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Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply International
ClinicalTrials.gov Identifier:
NCT00780273
First received: October 24, 2008
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

Change in crestal bone level implants at 5% significance level.


Condition Intervention Phase
Edentulism
 Device: Ankylos Implants
Device: Biomet 3i Prevail Implants
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Naterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial

Further study details as provided by Dentsply International:

Primary Outcome Measures:
  • effectiveness - treatment difference in mean change in crestal bone level [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: September 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ankylos dental implants.
3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
 Device: Ankylos Implants
ANKYLOS Implant System vs Certain PREVAIL Implant
Active Comparator: 3i Prevail dental implants.
Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.
 Device: Biomet 3i Prevail Implants

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 to 80
  • male or female (female non-pregnant)
  • sufficient oral hygiene
  • no inflammation/disorder in the area of implant site
  • edentulous mandible and sufficient prosthetic and conservative
  • sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm
  • provide written informed consent

Exclusion Criteria:

  • demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
  • exhibit angulation requirements of restoration exceeding 15 degrees
  • systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
  • taking medication that would compromise post-operative healing and/or osseointegration
  • bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
  • oncology treatment
  • oral infection
  • acute gingivitis and/or periodontitis
  • local bone defects in the area of planned implantation
  • disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)
  • received investigational drug within 30 days
  • history of illicit drugs or alcohol abuse
  • history of addiction to medication
  • allergic to dental materials
  • nicotine abuse (> 20 cigarettes/day)
  • pregnant or nursing
  • clinical significant or unstable medical or physiological conditions that would compromise participation in study
  • unable or unwilling to return for follow-up visits for a period of 24 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780273

Locations
United States, New York
University of Rochester, Eastman Dept of Dentistry
Rochester, New York, United States, 14620
Sponsors and Collaborators
Dentsply International
Investigators
Principal Investigator: George Romanos, DDS University of Rochester
  More Information

No publications provided

Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT00780273     History of Changes
Other Study ID Numbers: DF 245
Study First Received: October 24, 2008
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dentsply International:
subjects with edentulous mandible

ClinicalTrials.gov processed this record on May 19, 2013