Partial Edentulism, Tooth Disease
Conditions
Keywords
dental implants, Osseotite Certain Prevail, Lateralized, non-lateralized, Osseotite Certain, multicenter, randomized, clinical study, partial edentulism, single stage, early loading, crestal bone level, short fixed bridge
Brief summary
This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version of the implant. Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for a similar but non-lateralized Osseotite Certain implant.
Detailed description
This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive either the Osseotite Certain Lateralized (test) or the Osseotite Certain Non-lateralized (control). All implants will receive a temporary prosthesis after two months of placement. Enrollment will include up to 20 patients (approximately 60 implants per center) at each participating study center.
Interventions
DEVICEDental implant Osseotite Prevail
Root form titanium dental implant
DEVICEDental implant Osseotite
root form titanium dental implant
Sponsors
ZimVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers allowed but one interior crown may be a pontic * 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 visits
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 a the site of the intended study implant * patients who are pregnant at the screening visit * patients with evidence of severe para-functional habits such as bruxing or clenching * patients with cantilevers and more than one pontic per bridge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit | 1 year | Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit. |
Secondary
| Measure | Time frame |
|---|---|
| Osseous Integration | four years |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHarold Baumgarten, DMD
University of Pennsylvania
Participant flow
Recruitment details
Up to 120 patients were enrolled across all centers, with enrollment efforts beginning in February 2005. Enrollment period remained open until June 2006. Two participating sites were Universities and four were private practices.
Pre-assignment details
Pre-treatment included a screening visit (enroll those meeting all inclusion criteria), signing informed consent, and pre-surgical data collection.Patients returned for implant placement surgery, followed by temporary prosthesis placement at 2 months.
Participants by arm
| Arm | Count |
|---|---|
| Osseotite Certain Prevail Implant Patients with dental implant with internal connection and expanded, lateralized design at coronal portion | 29 |
| Osseotite Certain Implant Patients with dental implant with internal connection and without the lateralized expanded platform design | 32 |
| Total | 61 |
Baseline characteristics
| Characteristic | Osseotite Certain Prevail Implant | Osseotite Certain Implant | Total |
|---|---|---|---|
| Age, Customized <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >=65 years | 11 participants | 11 participants | 22 participants |
| Age, Customized Between 18 and 65 years | 18 participants | 21 participants | 39 participants |
| Region of Enrollment Australia | 3 participants | 5 participants | 8 participants |
| Region of Enrollment Italy | 15 participants | 15 participants | 30 participants |
| Region of Enrollment Sweden | 5 participants | 4 participants | 9 participants |
| Region of Enrollment United States | 6 participants | 8 participants | 14 participants |
| Sex/Gender, Customized Female | 14 participants | 15 participants | 29 participants |
| Sex/Gender, Customized Male | 15 participants | 17 participants | 32 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 5 / 29 | 5 / 32 |
| serious Total, serious adverse events | 0 / 29 | 0 / 32 |
Outcome results
Primary
Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit
Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.
Time frame: 1 year
Population: population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osseotite Certain Prevail Implant | Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit | -0.7440 millimeters | Standard Error 0.1881 |
| Osseotite Certain Implant | Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit | -0.8445 millimeters | Standard Error 0.1439 |
Secondary
Osseous Integration
Time frame: four years