RCT Comparing KS Versus TS for Ovedenture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Sassari
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Any edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length.
18 years or older, and able to sign an informed consent.
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.
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
Design model
Parallel
Treatments tested in this trial
Implant placement with 3.5 mm diameter KS implants.
DeviceImplant 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.
Implant placement with 3.5 mm diameter TS implants.
DeviceImplant 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Ks dental implantExperimental treatment 1 intervention
Group B: TS dental implantActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 5 years2
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
Time frame
Up to 5 years3
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.
Time frame
Up to 5 years4
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.
Time frame
Up to 5 yearsSecondary outcomes
1
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.
Time frame
At 1,3 and 5 years2
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".
Time frame
At 1,3 and 5 yearsLocations
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
Source ClinicalTrials.gov
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