Dental ImplantsNCT02496091
Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants
An observational study of Dental Implants, run by Dentsply Sirona Implants and Consumables at 6 sites in United States.
Trial summary
The study is designed as a retrospective and multi-center study. The study population is US individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- ATLANTIS Abutment
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Aug 2015to 30 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population is individuals who received ATLANTIS abutments, between 2010 and 2013, connected to implants from BIOMET 3i, Straumann, Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System) replacing one or more teeth, in any position in the mouth, as part of a permanent prosthetic restoration. The partially dentate individuals have received either single-unit crowns or fixed partial or full dentures. The abutments need to be titanium or gold-shaded titanium.
Who may be able to join
- Having received one or more ATLANTIS abutments included in one or more permanent prosthetic restoration(s):
- during 2010, 2011, 2012 or 2013
- made of titanium or gold-shaded titanium
- connected to implants from: BIOMET 3i; Straumann; Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System).
- Being at least 18 years at day of enrollment
- Having signed and dated the informed consent form
Who cannot join
- Unable to come for study visit
- Not willing to participate in the study or not able to understand the content of the study.
- Involvement in the planning and conduct of the study (applies to both DENTSPLY Implants staff and staff at the study site).
- Simultaneous participation in another clinical study that may interfere with the present study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham, Division of Prosthodontics
Birmingham, Alabama, 35294-0007
University of North Carolina, School of Dentistry
Chapel Hill, North Carolina, 27599
Nova Southeastern University, College of Dental Medicine
Fort Lauderdale, Florida, 33328
University of Iowa, College of Dentistry
Iowa City, Iowa, 52242
University of California, Los Angeles, School of Dentistry
Los Angeles, California, 90095
Columbia University, College of Dental Medicine
New York, New York, 10032
About this study
Official title: A Retrospective Multicenter Study Evaluating ATLANTIS™ Abutments on Implants From Four Manufacturers
The study is designed as a retrospective and multi-center study. The study population is US individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments. The study includes retrospective data collection from the medical records and data collection from one prospective study visit with a clinical examination.The primary objective is to evaluate success. Success is defined as that the study implant and abutment are in situ and no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant tissues are reported during the study.
- Conditions
- Dental Implants
- Being tested
- ATLANTIS Abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLANTIS AbutmentDevice
| Study group | Role | What they receive |
|---|---|---|
| ATLANTIS Abutment | The investigational product (ATLANTIS abutment) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products. Receives: Device: ATLANTIS Abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success Rate
Success defined as study position implant and abutment in situ and no Adverse Event(s) related to implant, abutment or adjacent peri-implant tissues reported during study.
Measured: Minium of 2 years and a maximum of 8 years of use.
Secondary outcomes (5)
Study Position Implant and Abutment Survival
Survival defined as study position implant and abutment in situ during study. The presence of the study position implant and abutment in the mouth was recorded. The implant and abutment had to be the ones included in the permanent prosthetic restoration when it was delivered / installed.
Each study position was categorized as survived (No/Yes). It was categorized as survived=Yes when both had been in situ during study. It was categorized as survived=No when either the implant or abutment had been lost during study.
Measured: Minium of 2 years and a maximum of 8 years of use.
Presence of Plaque
Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.
Measured: Minium of 2 years and a maximum of 8 years of use.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
PPD was evaluated at four surfaces around each study position (mesial, facial, distal and lingual), using a periodontal probe. PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in whole millimetre. PPD mean values per study positon were calculated.
Measured: Minium of 2 years and a maximum of 8 years of use.
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). BoP was evaluated at four surfaces around each study position (mesial, facial, distal and lingual), using a periodontal probe.
BoP was recorded as presence or absence of bleeding when probing to the bottom of the pocket. Presented as % of positions that show presence of bleeding on probing at time of the follow-up visit.
Measured: Minium of 2 years and a maximum of 8 years of use.
Marginal Bone Level Change
Marginal bone level (MBL) determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the study follow-up visit was compared to values obtained at delivery of permanent restoration i.e. loading (baseline), or within the first 12 months after loading.
Measured: Minium of 2 years and a maximum of 8 years of use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start31 Aug 2015
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Ingeborg J. Dr De Kok, DDS, Principal investigator, University of North Carolina, School of Dentistry, Chapel Hill, NC 27599, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496091
- Sponsor's protocol ID
- C-AA-14-003
- Status last verified
- Apr 2020
- First submitted
- 20 May 2015
- Last updated
- 28 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Study Evaluating ATLANTIS™ Abutments on Implants From Four Manufacturers
- ClinicalTrials.gov ID
- NCT02496091
- Acronym / sponsor ID
- C-AA-14-003
- Conditions
- Dental Implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Posted 28 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed as a retrospective and multi-center study. The study population is US individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments. The study includes retrospective data collection from the medical records and data collection from one prospective study visit with a clinical examination.The primary objective is to evaluate success. Success is defined as that the study implant and abutment are in situ and no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant tissues are reported during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATLANTIS Abutment | – | Device: ATLANTIS AbutmentThe investigational product (ATLANTIS abutment) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is individuals who received ATLANTIS abutments, between 2010 and 2013, connected to implants from BIOMET 3i, Straumann, Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System) replacing one or more teeth, in any position in the mouth, as part of a permanent prosthetic restoration. The partially dentate individuals have received either single-unit crowns or fixed partial or full dentures. The abutments need to be titanium or gold-shaded titanium.
Key inclusion criteria (6 listed)
- Having received one or more ATLANTIS abutments included in one or more permanent prosthetic restoration(s):
- Being at least 18 years at day of enrollment
- Having signed and dated the informed consent form
Key exclusion criteria (4 listed)
- Unable to come for study visit
- Not willing to participate in the study or not able to understand the content of the study.
- Involvement in the planning and conduct of the study (applies to both DENTSPLY Implants staff and staff at the study site).
- Simultaneous participation in another clinical study that may interfere with the present study
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 |
|---|---|---|
| ATLANTIS Abutment | Device | ATLANTIS Abutment |
Primary outcome
Overall Success Rate
Time frame: Minium of 2 years and a maximum of 8 years of use.
Success defined as study position implant and abutment in situ and no Adverse Event(s) related to implant, abutment or adjacent peri-implant tissues reported during study.
5 secondary outcomes
Study Position Implant and Abutment Survival
Time frame: Minium of 2 years and a maximum of 8 years of use.
Presence of Plaque
Time frame: Minium of 2 years and a maximum of 8 years of use.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Time frame: Minium of 2 years and a maximum of 8 years of use.
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP
Time frame: Minium of 2 years and a maximum of 8 years of use.
Marginal Bone Level Change
Time frame: Minium of 2 years and a maximum of 8 years of use.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dr Ingeborg J. Dr De Kok, DDS principal investigator
University of North Carolina, School of Dentistry, Chapel Hill, NC 27599, US
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Dentsply Sirona Implants and Consumables at 6 sites in United States.
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 6 inclusion and 4 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Success Rate (time frame: Minium of 2 years and a maximum of 8 years of use.). 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 28 Apr 2020.