About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
General contraindications to implant surgery.
Patients irradiated in the head and neck area.
Immunosuppressed or immunocompromised patients.
Patients treated or under treatment with intravenous amino-bisphosphonates.
Trial design
Parallel
Treatments tested in this trial
Implant placement TS III
DeviceImplant 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.
Implant placement ks
DeviceImplant 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
Valuation of patient satisfaction
Patients will answer the following questions (separately for each implant): 1. Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. 2. Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. 3. Would you undergo the same therapy again? Possible answers: "yes" or "no".
Sponsors and contacts
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Università degli Studi di Sassari
Lead sponsor
Melodia, Dario, M.D.
Collaborator
Pisano, Milena, M.D.
Collaborator
Dr. Aurea Lumbau
Collaborator
Meloni, Silvio Mario, M.D.
Collaborator
Baldoni, Edoardo, M.D.
Collaborator
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