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 evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design 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 similar but non-lateralized Osseotite Certain implants.
Detailed description
This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.
Interventions
DEVICEOsseotite Certain Prevail
Root form titanium dental implant
DEVICEOsseotite Certain
Dental implant without the lateralized design
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 dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are 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 visit
Exclusion criteria
* patients with active infection or severe inflammation in the areas intended for the implants * patients with more than 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 * 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 | 4 years |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORAnton Friedmann, DMD
Charite- Zentrum fur Zahnmedizin
Participant flow
Recruitment details
A minimum of 100 patients were enrolled across all participating centers, with enrollment beginning in January 2005. Enrollment period remained open until April 2006. Three participating sites were Universities and seven 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 | 52 |
| Osseotite Certain Implant Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion | 50 |
| Total | 102 |
Baseline characteristics
| Characteristic | Osseotite Certain Prevail Implant | Osseotite Certain Implant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 38 Participants | 78 Participants |
| Region of Enrollment France | 6 participants | 5 participants | 11 participants |
| Region of Enrollment Germany | 8 participants | 8 participants | 16 participants |
| Region of Enrollment Italy | 19 participants | 17 participants | 36 participants |
| Region of Enrollment Sweden | 5 participants | 4 participants | 9 participants |
| Region of Enrollment United States | 14 participants | 16 participants | 30 participants |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Male | 31 Participants | 31 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 4 / 52 | 19 / 50 |
| serious Total, serious adverse events | 0 / 52 | 0 / 50 |
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 represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osseotite Certain Prevail Implant | Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit | -0.7705 millimeters | Standard Error 0.1567 |
| Osseotite Certain Implant | Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit | -0.6648 millimeters | Standard Error 0.1158 |
Secondary
Osseous Integration
Time frame: 4 years