Pre-integration Failure of Dental ImplantPhase 2NCT02044978
Initial Fixation of Bisphosphonate-coated Dental Implants
A Phase 2 study testing Zoledronate-coated dental implant in people with Pre-integration Failure of Dental Implant, run by Per Aspenberg at 2 sites in Sweden.
Trial summary
16 patients will be included. Each patient receives 2 dental implants. One of them is coated with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in each patient are compared. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pre-integration Failure of Dental Implant
- What is being tested?
- Zoledronate-coated dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2014to Jan 2017
- 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 dental implant in upper jaw. CTscan showing at least 6 mm bucco-lingual thickness. Generally healthy
Who cannot join
- Drugs or conditions that influence or are thought to influence bone healing, such as bisphosphonates, corticosteroids, other oral pathologies, severe autoimmune diseases, cancer. Osteoporosis is not cause for exclusion.
Trial locations and contacts
2 sites in 1 country.
Jahan Abtahi, MD, PhD contact
Per Aspenberg, MD, PhD contact
Sweden2 sites, 2 recruiting
- Recruiting
Käkcentralen
Linköping, 58185
Jahan Abtahi, MD PhD, jahan.abtahi@lio.se
Jahan Abtahi, MD PhD
- Recruiting
Tandläkarhuset
Linköping, 58227
Jahan Abtahi, MD PhD, jahan.abtahi@lio.se
About this study
16 patients will be included. Each patient receives 2 dental implants. One of them is coated with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in each patient are compared. We expect to find an early improvement (higher resonance frequency) in the coated implant.
Read the detailed description
The zoledronate is linked to the titanium implant surface via a nanolayer of crosslinked fibrinigen. Resonance frequency is measured with standard clinical equipment (Ostell apparatus).
- Being tested
- Zoledronate-coated dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronate-coated dental implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Bisphosphonate implant | Active comparator | Dental implant coated with zoledronate Note: Both arms in each patient (2 implants) Receives: Device: Zoledronate-coated dental implant |
| control | Placebo comparator | Dental implant without coating Note: Both arms in each patient (2 implants) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibration frequency ratio
Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for 4 and 6 weeks will be used.
Measured: 4 and 6 weeks
Secondary outcomes (2)
Marginal resorption
Radiographic loss of bone at the margin of the implant, measured as difference in mm from the superficial bone contour between insertion and 8 weeks.
Measured: 8 weeks
Vibration: area under the curve
Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for all weeks will be used.
Measured: 2-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-integration Failure of Dental ImplantStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Per Aspenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Aspenberg, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044978
- Sponsor's protocol ID
- Tandskruv tidsserie
- Status last verified
- Jun 2015
- First submitted
- 22 Jan 2014
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Fixation of Bisphosphonate-coated Dental Implants
- ClinicalTrials.gov ID
- NCT02044978
- Acronym / sponsor ID
- Tandskruv tidsserie
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Per AspenbergUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 24 Jan 2014 (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.
16 patients will be included. Each patient receives 2 dental implants. One of them is coated with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in each patient are compared. We expect to find an early improvement (higher resonance frequency) in the coated implant.
Detailed description
The zoledronate is linked to the titanium implant surface via a nanolayer of crosslinked fibrinigen. Resonance frequency is measured with standard clinical equipment (Ostell apparatus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bisphosphonate implant | Active comparator | Device: Zoledronate-coated dental implantDental implant coated with zoledronate Note: Both arms in each patient (2 implants) |
| control | Placebo comparator | –Dental implant without coating Note: Both arms in each patient (2 implants) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Need for dental implant in upper jaw. CTscan showing at least 6 mm bucco-lingual thickness. Generally healthy
Key exclusion criteria (1 listed)
- Drugs or conditions that influence or are thought to influence bone healing, such as bisphosphonates, corticosteroids, other oral pathologies, severe autoimmune diseases, cancer. Osteoporosis is not cause for exclusion.
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 |
|---|---|---|
| Zoledronate-coated dental implant | Device | Bisphosphonate implant |
Primary outcome
Vibration frequency ratio
Time frame: 4 and 6 weeks
Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for 4 and 6 weeks will be used.
2 secondary outcomes
Marginal resorption
Time frame: 8 weeks
Vibration: area under the curve
Time frame: 2-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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.
Jahan Abtahi, MD, PhD contact
Per Aspenberg, MD, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronate-coated dental implant in people with Pre-integration Failure of Dental Implant, run by Per Aspenberg at 2 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jahan Abtahi, MD, PhD (jahan.abtahi@lio.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibration frequency ratio (time frame: 4 and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2015.