PeriodontitisEarly Phase 1NCT00226148
Immediate Implant Placement in the Molar Regions
A Early Phase 1 study testing Use of a membrane to cover bonedefects around implant, Use of bonechips to fill up defects around implant and Use of membrane and bonechips to manage defects in people with Periodontitis and Dental Caries, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to look at the bonehealing when a molar has been extracted and immediately replaced by an implant leaving some defects around the implant. The defects are being treated in three different with the hypothesis that the three ways of treatment result in equal bonehealing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Dental Caries, Periapical Periodontitis
- What is being tested?
- Use of a membrane to cover bonedefects around implant, Use of bonechips to fill up defects around implant and Use of membrane and bonechips to manage defects
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 92 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2005to Sep 2009
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A molar tooth which has to be extracted
- Healthy persons with only mild systemic disease with no functional limitation
Who cannot join
- Pregnant
- Any disease that is influencing the turnover of bone or oral mucosa
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to look at the bonehealing when a molar has been extracted and immediately replaced by an implant leaving some defects around the implant.
The defects are being treated in three different with the hypothesis that the three ways of treatment result in equal bonehealing.
Read the detailed description
This study is a randomized clinically controlled study with three group of each thirty patients, where the bonehealing after immediate implantplacement in molarregions is being investigated.
Totally 90 patients are going to get a molar tooth extracted and immediately replaced with an implant (Brånemark System, Wide Platform). The molar tooth should be in such a condition that is has to be extracted.
Extracting a molar leaves a defect which cannot completely be filled out by an implant. The 90 patients are therefore randomised into 3 groups according to how the perimarginal bonedefects around the placed implants are being treated: 1. Bonechips 2. Membrane 3. Bonechips+Membrane. The bonehealing of the defects around the implants are then compared the groups in between. The amount of newly formed bone is being estimated too by digital radiography and subtractionradiography. Furthermore the prognosis for immediate placed implants in molar regions in relation to the method of defectreconstruction one year after crown delivery is also being investigated. All the investigations are conducted with the Ho-hypothesis that there is no difference in the bonehealing the three groups in between.
- Conditions
- Periodontitis, Dental Caries, Periapical Periodontitis
- Being tested
- Use of a membrane to cover bonedefects around implant, Use of bonechips to fill up defects around implant, Use of membrane and bonechips to manage defects
- Keywords
- Implant, Immediate placement, Molar tooth
- Medical subject headings
- Periodontitis, Dental Caries, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a membrane to cover bonedefects around implantProcedure or surgery
Use of bonechips to fill up defects around implantDevice
Use of membrane and bonechips to manage defectsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Digitial radiography of the implants at placement, 3 month, 6 month, at abutmentoperation, at crownplacement, 3 month after crownplacement and 6 month after crownplacement.
Measured: see above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2009
- Study completionSep 2009
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 PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council
- Investigators
- Ann Wenzel, Prof.Dr.Odont, Ph.d.,DDS, Study chair, The Royal Dental College of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226148
- Sponsor's protocol ID
- 2005/0091
- Other IDs
- 22-04-0281
- Status last verified
- Sep 2009
- First submitted
- 23 Sep 2005
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Urban T, Kostopoulos L, Wenzel A. Immediate implant placement in molar regions: a 12-month prospective, randomized follow-up study. Clin Oral Implants Res. 2012 Dec;23(12):1389-97. doi: 10.1111/j.1600-0501.2011.02319.x. Epub 2011 Nov 25.
PubMed 22117841
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement in the Molar Regions
- ClinicalTrials.gov ID
- NCT00226148
- Acronym / sponsor ID
- 2005/0091
- Conditions
- Periodontitis, Dental Caries, Periapical Periodontitis
- Keywords
- Implant, Immediate placement, Molar tooth
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Sep 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Sep 2005 (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.
The purpose of this study is to look at the bonehealing when a molar has been extracted and immediately replaced by an implant leaving some defects around the implant.
The defects are being treated in three different with the hypothesis that the three ways of treatment result in equal bonehealing.
Detailed description
This study is a randomized clinically controlled study with three group of each thirty patients, where the bonehealing after immediate implantplacement in molarregions is being investigated.
Totally 90 patients are going to get a molar tooth extracted and immediately replaced with an implant (Brånemark System, Wide Platform). The molar tooth should be in such a condition that is has to be extracted.
Extracting a molar leaves a defect which cannot completely be filled out by an implant. The 90 patients are therefore randomised into 3 groups according to how the perimarginal bonedefects around the placed implants are being treated: 1. Bonechips 2. Membrane 3. Bonechips+Membrane. The bonehealing of the defects around the implants are then compared the groups in between. The amount of newly formed bone is being estimated too by digital radiography and subtractionradiography. Furthermore the prognosis for immediate placed implants in molar regions in relation to the method of defectreconstruction one year after crown delivery is also being investigated. All the investigations are conducted with the Ho-hypothesis that there is no difference in the bonehealing the three groups in between.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A molar tooth which has to be extracted
- Healthy persons with only mild systemic disease with no functional limitation
Key exclusion criteria (2 listed)
- Pregnant
- Any disease that is influencing the turnover of bone or oral mucosa
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 |
|---|---|---|
| Use of a membrane to cover bonedefects around implant | Procedure or surgery | – |
| Use of bonechips to fill up defects around implant | Device | – |
| Use of membrane and bonechips to manage defects | Procedure or surgery | – |
Primary outcome
Digitial radiography of the implants at placement, 3 month, 6 month, at abutmentoperation, at crownplacement, 3 month after crownplacement and 6 month after crownplacement.
Time frame: see above
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 Sep 2009.
- Derived from this study: PubMed 22117841Urban T, Kostopoulos L, Wenzel A. Immediate implant placement in molar regions: a 12-month prospective, randomized follow-up study. Clin Oral Implants Res. 2012 Dec;23(12):1389-97. doi: 10.1111/j.1600-0501.2011.02319.x. Epub 2011 Nov 25.
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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.
Ann Wenzel, Prof.Dr.Odont, Ph.d.,DDS study chair
The Royal Dental College of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Use of a membrane to cover bonedefects around implant, Use of bonechips to fill up defects around implant and Use of membrane and bonechips to manage defects in people with Periodontitis and Dental Caries, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 2 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 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Digitial radiography of the implants at placement, 3 month, 6 month, at abutmentoperation, at crownplacement, 3 month after crownplacement and 6 month after crownplacement. (time frame: see above). 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 NCT00226148, 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 Sep 2009.