SOI Immediately vs Delayed
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Sassari
About this trial
The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Any patient with at least one hopeless tooth in the mandible or maxilla, located between premolars, with intact post extractive alveolus. The implants must to engage at least 3 (mandible) to 5 (maxilla) mm of residual native bone over the socket.
Patients with 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). Heavy smokers will be excluded.
Biotype will be categorized in thin (≤1 mm), medium (>1 - <2 mm) or thick (≥2 mm).
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
Immediately implant placement
DeviceAfter atraumatic tooth extraction immediate implant placement with SOI surface and loading will be performed with temporary restoration. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive restoration will be delivered
Delayed
DeviceAfter atraumatic tooth extraction, the extraction site will be left to heal for 4 months, just grafting with A-Oss and suture, according to a socket preservation procedure. Four month later, implant will be place and immediate loadind with temporary restoration will be performed. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive restoration will be delivered
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Immediately implant placementExperimental treatment 1 intervention
Group B: Delayed implant placementActive 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. 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, immediately loading, at 1,3 and 5 years after loading for the partial fixed prostheses. Once the single crowns will be cemented, their stability will be assessed by rocking the crown with the handles of two dental instruments.
Time frame
Up to 5 years3
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.) complication will be considered.
Time frame
Up to 5 yearsSecondary outcomes
1
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.
Time frame
At 1,3 and 5 years2
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".
Time frame
At 1,3 and 5 years3
Rate of implant stability quotient (ISQ)
ISQ was measured and recorded using the IS3 (Osstem), at implant placement, at implants exposure, at the impression time, and prosthetic loading.
Time frame
Up to 5 years4
Valuation of soft tissue thickness and amount of keratinized tissue
The soft tissue biotype will be investigated by the same surgeon at the surgical procedures using a periodontal probe into the sulcus. Greater will be the thickness of the tissue, smaller will be transparency of the periodontal probe. The amount of keratinized tissue will be evaluated 1 year after surgical procedures using a periodontal probe. This outcome will be evaluated according to the distance from the gingival margin to the mucogingival junction
Time frame
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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