Background
Methods
-
Group A received 10 OSPTX implants using the soft bone surgical protocol (OSPTXSoft).
-
Group B received 10 OSPTX implants using the standard surgical protocol (OSPTXStd).
-
Group C received 10 OSP implants using the standard surgical protocol (OSPStd).
Inclusion | Male or female |
At least 18 years old | |
Healthy enough to undergo routine implant surgery and subsequent dental treatment | |
Partially edentulous requiring single dental implants in the maxilla | |
Adequate volume of native or grafted bone to accommodate dental implants at least 8 mm long | |
No active infections | |
Physically, emotionally, and financially able to undergo planned implant procedures | |
Adequate compliance to meet study requirements and necessary appointments | |
Exclusion | Medical need for antibiotic premedication for infective endocarditis, artificial joints, or any other medication |
Uncontrolled hypertension | |
Uncontrolled diabetes | |
Serological human immunodeficiency virus (HIV) positive | |
History of significant heart, stomach, liver, kidney, blood, immune system, or other organ impairment or systemic disease that would prevent undergoing the proposed treatment | |
Smoke cigarettes or other tobacco products | |
Use of investigational drugs during the previous month | |
Unresolved dental conditions likely to require exiting the study for treatment, such as deep cavities, abscesses, or moderate to severe periodontal disease | |
History of radiation therapy to the head and neck | |
Unwilling or inability to sign the informed consent form | |
Failure to demonstrate willingness to return for a required number of visits | |
Need immediate dental implant placement following tooth extraction |
Results
Implant success | Clinically immobile when tested manually and/or with RFA (minimum ISQ = 65) |
Absence of peri-implant radiolucency present on an undistorted radiograph | |
Absence of unresolved pain, discomfort, infection or neuropathy, or peri-implant soft tissue complications attributable to the implant | |
Implant placement that does not preclude delivery of a prosthetic crown with an appearance that is satisfactory to the patient and the dentist | |
Crestal bone loss that is <1.5 mm after the first year of loading followed by not more than 0.2 mm of annual crestal bone loss thereafter | |
Prosthesis success | Absence of unresolved peri-implant soft-tissue complications, such as bleeding, swelling, suppuration or recession, attributable to the prosthetic restoration |
Absence of unresolved prosthetic complications, such as screw loosening or porcelain fracture | |
Absence of esthetic complications, such as implant or abutment visibility, or compromised porcelain translucency or mismatched prosthetic tooth color | |
Early loading success: a functional provisional crown placed ≥3 weeks and <3–6 months after implant placement, followed by delivery of a definitive crown after 12 months of function |