Partial Edentulism
Conditions
Keywords
dental implants, Certain Prevail, multicenter, clinical study, partial edentulism, total edentulism, platform switching, single stage, early loading, crestal bone level, single tooth replacements, short or long fixed bridges, overdenture, fixed denture
Brief summary
This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. It will also evaluate implant performance. Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls).
Detailed description
This is a prospective, observational study of patients with partial or complete edentulism treated with the Certain Prevail dental implants. Restorations will consist of single tooth replacements, short and long fixed bridges, and overdentures and full dentures. All implants are placed using a single stage approach and temporalization occurring after two months of healing (early loading). Each center will strive to enroll a total of 20 patients.
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 any race greater than 18 years of age * patients for whom a decision has already been made to use dental implants for treating an existing dental condition specifically: 1. dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture. 2. a temporary healing abutment will be placed on implant during implant placement surgery (single stage procedure). * patients must be physically able to tolerate conventional surgical and restorative procedures * patients must agree to be evaluated for each study visit, especially the yearly follow-up visit
Exclusion criteria
* patients with active infection or severe inflammation in the areas intended for implant placement * patients with a \>10 cigarette per day smoking habit * patients with uncontrolled diabetes mellitus * patients with metabolic bone disease * patients who have had treatment with therapeutic radiation to the head within the past 12 months * patients in need of allogenic bone grafting at the site of the intended study implant for augmentation purposes. Grafting for treatment of dehiscence or fenestration must have occurred at least 8 weeks prior to implant placement surgery * patients who are pregnant at the screening visit * patients with evidence of severe para-functional habits such as bruxing or clenching * patients with less than 6 weeks of healing time post tooth extraction at the intended treatment site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Osseous Integration | 2 years |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORMartin Lorenzoni, DMD, MD, PhD
MEDIZINISCHE UNIVERSITAT GRAZ
Participant flow
Recruitment details
161 patients were enrolled across all participating centers, with enrollment efforts beginning in September 6 2005 (first patient enrolled) and completing in January 22 2007 (last patient enrolled). Ten participating sites are private practices and two are Universities.
Pre-assignment details
Pre-treatment included a screening visit (enroll those meeting all inclusion criteria),signing informed consent, and per-surgical data collection. Patients are then scheduled for implant placement surgery.
Participants by arm
| Arm | Count |
|---|---|
| Certain Prevail Implants Osseotite surfaced implants with internal connection | 162 |
| Total | 162 |
Baseline characteristics
| Characteristic | Certain Prevail Implants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 135 Participants |
| Region of Enrollment Australia | 10 Participants |
| Region of Enrollment Austria | 26 Participants |
| Region of Enrollment France | 9 Participants |
| Region of Enrollment Ireland | 14 Participants |
| Region of Enrollment Italy | 52 Participants |
| Region of Enrollment Sweden | 20 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 99 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 161 |
| other Total, other adverse events | 7 / 161 |
| serious Total, serious adverse events | 0 / 161 |
Outcome results
Primary
Osseous Integration
Time frame: one year
Population: total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certain Prevail Implants | Osseous Integration | 145 participants |
Secondary
Crestal Bone Resorption
Crestal bone level measures- changes from baseline to last study visit
Time frame: four years