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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Divergent Abutment | Active Comparator | Divergent Transition Profile |
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| Concave Abutment | Experimental | Concave Transition Profile |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concave Transition Profile | Device | An Atlantis abutment is delivered with a concave transition profile. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher A Barwacz, DDS | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Dentistry | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39641983 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Divergent Abutment | Divergent Transition Profile Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile |
| FG001 | Concave Abutment | Concave Transition Profile Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population differs from the final results (i.e., 12 months after baseline), because 7 subjects were lost to follow-up over the course of the study, specifically 4 from the Divergent Allocation and 3 from the Concave Allocation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Concave | Participants were missing a single-rooted tooth on the upper jaw and were randomly-assigned to receive a concave-shaped implant abutment. |
| BG001 | Divergent | Participants were missing a single-rooted tooth on the upper jaw and were randomly assigned to receive a divergent-shaped implant abutment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | millimeters | Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Divergent Abutment | Divergent Transition Profile Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Barwacz | University of Iowa College of Dentistry | 3193843002 | chris-barwacz@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2019 | Dec 2, 2021 | Prot_SAP_000.pdf |
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| Divergent Transition Profile | Device | An Atlantis abutment is delivered with a linear transition profile |
|
| 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. | Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Concave Abutment |
Concave Transition Profile Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile. |
|
|
| Secondary | 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. | The reason why the overall number of participants analyzed differs from the data in the rows is due to some participants being lost to follow-up. | Posted | Mean | Standard Deviation | millimeters | Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery |
|
|
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| Secondary | 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. | The reason why the number analyzed in one or more rows differs from the overall number analyzed is that some subjects were lost to follow-up. | Posted | Mean | Standard Deviation | millimeters | Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery |
|
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Concave Abutment | Concave Transition Profile Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile. | 0 | 32 | 0 | 32 | 0 | 32 |
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| 1 month after delivery |
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| 3 months after delivery |
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| 6 months after delivery |
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| 12 months after delivery |
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| 1 month after delivery |
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| 3 months after delivery |
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| 6 months after delivery |
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| 12 months after delivery |
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