The Use of an Innovative, Thickened and Lasting Implant Comparing KS Versus TS Implants for Prosthetic Rehabilitations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Number of complications
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The patients, the outcome assessors (when possible) and the statistical advisors will be blind to the used implant
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
- •Patients with untreated periodontitis.
- •Patients with poor oral hygiene and motivation.
- •Previous guided bone reconstruction at the intended implant sites.
- •Uncontrolled diabetes.
- •Pregnancy or nursing.
- •Substance abuser.
- •Psychiatric problems or unrealistic expectations.
- •Lack of opposite occluding dentition in the area intended for implant placement.
- •Patients with infection and or inflammation in the area intended for implant placement.
- •Patients participating in other studies, if the present protocol cannot be properly adhered to.
- •Patients referred only for implant placement and cannot be followed ant the treating centre.
- •Patients unable to be followed for 5 years.
Outcomes
Primary Outcomes
Number of complications
Time Frame: Up to 5 years
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.
Number of Participants with implant failure
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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.
Secondary Outcomes
- Rate of peri-implant marginal bone level changes(At 1,3 and 5 years)
- Valuation of patient satisfaction(At 1,3 and 5 years)
Investigators
Marco Tallarico
Assistant professor
Università degli Studi di Sassari