Dental Implant, Dental Implant-Abutment Design, Edentulous Jaw
Conditions
Keywords
Dental Implant, Overdenture, Implant-abutment connection
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
Interventions
DEVICEImplant placement with 3.5 mm diameter KS implants.
Implant 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.
DEVICEImplant placement with 3.5 mm diameter TS implants.
Implant 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.
Sponsors
Melodia, Dario, M.D.
Pisano, Milena, M.D.
Dr. Aurea Lumbau
Prof. Silvio Mario Meloni
Prof. Edoardo Baldoni
Università degli Studi di Sassari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis.
Intervention model description
A multicenters, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of implant failure | 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 | 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 | 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. |
| Rate of implant stability | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant marginal bone level changes | At 1,3 and 5 years | 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. |
| Patient satisfaction | At 1,3 and 5 years | 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. |
Outcome results
None listed