Partial Edentulism, Tooth Disease
Conditions
Keywords
dental implants, Osseotite Certain Prevail, multicenter, observational, clinical study, partial edentulism, single stage, immediate occlusal loading, crestal bone level, short fixed bridge
Brief summary
This prospective, multicenter study evaluates the performance of the Osseotite Prevail implant when to support a short fixed bridge with immediate occlusal loading, providing the patient with the use of a temporary prosthesis until the final prosthesis is made. Study (null) hypothesis: This is an observational study in which no concurrent control group will be observed. Results of the study will be compared with the performance of other Osseotite implants from published Osseotite multicenter studies.
Detailed description
This is a prospective, observational study in which all the patients will have implants placed and a provisional prosthesis attached within 24 hours of implant surgery. Each restorative case will consist of a posterior short span fixed bridge of four implants or less. The final prosthesis will be placed within five months or implant placement surgery. Overall success will be determined on the basis of procedural success, prosthesis success, and implant success.
Interventions
None listed
Sponsors
ZimVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients of either sex and of any race, 18 years of age or older * patients for whom the decision has already been made to use dental implants for treating partial edentulism in the posterior mandible or maxilla using a short span fixed prosthesis of two to four units * patients must be physically able to tolerate conventional surgical and restorative procedures * requirements for implant placement include: at least 1mm bone will be available at the buccal and lingual aspect of the implant and at least 1mm of bone below the apex * patients must agree to return to the clinic for each study follow-up visit * requirements for prosthetic fabrication include: bone width at least 6mm and a bone height of at least 11mm
Exclusion criteria
* patients with active infection or severe inflammation in the areas intended for implant placement * patients with a \>10 cigarettes / day smoking habit * patients with uncontrolled diabetes or metabolic bone disease * patients with a history of therapeutic radiation to the head * patients in need of bone grafting at the site of the intended study implant; if at the time of surgery some lateral voids need to be filled this is acceptable and does not exclude the patient from the analysis * patients who are known to be pregnant * patients with para-functional habits with evidence of severe bruxing or clenching * placement of implants into sites with less than sixteen weeks of post-extraction healing; for 3-4 unit cases one implant site may have less than sixteen weeks of healing prior to implant placement * type III or IV bone characteristics of the intended implant sites * inter-arch distance of less than 7mm (planned location of implant seating platform to the apposing occlusal landmark)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Implants Achieving Osseous Integration | 1 year | Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis. |
Secondary
| Measure | Time frame |
|---|---|
| Crestal Bone Regression | four years |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHessam Nowzari, DDS
University of Southern California
Participant flow
Recruitment details
Each site endeavored to enroll a maximum of 15 patients, with enrollment efforts beginning in March 2005. Enrollment period remained open at all sites until April 2006. Three participating sites are Universities and four are private practices.
Pre-assignment details
Pre-treatment included a screening visit(enroll those meeting all study inclusion criteria), signing informed consent, and pre-surgical data collection. Within 48hrs., impressions of the patient's treatment areas are taken for making a temporary prosthesis. Patients are then scheduled for implant placement surgery.
Participants by arm
| Arm | Count |
|---|---|
| Osseotite Certain Prevail Implant Internal connection implant with an expanded platform and lateralization with a tapered apex | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Osseotite Certain Prevail Implant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants |
| Region of Enrollment France | 16 participants |
| Region of Enrollment Germany | 13 participants |
| Region of Enrollment Italy | 17 participants |
| Region of Enrollment Netherlands | 7 participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| other Total, other adverse events | 11 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
Primary
Patients With Implants Achieving Osseous Integration
Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.
Time frame: 1 year
Population: total number of patients enrolled in the study was used for primary outcome analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osseotite Certain Prevail Implant | Patients With Implants Achieving Osseous Integration | 59 participants |
Secondary
Crestal Bone Regression
Time frame: four years