Partial EdentulismNCT01324778
Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed
A study testing OsseoSpeed TX and OsseoSpeed in people with Partial Edentulism and Edentulism Nos, run by Dentsply Sirona Implants and Consumables at 11 sites in Sweden.
Trial summary
To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism, Edentulism Nos
- What is being tested?
- OsseoSpeed TX and OsseoSpeed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 11 sitesSweden
- Study dates
- Mar 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Provision of informed consent
- Female/male aged 18 years and over
- History of edentulism in the study area of at least 3 months
- In need for implant(s) replacing missing tooth/teeth in the maxilla
- Deemed by the investigator to be suitable for one stage surgery
- Deemed by the investigator to be suitable for loading after 10-12 weeks
- Deemed by the investigator as likely to present an initially stable implant situation.
- Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.
Who cannot join
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathological processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
Show all 13Show fewer
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Present alcohol and/or drug abuse
- Current need for bone grafting and/or augmentation in the planned implant area
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrolment in the present study.
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Sweden11 sites
Specialisttandvården, Hallands sjukhus
Halmstad
Avd. för Parodontologi / Avd. för Oral Protetik, Odontologiska Institutionen
Jönköping
Specialist- och sjukhustandvården
Kalmar
Centrum för Oral Rehablilitering
Linköping, 581 85
Colossseumkliniken Mölndal
Mölndal, 431 30
Käkkirurgiska kliniken / Protetikkliniken
Örebro, 701 85
Käkcentrum, Södersjukhuset
Stockholm, 118 83
Specialisttandvården, S:t Eriks Sjukhus
Stockholm
Käkkirurgiska kliniken NÄL / Specialistcentrum Uddevalla sjukhus
Trollhättan, 431 85
Käkkirurgiska Kliniken/Protetikkliniken
Umeå, 901 87
Parodontologi kliniken och Protetik- och Bettfysiologiska kliniken
Vaxjo, 352 31
About this study
Official title: An Open, Randomized, Prospective Multi Centre Study Comparing OsseoSpeedTM TX With OsseoSpeedTM in the Partially and Totally Edentulous Maxillae
To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX
- Conditions
- Partial Edentulism, Edentulism Nos
- Being tested
- OsseoSpeed TX, OsseoSpeed
- Keywords
- Edentulism in the Upper Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoSpeed TXDevice
OsseoSpeedTM TX implants of lengths 6-17 mm
OsseoSpeedDevice
OsseoSpeedTM implants of lengths 6-17 mm
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: OsseoSpeed TX |
| B | Active comparator | Not described Receives: Device: OsseoSpeed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level
Marginal Bone Level will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Measured: One year after loading
Secondary outcomes (4)
Implant stability
Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
Measured: At implant placement (inclusion) (day 1)
Implant stability
Implant stability will be evaluated using Resonance Frequency Analysis (RFA)
Measured: At implant placement (inclusion) (day 1)
Implant stability
Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
Measured: At implant loading (10-12 weeks after implant placement)
Implant survival
Implant survival rate will be evaluated by clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.
Measured: One year after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl-Johan Ivanoff, DDS, PhD, Principal investigator, Colosseumkliniken Mölndal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324778
- Sponsor's protocol ID
- YA-OTX-0001
- Status last verified
- May 2017
- First submitted
- 22 Mar 2011
- Last updated
- 10 May 2017
- Results posted
- No
Publications
Ivanoff CJ, Lindhe J, Ellner S, Johansson KJ, Abrahamsson P. An open, randomised, multi-centre study, comparing straight and tapered apex implants design, in partially and totally edentulous maxillae. Acta Odontol Scand. 2021 Oct;79(7):492-498. doi: 10.1080/00016357.2021.1894352. Epub 2021 Mar 5.
PubMed 33666125
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Prospective Multi Centre Study Comparing OsseoSpeedTM TX With OsseoSpeedTM in the Partially and Totally Edentulous Maxillae
- ClinicalTrials.gov ID
- NCT01324778
- Acronym / sponsor ID
- YA-OTX-0001
- Conditions
- Partial Edentulism, Edentulism Nos
- Keywords
- Edentulism in the Upper Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: OsseoSpeed TX |
| B | Active comparator | Device: OsseoSpeed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of informed consent
- Female/male aged 18 years and over
- History of edentulism in the study area of at least 3 months
- In need for implant(s) replacing missing tooth/teeth in the maxilla
- Deemed by the investigator to be suitable for one stage surgery
Key exclusion criteria (13 listed)
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathological processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
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 |
|---|---|---|
| OsseoSpeed TXOsseoSpeedTM TX implants of lengths 6-17 mm | Device | A |
| OsseoSpeedOsseoSpeedTM implants of lengths 6-17 mm | Device | B |
Primary outcome
Marginal Bone Level
Time frame: One year after loading
Marginal Bone Level will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
4 secondary outcomes
Implant stability
Time frame: At implant placement (inclusion) (day 1)
Implant stability
Time frame: At implant placement (inclusion) (day 1)
Implant stability
Time frame: At implant loading (10-12 weeks after implant placement)
Implant survival
Time frame: One year after loading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Derived from this study: PubMed 33666125Ivanoff CJ, Lindhe J, Ellner S, Johansson KJ, Abrahamsson P. An open, randomised, multi-centre study, comparing straight and tapered apex implants design, in partially and totally edentulous maxillae. Acta Odontol Scand. 2021 Oct;79(7):492-498. doi: 10.1080/00016357.2021.1894352. Epub 2021 Mar 5.
Related trials for Partial Edentulism
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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.
Carl-Johan Ivanoff, DDS, PhD principal investigator
Colosseumkliniken Mölndal
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoSpeed TX and OsseoSpeed in people with Partial Edentulism and Edentulism Nos, run by Dentsply Sirona Implants and Consumables at 11 sites in Sweden.
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 13 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Level (time frame: One year after loading). 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 NCT01324778, 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 10 May 2017.