Clinical trial NCT00728884: Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible
Official title: Observational Study of Certain Prevail Implant System in Maxillary and Mandibular Regions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Edentulism
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
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2008-08-06
Enrollment: 162
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 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.

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:

  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

Primary outcomes:
measure: Osseous Integration
timeFrame: one year
Secondary outcomes:
measure: Crestal Bone Resorption
timeFrame: four years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde
Study officials:
affiliation: MEDIZINISCHE UNIVERSITAT GRAZ
name: Martin Lorenzoni, DMD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: