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

Nobel Biocare

Status: Completed

Conditions: Partial Edentulism; Complete Edentulism

Treatments: Device: NobelActive External implant; Device: NobelReplace Tapered Groovy implant; Device: NobelActive Internal implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01397617

T-117

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 3 patient groups

NobelActive Internal

Experimental group

Description:

NobelActive Internal implant

Treatment:

Device: NobelActive Internal implant

NobelActive External

Experimental group

Description:

NobelActive External implant

Treatment:

Device: NobelActive External implant

NobelReplace Tapered Groovy

Active Comparator group

Description:

NobelReplace Tapered Groovy implant

Treatment:

Device: NobelReplace Tapered Groovy implant