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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Evaluation of NobelBiocare SFB and CFB Implants

Conditions
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Partial Edentulism, Complete Edentulism

Intervention / Treatment
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* Device: NobelActive Internal implant
* Device: NobelActive External implant
* Device: NobelReplace Tapered Groovy implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NobelActive Internal<br>NobelActive Internal implant | Device: NobelActive Internal implant<br>* Dental implant<br>|
| Experimental: NobelActive External<br>NobelActive External implant | Device: NobelActive External implant<br>* Dental implant<br>|
| Active Comparator: NobelReplace Tapered Groovy<br>NobelReplace Tapered Groovy implant | Device: NobelReplace Tapered Groovy implant<br>* Dental implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 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). | baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months |