N/A
N=177
Randomized, Open Investigation Evaluating the Efficacy of Nobel Biocare SFB and CFB Implants
Partial Edentulism · Complete Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT01397617 ↗Enrolled (actual)
177
Serious AEs
6.4%
Results posted
Apr 2016
Primary outcome: Primary: 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). — -0.31; -0.98; -1.13; -0.16 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NobelActive Internal implant (Device); NobelActive External implant (Device); NobelReplace Tapered Groovy implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nobel Biocare
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
-0.31; -0.98; -1.13; -0.16; -0.89; -0.85 | — |
| SECONDARY Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). |
94.6; 96.3; 96.6; 95.7; 96.3; 96.6 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01397617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.