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

Partial Edentulism Clinical Trial

Official title:

Evaluation of NobelBiocare SFB and CFB Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397617
• Other study ID #: T-117
• Status: Completed
• Phase: N/A
• First received: July 15, 2011
• Last updated: April 28, 2015
• Start date: April 2006
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Nobel Biocare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Ethics CommitteeGermany: Ethics CommissionIsrael: Ethics CommissionItaly: Ethics CommitteeSpain: Ethics CommitteeSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: September 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complete Edentulism
• Partial Edentulism

Intervention

Device:
• NobelActive Internal implant

• NobelActive External implant

• NobelReplace Tapered Groovy implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nobel Biocare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in marginal bone remodeling between the study groups after 5 years	Marginal bone remodelling is measured using intraoral radiographs of the implant site. Change in bone level on both side of the implant (mesial and distal) from implant insertion to 5 year follow-up is measured.	5 years	No
Secondary	Implant survival rate after 5-years		5 years	Yes