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| Name | Class |
|---|---|
| Melodia, Dario, M.D. | INDIV |
| Pisano, Milena, M.D. | INDIV |
| Dr. Aurea Lumbau | UNKNOWN |
| Meloni, Silvio Mario, M.D. |
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To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ks dental implant | Experimental | Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using KS implant with 3.5 mm of diameter |
|
| TS dental implant | Active Comparator | Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using TS implant with 3.5 mm of diameter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant placement with 3.5 mm diameter KS implants. | Device | Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants. with 3.5 mm diameter KS implants.After osseointegration, both dental implants will receive definitive prosthesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of implant failure | Defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable. | Up to 5 years |
| Number of prosthesis failure | Whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reaso | Up to 5 years |
| Number of complications | echnical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complications will be considered. | Up to 5 years |
| Rate of implant stability | The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-implant marginal bone level changes | Peri-implant marginal bone level changes will be assessed on periapical radiographs took with the paralleling technique at implant placement, at initial loading, 1,3 and 5 years after loading. Ideally digital radiographs should be taken, otherwise radiographs on conventional films will be scanned into TIFF format with a 600 dpi resolution, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the first two consecutive threads. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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| INDIV |
| Baldoni, Edoardo, M.D. | INDIV |
A multicenters, randomized controlled trial.
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A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis.
|
| Implant placement with 3.5 mm diameter TS implants. | Device | Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants. with 3.5 mm diameter TS implants.After osseointegration, both dental implants will receive definitive prosthesis. |
|
| At 1,3 and 5 years |
| Patient satisfaction | Patients will answer the following questions (separately for each implant):
| At 1,3 and 5 years |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |