Retrospective Observational Study of Implant-supported Restorations With Implants Produced by Additive Manufacturing
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Oral Surgical Procedures
- Sponsor
- M3 Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft). In addition, the biological and biomechanical performance of implant restorations supported through an observational retrospective solution will be observed. From 50 to 100 survey participants will be selected, who will be invited to attend the clinic for clinical, radiographic, and prosthetic evaluation and successful parameters between baseline, 3, 6, and 12 months. The data obtained regarding bone loss (primary outcome) of the analyzed regions and implant success and survival in area grafted with Plenum® Osshp (secondary outcome) will be evaluated by the paired t-test for the evaluation of the times (3, 6, and 12 months) and survival curves of the installed dental implants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical parameters:
- •Presence or absence of pain or tenderness
- •Presence or absence of suppuration or exudation
- •Presence or absence of mobility
- •Prosthetic parameters
- •Presence or absence of mechanical complications (problems in prefabricated components such as screws and abutments).
- •Radiographic Parameters
- •Presence or absence of peri-implant radiolucidity.
- •maintenance and quality of the bone graft volume in the grafted area to each clinical indication: ridge augmentation, extraction sites (socket preservation or dental implant preparation/placement) and sinus lifting.
- •Distance between the shoulder of the implant and the first visible bone contact (in mm).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).
Time Frame: 12 months
The main outcome is the survival rate (%) of successful implant-supported restoration after at least 1-year of occlusal loading (less than 0.5mm of bone loss)
Secondary Outcomes
- The survival rate of dental implants produced by additive manufacturing installed in different areas grafted with synthetic bone grafts (Plenum® Osshp)(12 months)
- Rate of bone loss(12 months)