Edentatio (Toothlessness)Phase 2NCT00767169
Bisphosphonate-coated Dental Implants
A Phase 2 study testing Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate in people with Edentatio (Toothlessness), run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentatio (Toothlessness)
- What is being tested?
- Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to Jun 2011
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Need for at least 2 dental implants, which are to be inserted in bone of reasonably similar quality.
Who cannot join
- Systemic or immunologic disease, alcoholism, uncontrolled diabetes and smoking.
- Local exclusion criteria were: previous tumour, trauma and surgery.
- Also patients with Cawood \& Howell class IV - VI maxilla-bone were excluded.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Oral & maxillofacial surgery, University Hospital.
Linköping, SE-581 85
About this study
Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. The screws are compared by measuring how well fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the bisphosphonates will improve fixation.
- Conditions
- Edentatio (Toothlessness)
- Being tested
- Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate
- Keywords
- Edentatio (Toothlessness)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant coating with a fibrinogen carrier for pamidronate and ibandronateDevice
Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate compared with uncoated controls in the same mouth.
| Study group | Role | What they receive |
|---|---|---|
| coated implant and control | Experimental | Not described Receives: Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.
Measured: 6 months
Secondary outcomes (1)
Marginal resorption on x-rays
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJun 2011
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 Edentatio (Toothlessness)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Aspenberg, University Hospital, Linkoeping
- Investigators
- Per Aspenberg, MD, PhD, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767169
- Sponsor's protocol ID
- Tandskruv1
- Status last verified
- Dec 2013
- First submitted
- 3 Oct 2008
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Abtahi J, Tengvall P, Aspenberg P. A bisphosphonate-coating improves the fixation of metal implants in human bone. A randomized trial of dental implants. Bone. 2012 May;50(5):1148-51. doi: 10.1016/j.bone.2012.02.001. Epub 2012 Feb 10.
PubMed 22348981
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisphosphonate-coated Dental Implants
- ClinicalTrials.gov ID
- NCT00767169
- Acronym / sponsor ID
- Tandskruv1
- Conditions
- Edentatio (Toothlessness)
- Keywords
- Edentatio (Toothlessness)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Oct 2008 (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.
Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. The screws are compared by measuring how well fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the bisphosphonates will improve fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coated implant and control | Experimental | Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Need for at least 2 dental implants, which are to be inserted in bone of reasonably similar quality.
Key exclusion criteria (3 listed)
- Systemic or immunologic disease, alcoholism, uncontrolled diabetes and smoking.
- Local exclusion criteria were: previous tumour, trauma and surgery.
- Also patients with Cawood \& Howell class IV - VI maxilla-bone were excluded.
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 |
|---|---|---|
| Dental implant coating with a fibrinogen carrier for pamidronate and ibandronateDental implant coating with a fibrinogen carrier for pamidronate and ibandronate compared with uncoated controls in the same mouth. | Device | coated implant and control |
Primary outcome
Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.
Time frame: 6 months
1 secondary outcome
Marginal resorption on x-rays
Time frame: 1 year
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 Dec 2013.
- Results publication: PubMed 22348981Abtahi J, Tengvall P, Aspenberg P. A bisphosphonate-coating improves the fixation of metal implants in human bone. A randomized trial of dental implants. Bone. 2012 May;50(5):1148-51. doi: 10.1016/j.bone.2012.02.001. Epub 2012 Feb 10.
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.
Per Aspenberg, MD, PhD study chair
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate in people with Edentatio (Toothlessness), run by University Hospital, Linkoeping at 1 site 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 1 inclusion and 3 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 Dec 2013. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient. (time frame: 6 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 NCT00767169, 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 Dec 2013.