ImplantsNCT01971268
Compare the Success Rate of T3 Dental Implant (Biomet 3I) With or Without Platform-switch Concept
An observational study of Implants and Bone Loss, run by Implantology Institute at 1 site in Portugal.
Trial summary
In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch concept compared to the use of platform-matched concept, refrain marginal bone loss during osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement of the final restoration = at 18 weeks=T2) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Dental Implant, Platform-Switch Dental Implant and Platform-Matched dental implant
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2014to Jan 2015
- Phase
- Observational
- 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
Study population: Population from a private office who seek care to replace missing teeth, must have economical status to do implant supported rehabilitations
Who may be able to join
- Single unit implant rehabilitation
- Maxilla and mandible
- Biomet 3I T3 dental implant placed
- Final Rehabilitation placed
Who cannot join
- Immediate implants
- Radiographic impossibility of measure
- Absence of baseline T0 radiograph
- Smoking habits (more 10 cigarets a day)
- Diabetes
- Patients who receive Radio or/and Chemotherapy
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto de Implantologia
Lisbon, Lisbon District, 1500-662
Joana Velez, joana.velez@institutodeimplantologia.com
Andre Chen, Msc
About this study
Official title: Marginal Bone Behavior of Dental Implants to Different Rehabilitation Protocols
In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch concept compared to the use of platform-matched concept, refrain marginal bone loss during osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement of the final restoration = at 18 weeks=T2)
Read the detailed description
Patients from a private practice who received dental implants (T3 dental implant Biomet 3I) from November 2012 to October 2013 were eligible to enter the study.
Two groups were formed: one group received a T3 dental implant with platform switch concept and the other received an implant with platform matched type of connection.
We evaluate osseointegration at T1 (12 weeks) and marginal bone position in relation to the implant platform at baseline (implant installation) T0 and again at T1 and T2.
From data recorder in T0,T1 and T2, we evaluate changes in marginal bone position.
- Being tested
- Dental Implant, Platform-Switch Dental Implant, Platform-Matched dental implant
- Keywords
- T3 dental implants, Marginal bone loss, Survival rate
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ImplantDevice
Also called Biomet 3i T3 dental implant
place dental implants according to manufacturer guidelines
Platform-Switch Dental ImplantDevice
Also called Biomet 3I Dental Implant Platform-Switch, Discrepant Platform implant, non-matched dental implant
Place Dental Implant with an abutment narrower than the implant platform
Platform-Matched dental implantDevice
Also called Biomet 3I T3 Dental Implant, non-discrepant platform dental implant
Place Dental Implant with abutment with same size as the platform
| Study group | Role | What they receive |
|---|---|---|
| Platform-Switch Group | T3 dental implant, with platform-switch dental implant platform concept, measure marginal bone loss Receives: Device: Dental Implant; Device: Platform-Switch Dental Implant | |
| Platform-Matched Group | T3 dental implant, platform-matched dental implant platform concept, measure marginal bone loss Receives: Device: Dental Implant; Device: Platform-Matched dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position of Implant Platform to marginal bone
Compare marginal bone position at baseline T0 (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform.
Measured: At Baseline (T0)
Marginal Bone Position at 8 Weeks
Compare marginal bone position at T1, 12 weeks after baseline (T0) (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform
Measured: At 12 weeks (T1) after Baseline
Marginal Bone Position at 12 Weeks
Compare marginal bone position at T2, 18 weeks from baseline (T0) (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform.
Measured: At 18 Weeks (T2) after baseline (T0)
Secondary outcomes (1)
Osseointegration
measure the ability of the implant to integrate in bone
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Chen, Implantology Institute
- Investigators
- Andre Chen, Msc, Principal investigator, Implantology InstituteJoão Caramês, Phd, Study director, Implantology InstituteHelena Francisco, Msc, Study chair, Implantology InstituteElena Cervino, Msc, Study chair, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971268
- Sponsor's protocol ID
- II-02
- Status last verified
- Oct 2013
- First submitted
- 17 Oct 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Bone Behavior of Dental Implants to Different Rehabilitation Protocols
- ClinicalTrials.gov ID
- NCT01971268
- Acronym / sponsor ID
- II-02
- Keywords
- T3 dental implants, Marginal bone loss, Survival rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 29 Oct 2013 (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.
In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch concept compared to the use of platform-matched concept, refrain marginal bone loss during osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement of the final restoration = at 18 weeks=T2)
Detailed description
Patients from a private practice who received dental implants (T3 dental implant Biomet 3I) from November 2012 to October 2013 were eligible to enter the study.
Two groups were formed: one group received a T3 dental implant with platform switch concept and the other received an implant with platform matched type of connection.
We evaluate osseointegration at T1 (12 weeks) and marginal bone position in relation to the implant platform at baseline (implant installation) T0 and again at T1 and T2.
From data recorder in T0,T1 and T2, we evaluate changes in marginal bone position.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platform-Switch Group | – | Device: Dental Implant, Device: Platform-Switch Dental ImplantT3 dental implant, with platform-switch dental implant platform concept, measure marginal bone loss |
| Platform-Matched Group | – | Device: Dental Implant, Device: Platform-Matched dental implantT3 dental implant, platform-matched dental implant platform concept, measure marginal bone loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population from a private office who seek care to replace missing teeth, must have economical status to do implant supported rehabilitations
Key inclusion criteria (4 listed)
- Single unit implant rehabilitation
- Maxilla and mandible
- Biomet 3I T3 dental implant placed
- Final Rehabilitation placed
Key exclusion criteria (6 listed)
- Immediate implants
- Radiographic impossibility of measure
- Absence of baseline T0 radiograph
- Smoking habits (more 10 cigarets a day)
- Diabetes
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 ImplantAlso: Biomet 3i T3 dental implantplace dental implants according to manufacturer guidelines | Device | Platform-Matched Group, Platform-Switch Group |
| Platform-Switch Dental ImplantAlso: Biomet 3I Dental Implant Platform-Switch, Discrepant Platform implant, non-matched dental implantPlace Dental Implant with an abutment narrower than the implant platform | Device | Platform-Switch Group |
| Platform-Matched dental implantAlso: Biomet 3I T3 Dental Implant, non-discrepant platform dental implantPlace Dental Implant with abutment with same size as the platform | Device | Platform-Matched Group |
Primary outcome
Position of Implant Platform to marginal bone
Time frame: At Baseline (T0)
Compare marginal bone position at baseline T0 (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform.
Marginal Bone Position at 8 Weeks
Time frame: At 12 weeks (T1) after Baseline
Compare marginal bone position at T1, 12 weeks after baseline (T0) (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform
Marginal Bone Position at 12 Weeks
Time frame: At 18 Weeks (T2) after baseline (T0)
Compare marginal bone position at T2, 18 weeks from baseline (T0) (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform.
1 secondary outcome
Osseointegration
Time frame: At 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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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.
Andre Chen, Msc principal investigator
Implantology Institute
João Caramês, Phd study director
Implantology Institute
Helena Francisco, Msc study chair
Implantology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implants and Bone Loss, run by Implantology Institute at 1 site in Portugal.
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 6 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 29 Oct 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André Chen, Msc (00351919774343, tsouchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Position of Implant Platform to marginal bone (time frame: At Baseline (T0)). The study lists 3 primary outcomes in all. 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 29 Oct 2013.