Clinical trial NCT01397617: Randomized, Open Investigation Evaluating the Efficacy of Nobel Biocare SFB and CFB Implants
Official title: Evaluation of NobelBiocare SFB and CFB Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Complete Edentulism
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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).
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months
Secondary outcomes:
measure: Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months
Other outcomes:
Locations:
Study officials:
References:
citation: Arnhart C, Kielbassa AM, Martinez-de Fuentes R, Goldstein M, Jackowski J, Lorenzoni M, Maiorana C, Mericske-Stern R, Pozzi A, Rompen E, Sanz M, Strub JR. Comparison of variable-thread tapered implant designs to a standard tapered implant design after immediate loading. A 3-year multicentre randomised controlled trial. Eur J Oral Implantol. 2012 Summer;5(2):123-36.