Jaw, Edentulous, PartiallyNCT00710944
Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges
A study testing ASTRA TECH Implant System, OsseoSpeed™ in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 4 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- ASTRA TECH Implant System, OsseoSpeed™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2005to Nov 2012
- 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
- Provision of written informed consent
- 18 years of age and over
- A minimum of 20 stable intra occlusal contacts after planned restoration
- In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25
Who cannot join
- Untreated rampant caries and uncontrolled periodontal disease
- Use of smoking tobacco at time of inclusion
- History of pre-surgical bone augmentation, within 4 months, in the planned implant area
- History of extraction without augmentation, within 3 months in the planned implant area
- Absence of opposing dentition
- Absence of adjacent (mesial and/or distal) natural tooth
Show all 15Show fewer
- Uncontrolled diabetes
- Known pregnancy at time of inclusion
- Present alcohol or drug abuse
- Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Unable or unwilling to return for follow-up visits for a period of 5 years
- Unrealistic esthetical demands
- Unlikely to be able to comply with study procedures according to Investigators judgment
- Already included in this study
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
School of Dentistry
Chapel Hill, North Carolina, 27599-7450
Germany1 site
Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel
Kiel, 241 05
Spain1 site
Universitat Internacional de Catalunya, Department de Odontología
Barcelona, 08190
About this study
Official title: An Open, Prospective, Controlled Study in the Maxilla to Evaluate Clinical Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants in Single Tooth Replacement Using an Immediate Loading Protocol in Extraction Sockets and Healed Ridges.
The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- ASTRA TECH Implant System, OsseoSpeed™
- Keywords
- Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))
- Medical subject headings
- Jaw, Edentulous, Partially, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTRA TECH Implant System, OsseoSpeed™Device
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
| Study group | Role | What they receive |
|---|---|---|
| Extraction Sockets | Experimental | Immediate loading in extraction sockets. Receives: Device: ASTRA TECH Implant System, OsseoSpeed™ |
| Healed Ridges | Experimental | Immediate loading in healed ridges. Receives: Device: ASTRA TECH Implant System, OsseoSpeed™ |
| Grafted Sites | Experimental | Immediate loading of implants placed in grafted sites (four months healing after grafting). Receives: Device: ASTRA TECH Implant System, OsseoSpeed™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Measured: 12 months 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 posted8 Jul 2008 (estimated)
- Study startApr 2005
- Primary completionJun 2008
- Study completionNov 2012
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Cooper, Prof, DDS, PhD, Principal investigator, School of Dentistry, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710944
- Sponsor's protocol ID
- YA-OSS-0006
- Status last verified
- Jun 2014
- First submitted
- 7 Jul 2008
- Last updated
- 11 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cooper LF, Raes F, Reside GJ, Garriga JS, Tarrida LG, Wiltfang J, Kern M, de Bruyn H. Comparison of radiographic and clinical outcomes following immediate provisionalization of single-tooth dental implants placed in healed alveolar ridges and extraction sockets. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1222-32.
PubMed 21197501Raes F, Cooper LF, Tarrida LG, Vandromme H, De Bruyn H. A case-control study assessing oral-health-related quality of life after immediately loaded single implants in healed alveolar ridges or extraction sockets. Clin Oral Implants Res. 2012 May;23(5):602-8. doi: 10.1111/j.1600-0501.2011.02178.x. Epub 2011 Apr 19.
PubMed 21504481De Bruyn H, Raes F, Cooper LF, Reside G, Garriga JS, Tarrida LG, Wiltfang J, Kern M. Three-years clinical outcome of immediate provisionalization of single Osseospeed() implants in extraction sockets and healed ridges. Clin Oral Implants Res. 2013 Feb;24(2):217-23. doi: 10.1111/j.1600-0501.2012.02449.x. Epub 2012 Apr 2.
PubMed 22469026Cooper LF, Reside GJ, Raes F, Garriga JS, Tarrida LG, Wiltfang J, Kern M, De Bruyn H. Immediate provisionalization of dental implants placed in healed alveolar ridges and extraction sockets: a 5-year prospective evaluation. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):709-17. doi: 10.11607/jomi.3617.
PubMed 24818212
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Controlled Study in the Maxilla to Evaluate Clinical Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants in Single Tooth Replacement Using an Immediate Loading Protocol in Extraction Sockets and Healed Ridges.
- ClinicalTrials.gov ID
- NCT00710944
- Acronym / sponsor ID
- YA-OSS-0006
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 22 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extraction Sockets | Experimental | Device: ASTRA TECH Implant System, OsseoSpeed™Immediate loading in extraction sockets. |
| Healed Ridges | Experimental | Device: ASTRA TECH Implant System, OsseoSpeed™Immediate loading in healed ridges. |
| Grafted Sites | Experimental | Device: ASTRA TECH Implant System, OsseoSpeed™Immediate loading of implants placed in grafted sites (four months healing after grafting). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of written informed consent
- 18 years of age and over
- A minimum of 20 stable intra occlusal contacts after planned restoration
- In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25
Key exclusion criteria (15 listed)
- Untreated rampant caries and uncontrolled periodontal disease
- Use of smoking tobacco at time of inclusion
- History of pre-surgical bone augmentation, within 4 months, in the planned implant area
- History of extraction without augmentation, within 3 months in the planned implant area
- Absence of opposing dentition
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 |
|---|---|---|
| ASTRA TECH Implant System, OsseoSpeed™ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. | Device | Extraction Sockets, Grafted Sites, Healed Ridges |
Primary outcome
Implant Survival
Time frame: 12 months after implant placement
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21197501Cooper LF, Raes F, Reside GJ, Garriga JS, Tarrida LG, Wiltfang J, Kern M, de Bruyn H. Comparison of radiographic and clinical outcomes following immediate provisionalization of single-tooth dental implants placed in healed alveolar ridges and extraction sockets. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1222-32.
- Results publication: PubMed 21504481Raes F, Cooper LF, Tarrida LG, Vandromme H, De Bruyn H. A case-control study assessing oral-health-related quality of life after immediately loaded single implants in healed alveolar ridges or extraction sockets. Clin Oral Implants Res. 2012 May;23(5):602-8. doi: 10.1111/j.1600-0501.2011.02178.x. Epub 2011 Apr 19.
- Results publication: PubMed 22469026De Bruyn H, Raes F, Cooper LF, Reside G, Garriga JS, Tarrida LG, Wiltfang J, Kern M. Three-years clinical outcome of immediate provisionalization of single Osseospeed() implants in extraction sockets and healed ridges. Clin Oral Implants Res. 2013 Feb;24(2):217-23. doi: 10.1111/j.1600-0501.2012.02449.x. Epub 2012 Apr 2.
- Results publication: PubMed 24818212Cooper LF, Reside GJ, Raes F, Garriga JS, Tarrida LG, Wiltfang J, Kern M, De Bruyn H. Immediate provisionalization of dental implants placed in healed alveolar ridges and extraction sockets: a 5-year prospective evaluation. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):709-17. doi: 10.11607/jomi.3617.
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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.
Lyndon Cooper, Prof, DDS, PhD principal investigator
School of Dentistry, Chapel Hill
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASTRA TECH Implant System, OsseoSpeed™ in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 4 sites in 4 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 4 inclusion and 15 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 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium, Germany, Spain. 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 22 May 2014). 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 (time frame: 12 months 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 NCT00710944, 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 11 Jul 2014.