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

NCT01397617 | Completed Results

• 1 other identifier: T-117
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Partial Edentulism; Complete Edentulism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).

  baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months

Study Arms (3)

NobelActive Internal

EXPERIMENTAL

NobelActive Internal implant

Device: NobelActive Internal implant

NobelActive External

EXPERIMENTAL

NobelActive External implant

Device: NobelActive External implant

NobelReplace Tapered Groovy

ACTIVE COMPARATOR

NobelReplace Tapered Groovy implant

Device: NobelReplace Tapered Groovy implant

Interventions

NobelActive Internal implant DEVICE

Dental implant

NobelActive Internal

NobelActive External implant DEVICE

Dental implant

NobelActive External

NobelReplace Tapered Groovy implant DEVICE

Dental implant

NobelReplace Tapered Groovy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nobel Biocare: lead

Related Publications (1)

• 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.

  PMID: 22866289 DERIVED

Results Point of Contact

• Title: Head Clinical Trial Management
• Organization: Nobel Biocare Services AG

isabelle.arrighi@nobelbiocare.com

+41 43 211 42 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 19, 2011
• Study Start: April 1, 2006
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 22, 2016
• Results First Posted: April 22, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share