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

NCT ID: NCT01397617

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2013-05-31

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 .

Conditions

Partial Edentulism; Complete Edentulism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NobelActive Internal

NobelActive Internal implant

Group Type: EXPERIMENTAL

NobelActive Internal implant

Intervention Type: DEVICE

Dental implant

NobelActive External

NobelActive External implant

Group Type: EXPERIMENTAL

NobelActive External implant

Intervention Type: DEVICE

Dental implant

NobelReplace Tapered Groovy

NobelReplace Tapered Groovy implant

Group Type: ACTIVE_COMPARATOR

NobelReplace Tapered Groovy implant

Intervention Type: DEVICE

Dental implant

Interventions

NobelActive Internal implant

Dental implant

Intervention Type: DEVICE

NobelActive External implant

Dental implant

Intervention Type: DEVICE

NobelReplace Tapered Groovy implant

Dental implant

Intervention Type: DEVICE

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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobel Biocare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 22866289 (View on PubMed)

Other Identifiers

T-117

Identifier Type: -

Identifier Source: org_study_id