Clinical trial NCT00723944: A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases
Official title: A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implanting Short-span Fixed Bridge Cases for Preservation of Crestal Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Tooth Disease
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
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit
timeFrame: 1 year
Secondary outcomes:
measure: Osseous Integration
timeFrame: 4 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite- Universitatsmedizin Berlin
Study officials:
affiliation: Charite- Zentrum fur Zahnmedizin
name: Anton Friedmann, DMD
role: PRINCIPAL_INVESTIGATOR
References: