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

Evaluation of NobelBiocare SFB and CFB Implants

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.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism; Complete Edentulism
• Intervention / Treatment: Device: NobelActive Internal implant; Device: NobelActive External implant; Device: NobelReplace Tapered Groovy implant

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 .

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NobelActive Internal; NobelActive Internal implant	Device: NobelActive Internal implant; Dental implant
Experimental: NobelActive External; NobelActive External implant	Device: NobelActive External implant; Dental implant
Active Comparator: NobelReplace Tapered Groovy; NobelReplace Tapered Groovy implant	Device: NobelReplace Tapered Groovy implant; Dental implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).	An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).	baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months

Collaborators and Investigators

• Sponsor: Nobel Biocare

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 15, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: T-117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No