Randomized, Open Investigation Evaluating the Efficacy of Nobel Biocare SFB and CFB Implants
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.
Device: NobelActive Internal implant
Device: NobelActive External implant
Device: NobelReplace Tapered Groovy implant
|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|
- 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.
- Implant survival rate after 5-years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2006|
|Study Completion Date:||September 2014|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: NobelActvie Internal
NobelActive Internal implant
|Device: NobelActive Internal implant|
Experimental: NobelActive External
NobelActive External implant
|Device: NobelActive External implant|
Active Comparator: NobelReplace Tapered Groovy
NobelReplace Tapered Groovy implant
|Device: NobelReplace Tapered Groovy implant|
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.
- survival rates,
- marginal bone resorption with marginal bone levels measurement,
- soft tissue health and maintenance via gingival index measurement, plaque index, papilla index .
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