Jaw, Edentulous, PartiallyNCT00646113
Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw
A study testing OsseoSpeed™ TX 3.0S in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 6 sites in 6 countries.
Trial summary
To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- OsseoSpeed™ TX 3.0S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Mar 2008to Aug 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Aged 18-70 years at enrolment
- History of edentulism in the study area of at least two months
- Presence of natural tooth roots adjacent to the study implant position
- Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
- Deemed by the investigator as likely to present an initially stable implant situation
Who cannot join
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathologic 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 could compromise post-operative healing and/or osseointegration, as deemed by the investigator
Show all 13Show fewer
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes per day
- Present alcohol and/or drug abuse
- 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 weeks prior to enrolment
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Spain1 site
Department Oral Surgery, University of Granada: School of Dentistry
Granada, 18071
Sweden1 site
Käkkirurgiska kliniken, Odontologiska Institutionen
Jönköping, 551 11
United Kingdom1 site
Bristol Dental Hospital and School
Bristol, BS1 2LY
About this study
Official title: An Open, Prospective, Single Arm, Multi-centre Study Evaluating OsseoSpeed™ Implant 3 mm Diameter Replacing a Central or Lateral Mandibular Incisor or Lateral Maxillary Incisor. A 5-year Follow-up Study.
To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- OsseoSpeed™ TX 3.0S
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoSpeed™ TX 3.0SDevice
OsseoSpeed™ TX 3.0 mm diameter
| Study group | Role | What they receive |
|---|---|---|
| OsseoSpeed™ TX 3.0S (Dental implant) | Experimental | OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm Receives: Device: OsseoSpeed™ TX 3.0S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival Rate
Overall implant survival rate evaluated clinically and radiographically
Measured: Evaluated at implant placement and at the 5 years follow-up after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2014
- Study completionAug 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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Galindo Moreno, Assoc. Prof., Principal investigator, University of Granada: School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646113
- Sponsor's protocol ID
- YA-NAR-0001
- Status last verified
- Nov 2019
- First submitted
- 25 Mar 2008
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Galindo-Moreno P, Nilsson P, King P, Becktor J, Speroni S, Schramm A, Maiorana C. Clinical and radiographic evaluation of early loaded narrow diameter implants - 1-year follow-up. Clin Oral Implants Res. 2012 May;23(5):609-16. doi: 10.1111/j.1600-0501.2011.02254.x. Epub 2011 Sep 28.
PubMed 22093047Maiorana C, King P, Quaas S, Sondell K, Worsaae N, Galindo-Moreno P. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 3 years follow-up. Clin Oral Implants Res. 2015;26(1):77-82. doi: 10.1111/clr.12281. Epub 2013 Oct 30.
PubMed 25650268King P, Maiorana C, Luthardt RG, Sondell K, Oland J, Galindo-Moreno P, Nilsson P. Clinical and Radiographic Evaluation of a Small-Diameter Dental Implant Used for the Restoration of Patients with Permanent Tooth Agenesis (Hypodontia) in the Maxillary Lateral Incisor and Mandibular Incisor Regions: A 36-Month Follow-Up. Int J Prosthodont. 2016 Mar-Apr;29(2):147-53. doi: 10.11607/ijp.4444.
PubMed 26929953Galindo-Moreno P, Nilsson P, King P, Worsaae N, Schramm A, Padial-Molina M, Maiorana C. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 5-year follow-up of a multicenter prospective clinical study. Clin Oral Implants Res. 2017 Dec;28(12):1584-1591. doi: 10.1111/clr.13029. Epub 2017 Jun 18.
PubMed 28626888
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Single Arm, Multi-centre Study Evaluating OsseoSpeed™ Implant 3 mm Diameter Replacing a Central or Lateral Mandibular Incisor or Lateral Maxillary Incisor. A 5-year Follow-up Study.
- ClinicalTrials.gov ID
- NCT00646113
- Acronym / sponsor ID
- YA-NAR-0001
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Mar 2008 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OsseoSpeed™ TX 3.0S (Dental implant) | Experimental | Device: OsseoSpeed™ TX 3.0SOsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of informed consent
- Aged 18-70 years at enrolment
- History of edentulism in the study area of at least two months
- Presence of natural tooth roots adjacent to the study implant position
- Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
Key exclusion criteria (13 listed)
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathologic 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™ TX 3.0SOsseoSpeed™ TX 3.0 mm diameter | Device | OsseoSpeed™ TX 3.0S (Dental implant) |
Primary outcome
Implant Survival Rate
Time frame: Evaluated at implant placement and at the 5 years follow-up after implant placement
Overall implant survival rate evaluated clinically and radiographically
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22093047Galindo-Moreno P, Nilsson P, King P, Becktor J, Speroni S, Schramm A, Maiorana C. Clinical and radiographic evaluation of early loaded narrow diameter implants - 1-year follow-up. Clin Oral Implants Res. 2012 May;23(5):609-16. doi: 10.1111/j.1600-0501.2011.02254.x. Epub 2011 Sep 28.
- Results publication: PubMed 25650268Maiorana C, King P, Quaas S, Sondell K, Worsaae N, Galindo-Moreno P. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 3 years follow-up. Clin Oral Implants Res. 2015;26(1):77-82. doi: 10.1111/clr.12281. Epub 2013 Oct 30.
- Results publication: PubMed 26929953King P, Maiorana C, Luthardt RG, Sondell K, Oland J, Galindo-Moreno P, Nilsson P. Clinical and Radiographic Evaluation of a Small-Diameter Dental Implant Used for the Restoration of Patients with Permanent Tooth Agenesis (Hypodontia) in the Maxillary Lateral Incisor and Mandibular Incisor Regions: A 36-Month Follow-Up. Int J Prosthodont. 2016 Mar-Apr;29(2):147-53. doi: 10.11607/ijp.4444.
- Results publication: PubMed 28626888Galindo-Moreno P, Nilsson P, King P, Worsaae N, Schramm A, Padial-Molina M, Maiorana C. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 5-year follow-up of a multicenter prospective clinical study. Clin Oral Implants Res. 2017 Dec;28(12):1584-1591. doi: 10.1111/clr.13029. Epub 2017 Jun 18.
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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.
Pablo Galindo Moreno, Assoc. Prof. principal investigator
University of Granada: School of Dentistry
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoSpeed™ TX 3.0S in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 6 sites in 6 countries.
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 6 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Germany, Italy, Spain, Sweden and 1 more country. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2019). 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?
Implant Survival Rate (time frame: Evaluated at implant placement and at the 5 years follow-up after implant placement). 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 NCT00646113, which also lists 4 linked publications.
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 18 Nov 2019.