A Randomized Controlled Trial Comparing Titanium Grade V (KS) Versus Titanium Grade IV (TS) Implants for the Treatment of Edentulous Mandible
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implant
- Sponsor
- Università degli Studi di Sassari
- Enrollment
- 48
- Primary Endpoint
- Rate of implant stability
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Investigators
Marco Tallarico
Assistent Professor
Università degli Studi di Sassari
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Rate of implant stability
Time Frame: Up to 5 years
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 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.
Number of 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 reaso
Number of complications
Time Frame: Up to 5 years
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.
Secondary Outcomes
- Peri-implant marginal bone level changes(At 1,3 and 5 years)
- Patient satisfaction(At 1,3 and 5 years)