Evaluation of NobelActive Implants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Nobel Biocare.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Nobel Biocare
ClinicalTrials.gov Identifier:
NCT01397617
First received: July 15, 2011
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to determine the survival rate, marginal bone resorption, soft tissue health and maintenance of the NobelActive Internal and External implants and to make comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.


Condition Intervention
Partial Edentulism
Complete Edentulism
Device: NobelActive Internal implant
Device: NobelActive External implant
Device: NobelReplace Tapered Groovy implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Nobel Biocare:

Primary Outcome Measures:
  • Difference in marginal bone remodeling between the study groups after 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Marginal bone remodelling is measured using intraoral radiographs of the implant site. Change in bone level on both side of the implant (mesial and distal) from implant insertion to 5 year follow-up is measured.


Secondary Outcome Measures:
  • Implant survival rate after 5-years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 177
Study Start Date: April 2006
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NobelActvie Internal Device: NobelActive Internal implant
Experimental: NobelActive External Device: NobelActive External implant
Active Comparator: NobelReplace Tapered Groovy Device: NobelReplace Tapered Groovy implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject should be in need of an implant supported fixed restoration
  • The subjects should have sufficient bone volume and density i.e. an osseous architecture in the planned implant placement region sufficient to receive implants with a diameter of 3.5 mm and a length of at least 10 mm.
  • The subject as well as the implant sites should fulfill criteria for immediate functional tem-porization within 24 h.
  • The implant sites should be healed and free from infection.

Exclusion Criteria:

  • Alcohol or drug abuse as noted in patient records or in patient history.
  • Health conditions, which do not permit the surgical procedure.
  • Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history.
  • The subject is not able to give her/his informed consent to participate.
  • The need of bone augmentation before implant installation to obtain a prosthetically correct implantation transversally. However, a minor augmentation procedure to cover exposed threads or interproximal / buccal grafting due to deficient sites is not an exclusion criteria.
  • Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
  • Uncontrolled diabetics will be excluded.
  • Severe bruxism or other destructive habits.
  • Immediate insertion (e.g. placement of the implant immediately after extraction) consti-tutes an exclusion criterion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Nobel Biocare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Research Manager, nobel Biocare
ClinicalTrials.gov Identifier: NCT01397617     History of Changes
Other Study ID Numbers: T-117
Study First Received: July 15, 2011
Last Updated: July 18, 2011
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Germany: Ethics Commission
Israel: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee
Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on October 21, 2014