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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 compare the clinical and radiographic outcomes of two different implant systems with different implant-abutment connection: Osstem TS III (control group) versus Osstem KS (study group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ks dental implant | Experimental | Innovative dental implant with lasting, internal conical connection of 15° and strengthened implant walls. |
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| TSIII dental implant | Active Comparator | Standard dental implant with internal conical connection of 11°. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant placement TS III | Device | Implant placement in subjects who have lost at least two teeth and need a prosthetic implant rehabilitation with TSIII Implant. . After osseointegration, dental implants will receive definitive prosthesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with 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. 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 |
| Number of Participants with 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 reason. | Up to 5 years |
| Number of complications | Technical (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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of 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:
Any partially edentulous patient with partial edentulism, requiring at least two dental implant-supported rehabilitations, being 18 years or older, and able to sign an informed consent. Implant sites must allow the placement of two implants of at least 4 (premolars) or 4.5 (molars) mm of diameter and 8.5 mm of length. Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study. Implants can be adjacent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marco Tallarico | Sassari | 07100 | Italy |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 21, 2026 |
| INDIV |
| Baldoni, Edoardo, M.D. | INDIV |
Split-mouth
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The patients, the outcome assessors (when possible) and the statistical advisors will be blind to the used implant
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| Implant placement ks | Device | Implant placement in subjects who have lost at least two teeth and need a prosthetic implant rehabilitation with KS Implant. After osseointegration, dental implants will receive definitive prosthesis. |
|
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| At 1,3 and 5 years |
| Valuation of patient satisfaction | Patients will answer the following questions (separately for each implant):
| At 1,3 and 5 years |