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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: August 18, 2014
Last verified: August 2014

October 24, 2008
August 18, 2014
September 2008
April 2012   (final data collection date for primary outcome measure)
  • Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
  • Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
  • Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
effectiveness - treatment difference in mean change in crestal bone level [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00780273 on ClinicalTrials.gov Archive Site
Not Provided
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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
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Anterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Edentulism
  • Device: Ankylos Implants
    ANKYLOS Implant System vs Certain PREVAIL Implant
  • Device: Biomet 3i Prevail Implants
  • 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.

    A total number of 19 subjects participated in this randomized, split mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who recieved 3 implants on each side which were splinted for the delivery of a fixed prosthesis.

    Intervention: Device: Ankylos Implants
  • 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.

    After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of the 2 parallel treatment groups: one side received ANKYLOS plus implants. The contralateral sde recieved Certain PREVAIL Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.

    Intervention: Device: Biomet 3i Prevail Implants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00780273
DF 245
No
Dentsply International
Dentsply International
Not Provided
Principal Investigator: George Romanos, DDS University of Rochester
Dentsply International
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP