Dental Implant, Single-ToothNCT01871220
Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles
A study testing Concave Transition Profile and Divergent Transition Profile in people with Dental Implant, Single-Tooth and Esthetics, Dental, run by Christopher Barwacz at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Single-Tooth, Esthetics, Dental
- What is being tested?
- Concave Transition Profile and Divergent Transition Profile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2013to 3 Oct 2018
- Phase
- Interventional
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or greater
- Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration
- Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (<2.0mm) and/or significant soft tissue loss
- An opposing dentition with teeth, implants, or fixed prosthesis
- Subjects must be willing to follow instructions related to the study procedures
- Subjects must have read, understood, and signed the informed consent document
Who cannot join
- Insufficient interocclusal space for implant placement and/or restoration at study site
- More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth
- Untreated rampant caries
- Tobacco use free for ≤ 6 months
- Liver or kidney disfunction/failure
- Active severe infectious diseases that may affect normal healing and/or bone metabolism (e.g. AIDS)
Show all 15Show fewer
- Uncontrolled diabetes
- Current alcohol or drug abuse
- Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
- History of relevant head/neck cancer and/or radiation of the head/neck
- Subjects who currently use bisphosphonates or have a history of bisphosphonate use
- Subjects with metabolic bone diseases such as osteoporosis or Paget's disease of bone
- Known pregnancy or nursing mothers
- Unable or unwilling to return for follow-up visits for a period of 1 year
- Unlikely to be able to comply with study procedures according to investigators judgement
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa College of Dentistry
Iowa City, Iowa, 52242
About this study
Official title: Peri-implant Mucosa Dynamics Around Divergent and Concave Atlantis™ Abutment Transition Profiles.
The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement.
Read the detailed description
This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments.
Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited.
The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year.
- Conditions
- Dental Implant, Single-Tooth, Esthetics, Dental
- Being tested
- Concave Transition Profile, Divergent Transition Profile
- Keywords
- Implant Abutments, Oral Mucosa Changes, Implant Esthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concave Transition ProfileDevice
An Atlantis abutment is delivered with a concave transition profile.
Divergent Transition ProfileDevice
An Atlantis abutment is delivered with a linear transition profile
| Study group | Role | What they receive |
|---|---|---|
| Divergent Abutment | Active comparator | Divergent Transition Profile Receives: Device: Divergent Transition Profile |
| Concave Abutment | Experimental | Concave Transition Profile Receives: Device: Concave Transition Profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
Determine if there is a difference in soft tissue peri-implant zenith changes (in millimeters) for the concave/divergent abutment sites, specifically between at delivery and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Measured: Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Secondary outcomes (2)
Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery
Determine if there is a difference in submarginal buccal-lingual soft tissue thickness in the peri-implant transition zone relative to a fixed reference point, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Measured: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
Determine if there is a difference in Keratinized Mucosa Width (millimeters) in the apico-coronal direction at the midfacial aspect of the implant site, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Measured: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study start30 Dec 2013
- Primary completion3 Oct 2018
- Study completion3 Oct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Implant, Single-ToothStudies 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
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Barwacz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Barwacz, University of Iowa
- Investigators
- Christopher A Barwacz, DDS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871220
- Sponsor's protocol ID
- 201302798
- Status last verified
- May 2022
- First submitted
- 3 Jun 2013
- Last updated
- 14 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barwacz CA, Swenson M, Couso-Queiruga E, Comnick C, Xie XJ, Avila-Ortiz G. Effect of CAD/CAM Abutment Morphology on the Outcomes of Implant Therapy: A Randomized Controlled Trial. Clin Oral Implants Res. 2025 Mar;36(3):374-385. doi: 10.1111/clr.14389. Epub 2024 Dec 6.
PubMed 39641983
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Mucosa Dynamics Around Divergent and Concave Atlantis™ Abutment Transition Profiles.
- ClinicalTrials.gov ID
- NCT01871220
- Acronym / sponsor ID
- 201302798
- Conditions
- Dental Implant, Single-Tooth, Esthetics, Dental
- Keywords
- Implant Abutments, Oral Mucosa Changes, Implant Esthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Christopher BarwaczUniversity, hospital or other
- Study start
- 30 Dec 2013 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 14 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement.
Detailed description
This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments.
Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited.
The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divergent Abutment | Active comparator | Device: Divergent Transition ProfileDivergent Transition Profile |
| Concave Abutment | Experimental | Device: Concave Transition ProfileConcave Transition Profile |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or greater
- Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration
- Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (<2.0mm) and/or significant soft tissue loss
- An opposing dentition with teeth, implants, or fixed prosthesis
- Subjects must be willing to follow instructions related to the study procedures
Key exclusion criteria (15 listed)
- Insufficient interocclusal space for implant placement and/or restoration at study site
- More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth
- Untreated rampant caries
- Tobacco use free for ≤ 6 months
- Liver or kidney disfunction/failure
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 |
|---|---|---|
| Concave Transition ProfileAn Atlantis abutment is delivered with a concave transition profile. | Device | Concave Abutment |
| Divergent Transition ProfileAn Atlantis abutment is delivered with a linear transition profile | Device | Divergent Abutment |
Primary outcome
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
Time frame: Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Determine if there is a difference in soft tissue peri-implant zenith changes (in millimeters) for the concave/divergent abutment sites, specifically between at delivery and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
2 secondary outcomes
Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery
Time frame: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
Time frame: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39641983Barwacz CA, Swenson M, Couso-Queiruga E, Comnick C, Xie XJ, Avila-Ortiz G. Effect of CAD/CAM Abutment Morphology on the Outcomes of Implant Therapy: A Randomized Controlled Trial. Clin Oral Implants Res. 2025 Mar;36(3):374-385. doi: 10.1111/clr.14389. Epub 2024 Dec 6.
- Individual participant dataSharing planned: No
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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.
Christopher A Barwacz, DDS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concave Transition Profile and Divergent Transition Profile in people with Dental Implant, Single-Tooth and Esthetics, Dental, run by Christopher Barwacz at 1 site 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 15 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 14 Jun 2022. 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 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 14 Jun 2022). 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?
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites (time frame: Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery). 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 NCT01871220, 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 14 Jun 2022.