Randomized, Open Investigation Evaluating the Efficacy of Nobel Biocare SFB and CFB Implants
|ClinicalTrials.gov Identifier: NCT01397617|
Recruitment Status : Completed
First Posted : July 19, 2011
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Partial Edentulism Complete Edentulism||Device: NobelActive Internal implant Device: NobelActive External implant Device: NobelReplace Tapered Groovy implant||Not Applicable|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||177 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of NobelBiocare SFB and CFB Implants|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Experimental: NobelActive 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 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 ]
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.
- 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 ]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).