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compare fully versus partially guided all on four implants placement immediately loaded by maxillary and mandibular screw retained overdentures: A radiographic and photogrammetric measurement of accuracy of implant position and passivity of superstructures.
The measurements will be done as follows:
Sixteen healthy, fully edentate patients will be selected from the Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be informing about the protocol of the study and, they will sign a written consent. The study will be ethically approved according to the faculty of dentistry principles.
Sample size and study design A power analysis was made using a computer software (G* power) to detect the prober sample size based on the results of a previous study in which the authors found a significant difference in mesiodistal measurements between two groups (computer guided implant placement Vs conventional implant placement) using a similar study design. The sample size calculation yields a total of 32 implants (16 implants\ each group) using independent samples t-test. The following are details of sample size calculation: effect size= 0.904, Alpha (α)= .050. power (β)= .80
Patient selection i- Completely healed residual alveolar ridges ii- Angle's class I maxillo-mandibular relationship. iii- Sufficient mandibular and maxillary restorative spaces, at least 15mm evaluated by recording a tentative jaw relation.
iv- Adequate bone height in the premaxilla area, and the anterior mandibular area. This will be evaluated radiographically Exclusion criteria included (i) Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
(ii) Local or general contraindication for surgical procedures. (iii) History of chemotherapy or radiation therapy to the head and neck area. (iv) Poor neuromuscular co-ordination. (v) TMJ dysfunction and parafunctional habits
Construction of conventional complete denture:
Each patient will receive conventional complete denture and will be delivered and followed to adjust any post operative complains
Construction of surgical guide by dual scan technique:
- According to the virtual 3D planning and surgical guide designing for implant instalment, patients will randomly be divided into two equal treatment groups as follows: Group (I): partially- guided (PG) implant instalment Group (II): fully- guided (FG)implant instalment
Photogrammetic scanning:
For both groups based on the implant planning position and angulation a presurgical 3D printed model with digital analogue spaces will be constructed and scanned using photogrammetric device after connecting the multiunit digital analogues to the printed model in order to be compared to the model formed after implants placement in each group using photogrammetric device.
Implant instalments:
Construction of screw retained mandibular and maxillary overdentures
Methods of evaluation:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| partially- guided (PG) implant instalment | Active Comparator | partial guided allow control until the drill before the last one using universal drilling kit and the final osteotomy done with the system specific finishing drill after removal of the surgical guide. |
|
| fully- guided (FG)implant instalment | Active Comparator | Fully guided guides allow complete guidance to the drills tell the final one in addition to implants placement through the guide with control to the implant timing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cone beam computed tomography | Device | -Implant marginal bone height changes will be measured by cone beam radiograph after one and two years of loading |
|
| Measure | Description | Time Frame |
|---|---|---|
| accuracy of implant insertion | accuracy of implant position will be measured immediately after implant insertion by using photogrammetry scan for implants with multi-unit abutments intra-orally and on the model created from the planned implants and fitting surface of surgical guide, superimposition of both scans will be done using geomagic software to determine deviation in implant positions between both scans (Presurgical and post surgical) for both groups and calculated in fractions of millimeters, the value of deviation found in both semi-guided and fully-guided groups will be compared. | immediately after implant insertion |
| Measure | Description | Time Frame |
|---|---|---|
| passive fit of final prosthesis | passivity of final prosthesis will be evaluated by radiography and gap distance will me measured on radiographic software in fractions of millimeters | immediately after final restoration insertion |
| Marginal bone loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Shady Mohamed Shady, MD | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University, Faculty of Dentistry, mansoura, egypt | Al Mansurah | Mansoura | Egypt |
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According to the virtual 3D planning and surgical guide designing for implant instalment, patients will be randomly divided into two equal treatment groups (4 patients for each) as follows:
Group (I): partially- guided (PG) implant instalment Group (II): fully- guided (FG)implant instalment both groups will be subjected to:
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| photogrammetric scan using elite scanner (shining 3d) | Device | implant placement accuracy will be evaluated using photogrammetric scan after implant insertion |
|
Implant marginal bone height changes will be measured by cone beam radiograph after one and two years of loading
| 24 months after prosthesis insertion |
| ID | Term |
|---|---|
| D054893 | Cone-Beam Computed Tomography |
| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D014056 | Tomography, X-Ray |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
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