Partial EdentulismNCT01397617

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

A study testing NobelActive Internal implant, NobelActive External implant and NobelReplace Tapered Groovy implant in people with Partial Edentulism and Complete Edentulism, run by Nobel Biocare.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Partial Edentulism, Complete Edentulism
What is being tested?: NobelActive Internal implant, NobelActive External implant and NobelReplace Tapered Groovy implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 177 participants
Where: No sites listed yet
Study dates: Apr 2006to May 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

About this study

Official title: Evaluation of NobelBiocare SFB and CFB Implants

Read the 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
Being tested: NobelActive Internal implant, NobelActive External implant, NobelReplace Tapered Groovy implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NobelActive Internal implantDevice
Dental implant
NobelActive External implantDevice
Dental implant
NobelReplace Tapered Groovy implantDevice
Dental implant

Study groups in NCT01397617
Study group	Role	What they receive
NobelActive Internal	Experimental	NobelActive Internal implant Receives: Device: NobelActive Internal implant
NobelActive External	Experimental	NobelActive External implant Receives: Device: NobelActive External implant
NobelReplace Tapered Groovy	Active comparator	NobelReplace Tapered Groovy implant Receives: Device: NobelReplace Tapered Groovy implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
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).
Measured: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006May 2013

First posted19 Jul 2011 (estimated)
Study startApr 2006
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Partial EdentulismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01397617
Sponsor's protocol ID: T-117
Status last verified: Mar 2016
First submitted: 15 Jul 2011
Last updated: 22 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 22866289

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
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All Partial Edentulism trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of NobelBiocare SFB and CFB Implants
ClinicalTrials.gov ID: NCT01397617
Acronym / sponsor ID: T-117
Conditions: Partial Edentulism, Complete Edentulism
Study type: Interventional
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: Nobel BiocareIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 19 Jul 2011 (estimated)
Results: Posted 22 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
NobelActive Internal	Experimental	Device: NobelActive Internal implantNobelActive Internal implant
NobelActive External	Experimental	Device: NobelActive External implantNobelActive External implant
NobelReplace Tapered Groovy	Active comparator	Device: NobelReplace Tapered Groovy implantNobelReplace Tapered Groovy implant

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NobelActive Internal implantDental implant	Device	NobelActive Internal
NobelActive External implantDental implant	Device	NobelActive External
NobelReplace Tapered Groovy implantDental implant	Device	NobelReplace Tapered Groovy

Primary outcome

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).
Time frame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months 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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 22 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NobelActive Internal	64	33
NobelActive External	53	30
NobelReplace Tapered Groovy	60	31

Primary outcome: 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).

Time frame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months. Mean (Standard Deviation). Unit: mm

Measure	NobelActive External n = 53	NobelActive Internal n = 64	NobelReplace Tapered Groovy n = 60
implant insertion to 60 months	-0.31 (1.50)	-0.98 (1.60)	-1.13 (1.67)
implant insertion to 36 months	-0.16 (1.06)	-0.89 (1.65)	-0.85 (1.32)
implant insertion to 24 months	-0.35 (0.83)	-0.68 (1.35)	-0.96 (1.25)
implant insertion to 12 months	-0.64 (0.97)	-0.95 (1.37)	-0.63 (1.17)
implant insertion to 6 months	-0.92 (0.96)	-1.03 (1.36)	-0.75 (1.13)
implant insertion to 3 months	-0.95 (1.03)	-0.96 (1.15)	-0.86 (0.99)

Population analysed: Intent to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were recorded during the duration of the study with the 5-year follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NobelActive External	2 of 30 (6.7%)	0 of 30 (0%)	Not reported
NobelActive Internal	1 of 33 (3%)	0 of 33 (0%)	Not reported
NobelReplace Tapered Groovy	3 of 31 (9.7%)	0 of 31 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22866289Arnhart 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.
Individual participant dataSharing planned: No

Related trials for Partial Edentulism

Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing NobelActive Internal implant, NobelActive External implant and NobelReplace Tapered Groovy implant in people with Partial Edentulism and Complete Edentulism, run by Nobel Biocare.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01397617, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.