Randomized, Open Investigation Evaluating the Efficacy of Nobel Biocare SFB and CFB Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare
ClinicalTrials.gov Identifier:
NCT01397617
First received: July 15, 2011
Last updated: March 22, 2016
Last verified: March 2016
  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
Official Title: Evaluation of NobelBiocare SFB and CFB Implants

Further study details as provided by Nobel Biocare:

Primary Outcome Measures:
  • The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). [ Time Frame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months ] [ Designated as safety issue: No ]

    Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.

    Missing data was not imputed and not included in evaluation.



Secondary Outcome Measures:
  • Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). [ Time Frame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months ] [ Designated as safety issue: Yes ]
    An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).


Enrollment: 177
Study Start Date: April 2006
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NobelActive Internal
NobelActive Internal implant
Device: NobelActive Internal implant
Dental implant
Experimental: NobelActive External
NobelActive External implant
Device: NobelActive External implant
Dental implant
Active Comparator: NobelReplace Tapered Groovy
NobelReplace Tapered Groovy implant
Device: NobelReplace Tapered Groovy implant
Dental implant

Detailed Description:

The purpose of this study is to determine safety and efficacy parameters for the NobelActive Internal and External implants and to make comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.

Safety: AEs

Efficacy:

  • survival rates,
  • marginal bone resorption with marginal bone levels measurement,
  • soft tissue health and maintenance via gingival index measurement, plaque index, papilla index .
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT01397617     History of Changes
Other Study ID Numbers: T-117 
Study First Received: July 15, 2011
Results First Received: December 8, 2015
Last Updated: March 22, 2016
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Germany: Ethics Commission
Israel: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee
Switzerland: Ethikkommission
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on July 26, 2016