览
简要总结
- Patients were randomly divided in to two groups by using computerized software ; the first group received flat magnetic attachment design while the second group received dome magnetic attachment design.which the inclusion criteria is completely edentulous patient ,Age range from 40 to 70 year old ,skeletal class 1, both sexes
- Implant stability will be measured for both groups using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
- Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire
详细描述
- The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group flat magnetic attachment design and study group dome magnetic attachment design technique
- Radiographic examination included a preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis.
- All patients will receive complete denture before implant installation .Constructed as the following
- Primary impression to construct diagnostic cast and special tray .
- Secondary impression with selective pressure impression technique to have master caste and occlusion block
- Face bow transfer and centric relation record will be utilized to mount the master cast on semi adjuctable articulator ,then setting the teeth and trying the denture in patient mouth.
- Processing of acrylic and lab remounting ,then delivery of the denture.
- The complete denture will be duplication to be used as a guide to fabricate the radiographic stent after placement radio opaque marker in two lower canines then send patient to perform CBCT and these duplicate denture use as surgical template to place two implant.
- CBCT machine: planmeca / CBCT soft ware : blue sky / FOV: single arch mandible /voxel size :400 Mm ( KV:90 / MA: 8 / S:11,997)
- The CBCT examination where performed in radiology department / collage of dentistry /cairo university
- serial follow up CBCT not need
- Patients were randomly divided in to two groups by using computerized software ; the first group received flat magnetic attachment design while the second group received dome magnetic attachment design e. All surgeries were performed by the same prosthodontic.
- All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine).
- A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed.
- Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor.(control and study groups)
- The flap will then be closed using interrupted 4/0 resorbable sutures.
- We connect magnetic attachment(flat,dome) for each groups on complete denture by pick up procedure at day of implant installation.
- Relief space from the denture for the magnetic attachment will be made and a rubber dam will be used to closed the under cute under the magnetic attachment. pickup material will be added in the relief area to connect the housing to the denture intra orally.
- Implant stability will be measured for both groups using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
- Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •completely edentulous patient.
- •Age range from 40 to 70 year old
- •Skeletal class 1
- •Both sexes.
排除标准
- •No intra oral soft and hard tissue pathology
- •Heavy smokers more than 20 cigarettes per day.
- •Patients with systemic disease that may affect normal healing.
- •Patient with sever parafunctional occlusal activity.
- •Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability,.
结局指标
主要结局
name of measurement: Patient satisfaction
时间窗: Patient satisfaction measure in 12 weak
Denture satisfaction questionnaire
次要结局
- name of measurement: implant stability(Implant stability will be measure after 12 weak)
研究者
Hussein Hatam Jawad
Main-Supervisor :Dr.Ahmed fahmy (Ass.professor of prosthodontics, faculity of dentistry ,cairo university ) \co-supervisor :Amr ahmednaguib (lecturer of prosthodontic ) \ Principle Investigator.:Hussein hatam jawad
Cairo University
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