Partial EdentulismNCT02180230

Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use

A study testing Shorty implants 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.

Trial summary

The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Partial Edentulism, Complete Edentulism
What is being tested?: Shorty implants
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: No sites listed yet
Study dates: Oct 2007to Dec 2014
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm.
The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm.
The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization.
Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion.
The implants site(s) should be free from extraction remnants.
The subject should be healthy and compliant with good oral hygiene.
The subject should be available for the 5-year term of the investigation.
Favorable and stable occlusal relationship

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.
Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
Severe bruxism or other destructive habits.

About this study

Read the detailed description

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, 36 and 60 months).

Further endpoints were:

cumulative survival rates of the implants
soft tissue parameters (papilla index, bleeding on probing)
plaque formation

Conditions: Partial Edentulism, Complete Edentulism
Being tested: Shorty implants
Keywords: Short implants, prospective multicenter study, maxilla & mandible

What participants receive

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

Shorty implantsDevice
Also called Brånemark System Mk III Shorty and/or NobelSpeedy Shorty
Dental implant insertion to maxilla or mandible

Study groups in NCT02180230
Study group	Role	What they receive
Shorty implants	Other	Brånemark System Mk III Shorty and/or NobelSpeedy Shorty Receives: Device: Shorty implants

What is being measured

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

Marginal Bone Remodeling
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: from implant insertion to 6, 12, 36 and 60 months

Secondary outcomes (1)

Cumulative Survival Rates of the Implants
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: implant insertion to follow-up visits (6, 12, 36 and 60 months)

Timeline

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

Oct 2007Dec 2014

First posted2 Jul 2014 (estimated)
Study startOct 2007
Primary completionDec 2014
Study completionDec 2014

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02180230
Sponsor's protocol ID: T-127
Status last verified: Dec 2015
First submitted: 26 Jun 2014
Last updated: 22 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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

Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
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Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
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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
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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: Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use
ClinicalTrials.gov ID: NCT02180230
Acronym / sponsor ID: T-127
Conditions: Partial Edentulism, Complete Edentulism
Keywords: Short implants, prospective multicenter study, maxilla & mandible
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Nobel BiocareIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 2 Jul 2014 (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

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, 36 and 60 months).

Further endpoints were:

cumulative survival rates of the implants
soft tissue parameters (papilla index, bleeding on probing)
plaque formation

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Shorty implants	Other	Device: Shorty implantsBrånemark System Mk III Shorty and/or NobelSpeedy Shorty

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

The subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm.
The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm.
The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization.
Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion.
The implants site(s) should be free from extraction remnants.

Key exclusion criteria (6 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.
Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.

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
Shorty implantsAlso: Brånemark System Mk III Shorty and/or NobelSpeedy ShortyDental implant insertion to maxilla or mandible	Device	Shorty implants

Primary outcome

Marginal Bone Remodeling
Time frame: from implant insertion to 6, 12, 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.

1 secondary outcome

Cumulative Survival Rates of the Implants
Time frame: implant insertion to follow-up visits (6, 12, 36 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
Shorty Implants	38	31

Primary outcome: Marginal Bone Remodeling

Time frame: from implant insertion to 6, 12, 36 and 60 months. Mean (Standard Deviation). Unit: mm

Measure	Shorty Implants n = 38
implant insertion to 6 months	-1.34 (1.10)
implant insertion to 12 months	-1.38 (1.12)
implant insertion to 36 months	-1.37 (1.02)
implant insertion to 60 months	-1.65 (1.11)

Population analysed: Intention 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 collected during the course of the study up to 5-years follow up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Shorty Implants	0 of 38 (0%)	9 of 38 (23.7%)	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.
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 Shorty implants 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 8 inclusion and 6 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?

Marginal Bone Remodeling (time frame: from implant insertion to 6, 12, 36 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 NCT02180230.

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.