ClinicalTrials.Veeva

Menu

A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases. (Cliffhanger)

Z

ZimVie

Status

Completed

Conditions

Tooth Disease
Partial Edentulism

Treatments

Device: Dental implant Osseotite Prevail
Device: Dental implant Osseotite

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

61 participants in 2 patient groups

Dental implant Osseotite Prevail
Experimental group
Description:
Dental implant with lateralized design
Treatment:
Device: Dental implant Osseotite Prevail
Dental implant Osseotite
Active Comparator group
Description:
Dental implant without the lateralized design
Treatment:
Device: Dental implant Osseotite

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems