Bone LossNCT01961635
Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss
A study testing dental implants, Zirconia abutments and Titanium Abutments in people with Bone Loss and Inflammation, run by Implantology Institute at 1 site in Portugal.
Trial summary
In patients that require a dental implant, does zirconia compared to titanium, or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Inflammation
- What is being tested?
- dental implants, Zirconia abutments and Titanium Abutments
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2016to 23 Mar 2017
- Phase
- Interventional
- 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
- Single unit implant rehabilitation
- Maxilla and mandible
- Must accept treatment plan
- Must sign informed consent
- dental extraction performed at least 3 month prior
- Must have at least 6 mm of residual bone
- Absence of oral lesions
- keratinized tissue must be present
Who cannot join
- If smoking and/or other drug addiction is present
- If local anesthetic allergy is present
- Patient subjected to chemical or radiotherapy
- if Hepatic disease is present
- If immunodepression is present
- If Pregnancy is present
- If Diabetes is present
- If Heart disease is present
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial
In patients that require a dental implant, does zirconia compared to titanium, or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ?
Read the detailed description
Place dental Implants and zirconia, titanium, acrylic or cad-cam acrylic abutments, torque to 20 n/cm2 Evaluate Changes in inflammatory levels from T0 (baseline) to T7-12 weeks (measure intermediate points at T0 (baseline),,T1-8 Weeks and T2-12 weeks) Also evaluate outcomes marginal bone loss, gingival height levels and osseointegration
- Conditions
- Bone Loss, Inflammation
- Being tested
- dental implants, Zirconia abutments, Titanium Abutments, cad-cam acrylic abutments, Subcrestal
- Keywords
- Dental Implants, Zirconia Abutments, Titanium abutments, Acrylic abutments, Gingival Healing, Inflammation, Bone loss
- Medical subject headings
- Bone Diseases, Metabolic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantsDevice
Also called T3 - Biomet 3I Implants, Platform-Switch 4.1, Abutment Diameter 3.25
place implant according fabricant guidelines, 2mm sub-crestally
Zirconia abutmentsDevice
Also called Zirconia cad-cam abutment, 3.25 Abutment connection
place zirconia abutment on the day of implant placement
Titanium AbutmentsDevice
Also called Titanium Encode - biomet 3I Implants, 3,25 abutment connection
place titanium abutment on the day of implant placement
cad-cam acrylic abutmentsDevice
Also called Cad-cam acrylic abutment, 3.25 platform
place cad-cam acrylic abutment on the day of implant placement
SubcrestalProcedure or surgery
place implant 2mm below crestal bone
platform-switchDevice
abutment platform is narrow than implant diameter
one-time one-abutmentProcedure or surgery
Also called one time abutment, final abutment on the day of surgery
place the final abutment on the day of surgery and not remove it
Torque 20 n/cm2Procedure or surgery
Also called manual torque
the amount of torque applied to the abutment
| Study group | Role | What they receive |
|---|---|---|
| Zirconia Abutments | Experimental | Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Receives: Device: dental implants; Device: Zirconia abutments; Procedure: Subcrestal; Device: platform-switch; Procedure: one-time one-abutment; Procedure: Torque 20 n/cm2 |
| Titanium Abutments | Experimental | Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Receives: Device: dental implants; Device: Titanium Abutments; Procedure: Subcrestal; Device: platform-switch; Procedure: one-time one-abutment; Procedure: Torque 20 n/cm2 |
| Cad-Cam Acrylic abutments | Experimental | Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 Receives: Device: dental implants; Device: cad-cam acrylic abutments; Procedure: Subcrestal; Device: platform-switch; Procedure: one-time one-abutment; Procedure: Torque 20 n/cm2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Inflammatory Changes from baseline to 12 weeks
measure the amount of cytokines and interleukines (interleukin-8 (IL-8), macrophage inflammatory protein-1 (MIP-1 beta), interleukin-1 (IL-1 beta), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and matrix metalloproteinase-9 (MMP-9), metallopeptidase inhibitor 1 (TIMP-1), vascular endothelial growth factor (VEGF)), around different implant abutment materials, zirconia,titanium, acrylic, and cad-cam acrylic
Measured: Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks
Secondary outcomes (4)
Marginal Bone Loss
Parallel periapical standardized radiographs to measure bone position in relation to implant platform, in zirconia,titanium, acrylic, and cad-cam acrylic
Measured: measured at 12 weeks post-implant installation
Gingival height
measure with periodontal probe distance from implant platform to the most coronal point of gingival margin mesial, distal, buccal and lingual,in zirconia,titanium, acrylic, and cad-cam acrylic
Measured: 12 weeks post-implant installation
Osseointegration
compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments
Measured: 12 weeks post-implant installation
Height from gingiva to abutment
height from gingival margin to most coronal point of the abutment in zirconia, titanium, acrylic and acrylic cad-cam abutments
Measured: 12 weeks post implant installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startJan 2016
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Chen, Implantology Institute
- Investigators
- João Caramês, Phd, Principal investigator, Faculdade de Medicina Dentária de LisboaAndré Chen Chen, Msc, Study director, Faculdade de Medicina Dentária de LisboaElena Cervino, Msc, Study chair, Implantology InstituteHelena Francisco, Phd, Study chair, Faculdade de Medicina Dentária de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961635
- Sponsor's protocol ID
- II-01
- Status last verified
- Apr 2017
- First submitted
- 6 Oct 2013
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01961635
- Acronym / sponsor ID
- II-01
- Conditions
- Bone Loss, Inflammation
- Keywords
- Dental Implants, Zirconia Abutments, Titanium abutments, Acrylic abutments, Gingival Healing, Inflammation, Bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 11 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 require a dental implant, does zirconia compared to titanium, or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ?
Detailed description
Place dental Implants and zirconia, titanium, acrylic or cad-cam acrylic abutments, torque to 20 n/cm2 Evaluate Changes in inflammatory levels from T0 (baseline) to T7-12 weeks (measure intermediate points at T0 (baseline),,T1-8 Weeks and T2-12 weeks) Also evaluate outcomes marginal bone loss, gingival height levels and osseointegration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zirconia Abutments | Experimental | Device: dental implants, Device: Zirconia abutments, Procedure: Subcrestal, Device: platform-switch, Procedure: one-time one-abutment, Procedure: Torque 20 n/cm2Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 |
| Titanium Abutments | Experimental | Device: dental implants, Device: Titanium Abutments, Procedure: Subcrestal, Device: platform-switch, Procedure: one-time one-abutment, Procedure: Torque 20 n/cm2Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 |
| Cad-Cam Acrylic abutments | Experimental | Device: dental implants, Device: cad-cam acrylic abutments, Procedure: Subcrestal, Device: platform-switch, Procedure: one-time one-abutment, Procedure: Torque 20 n/cm2Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Single unit implant rehabilitation
- Maxilla and mandible
- Must accept treatment plan
- Must sign informed consent
- dental extraction performed at least 3 month prior
Key exclusion criteria (8 listed)
- If smoking and/or other drug addiction is present
- If local anesthetic allergy is present
- Patient subjected to chemical or radiotherapy
- if Hepatic disease is present
- If immunodepression is present
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 implantsAlso: T3 - Biomet 3I Implants, Platform-Switch 4.1, Abutment Diameter 3.25place implant according fabricant guidelines, 2mm sub-crestally | Device | Cad-Cam Acrylic abutments, Titanium Abutments, Zirconia Abutments |
| Zirconia abutmentsAlso: Zirconia cad-cam abutment, 3.25 Abutment connectionplace zirconia abutment on the day of implant placement | Device | Zirconia Abutments |
| Titanium AbutmentsAlso: Titanium Encode - biomet 3I Implants, 3,25 abutment connectionplace titanium abutment on the day of implant placement | Device | Titanium Abutments |
| cad-cam acrylic abutmentsAlso: Cad-cam acrylic abutment, 3.25 platformplace cad-cam acrylic abutment on the day of implant placement | Device | Cad-Cam Acrylic abutments |
| Subcrestalplace implant 2mm below crestal bone | Procedure or surgery | Cad-Cam Acrylic abutments, Titanium Abutments, Zirconia Abutments |
| platform-switchabutment platform is narrow than implant diameter | Device | Cad-Cam Acrylic abutments, Titanium Abutments, Zirconia Abutments |
| one-time one-abutmentAlso: one time abutment, final abutment on the day of surgeryplace the final abutment on the day of surgery and not remove it | Procedure or surgery | Cad-Cam Acrylic abutments, Titanium Abutments, Zirconia Abutments |
| Torque 20 n/cm2Also: manual torquethe amount of torque applied to the abutment | Procedure or surgery | Cad-Cam Acrylic abutments, Titanium Abutments, Zirconia Abutments |
Primary outcome
Gingival Inflammatory Changes from baseline to 12 weeks
Time frame: Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks
measure the amount of cytokines and interleukines (interleukin-8 (IL-8), macrophage inflammatory protein-1 (MIP-1 beta), interleukin-1 (IL-1 beta), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and matrix metalloproteinase-9 (MMP-9), metallopeptidase inhibitor 1 (TIMP-1), vascular endothelial growth factor (VEGF)), around different implant abutment materials, zirconia,titanium, acrylic, and cad-cam acrylic
4 secondary outcomes
Marginal Bone Loss
Time frame: measured at 12 weeks post-implant installation
Gingival height
Time frame: 12 weeks post-implant installation
Osseointegration
Time frame: 12 weeks post-implant installation
Height from gingiva to abutment
Time frame: 12 weeks post implant installation
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 2 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
João Caramês, Phd principal investigator
Faculdade de Medicina Dentária de Lisboa
André Chen Chen, Msc study director
Faculdade de Medicina Dentária de Lisboa
Elena Cervino, 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?
A study testing dental implants, Zirconia abutments and Titanium Abutments in people with Bone Loss and Inflammation, 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 8 inclusion and 8 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 2 May 2017. 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?
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?
Gingival Inflammatory Changes from baseline to 12 weeks (time frame: Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 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 2 May 2017.