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.
Information provided by (Responsible Party):
Dentsply International Identifier:
First received: October 24, 2008
Last updated: October 5, 2012
Last verified: October 2012

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

Condition Intervention Phase
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


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

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
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Please refer to this study by its identifier: NCT00780273

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

No publications provided

Responsible Party: Dentsply International 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 processed this record on July 29, 2014