Clinical trial NCT00728962: A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.
Official title: A Prospective, Observational Study of Osseotite Certain IOL (Immediate Occlusal Loading) Implants in Immediate Occlusal Loading of Short Span Fixed Restorations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Edentulism
Tooth Disease
Keywords: dental implants
Osseotite Certain Prevail
multicenter
observational
clinical study
partial edentulism
single stage
immediate occlusal loading
crestal bone level
short fixed bridge
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2008-08-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These will be patients who are otherwise seeking dental implant therapy and belong to the study centers' standard patient population.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patients With Implants Achieving Osseous Integration
timeFrame: 1 year
Secondary outcomes:
measure: Crestal Bone Regression
timeFrame: four years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Hessam Nowzari, DDS
role: PRINCIPAL_INVESTIGATOR
References: