Soi TS3 Surface in Patients With and Without Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Sassari
About this trial
The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients of at least 18 years old able to sign an informed consent.
Patients with at least a single tooth loss in the maxilla or mandible. Patient will provide only one site for the research. Implant sites must allow the placement of implants of at least 3.5 mm (upper laterals and lower incisors); 4 mm (central incisors, canines, and premolars) or 4.5 (molars) mm of diameter and at least 7 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).
Patients with a plaque index (PI) of less than, or equal to 25% at the time of surgery.
Disqualifiers
General contraindications to implant surgery (except for type two diabetes in test group).
Patients irradiated in the head and neck area.
Immunosuppressed or immunocompromised patients (except for type two diabetes in test group).
Patients treated or under treatment with intravenous amino-bisphosphonates.
Trial design
Design model
Parallel
Treatments tested in this trial
Implant placement with soi surface in diabetic subjects
DeviceImplants placement with SOI surface in subjects with diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
Implant placement with soi surface in healthy subjects
DeviceImplants placement with SOI surface in subjects without diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Diabetics groupExperimental treatment 1 intervention
Group B: Healthy GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 reason
Time frame
Up to 5 years2
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 years3
Number of complication
Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complication will be considered
Time frame
Up to 5 yearsSecondary outcomes
1
Rate of peri-implant marginal bone level changes
eri-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
Valuation of patient satisfaction
Patients will answer the following questions (separately for each implant): Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. Would you undergo the same therapy again? Possible answers: "yes" or "no
Time frame
At 1,3 and 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Università degli Studi di Sassari
Lead sponsor
Melodia, Dario, M.D.
Collaborator
Pisano, Milena, M.D.
Collaborator
Dr. Aurea M. I. Lumbau
Collaborator
Meloni, Silvio Mario, M.D.
Collaborator
Baldoni, Edoardo, M.D.
Collaborator
Source ClinicalTrials.gov
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