Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment for Implant Retained Mandibular Over Denture Following Immediate Loading

Conditions
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Edentulous Alveolar Ridge

Intervention / Treatment
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* Procedure: dome magnetic attachment
* Procedure: flat magnetic attachment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: completely edentulous patient. Age range from 40 to 70 year old Skeletal class 1 Both sexes. Exclusion Criteria: 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,.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dome magnetic attachment<br>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 We connect magnetic attachment(dome) for each groups on complete denture by pick up procedure at day of implant installation | Procedure: dome magnetic attachment<br>* All patients will receive complete denture before implant installation . The CBCT examination should be take patients received infiltration local anesthesia A crestal incision is made using No. 15 c blade . Full sequential drilling under copious saline irrigation will be made . insertion of two implant by the contra angle handpiece with special adaptor We connect magnetic attachment(dome) on complete denture by pick up procedure at day of implant installation. Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks. Patient satisfaction measure<br>|
| Active Comparator: flat magnetic attachment<br>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 We connect magnetic attachment(flat) for each groups on complete denture by pick up procedure at day of implant installation | Procedure: flat magnetic attachment<br>* All patients will receive complete denture before implant installation . The CBCT examination should be take patients received infiltration local anesthesia. A crestal incision is made using No. 15 c blade Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant by the contra angle handpiece with special adaptor We connect magnetic attachment(flat) on complete denture by pick up procedure at day of implant installation. Implant stability will be measured 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| name of measurement: Patient satisfaction | Denture satisfaction questionnaire | Patient satisfaction measure in 2 weak | 
| name of measurement: Patient satisfaction | Denture satisfaction questionnaire | Patient satisfaction measure in 12 weak | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| name of measurement: implant stability | Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe. | Implant stability will be measure at day of implant | 
| name of measurement: implant stability | Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe. | Implant stability will be measure after 2 weak | 
| name of measurement: implant stability | Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe. | Implant stability will be measure after 4 weak | 
| name of measurement: implant stability | Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe. | Implant stability will be measure after 8 weak | 
| name of measurement: implant stability | Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe. | Implant stability will be measure after 12 weak |