Dental Implant, Single-Tooth, Esthetics, Dental
Conditions
Keywords
Implant Abutments, Oral Mucosa Changes, Implant Esthetics
Brief 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.
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.
Interventions
DEVICEConcave Transition Profile
An Atlantis abutment is delivered with a concave transition profile.
DEVICEDivergent Transition Profile
An Atlantis abutment is delivered with a linear transition profile
Sponsors
Christopher Barwacz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration 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. |
| Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Concave Participants were missing a single-rooted tooth on the upper jaw and were randomly-assigned to receive a concave-shaped implant abutment. | 32 |
| Divergent Participants were missing a single-rooted tooth on the upper jaw and were randomly assigned to receive a divergent-shaped implant abutment. | 29 |
| Total | 61 |
Baseline characteristics
| Characteristic | Concave | Divergent | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 3 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 26 Participants | 52 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 10 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 19 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 32 |
| other Total, other adverse events | 0 / 29 | 0 / 32 |
| serious Total, serious adverse events | 0 / 29 | 0 / 32 |
Outcome results
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.
Time frame: Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Divergent Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 1 Month After Delivery | 9.684 millimeters | Standard Deviation 1.203 |
| Divergent Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 6 Months after Delivery | 9.652 millimeters | Standard Deviation 1.166 |
| Divergent Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 3 Months after Delivery | 9.674 millimeters | Standard Deviation 1.231 |
| Divergent Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 12 Months after Delivery | 9.622 millimeters | Standard Deviation 1.258 |
| Divergent Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | Delivery | 9.860 millimeters | Standard Deviation 1.148 |
| Concave Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 12 Months after Delivery | 9.596 millimeters | Standard Deviation 1.167 |
| Concave Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | Delivery | 9.770 millimeters | Standard Deviation 1.146 |
| Concave Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 1 Month After Delivery | 9.618 millimeters | Standard Deviation 1.16 |
| Concave Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 3 Months after Delivery | 9.610 millimeters | Standard Deviation 1.174 |
| Concave Abutment | Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites | 6 Months after Delivery | 9.599 millimeters | Standard Deviation 1.16 |
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.
Time frame: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Divergent Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | 1 month after delivery | 3.407 millimeters | Standard Deviation 1.1522 |
| Divergent Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | 6 months after delivery | 3.478 millimeters | Standard Deviation 0.9946 |
| Divergent Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | 3 months after delivery | 3.620 millimeters | Standard Deviation 0.893 |
| Divergent Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | 12 months after delivery | 3.560 millimeters | Standard Deviation 1.0832 |
| Divergent Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | Baseline | 2.704 millimeters | Standard Deviation 1.1373 |
| Concave Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | 12 months after delivery | 4.035 millimeters | Standard Deviation 1.8609 |
| Concave Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | Baseline | 3.307 millimeters | Standard Deviation 1.8425 |
| Concave Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | 1 month after delivery | 3.936 millimeters | Standard Deviation 1.7212 |
| Concave Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | 3 months after delivery | 4.177 millimeters | Standard Deviation 1.6711 |
| Concave Abutment | Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. | 6 months after delivery | 4.067 millimeters | Standard Deviation 1.6439 |
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.
Time frame: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Divergent Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | 6 months after delivery | 2.920 millimeters | Standard Deviation 0.6403 |
| Divergent Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | Baseline | 2.722 millimeters | Standard Deviation 1.1294 |
| Divergent Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | 1 month after delivery | 2.667 millimeters | Standard Deviation 0.6202 |
| Divergent Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | 3 months after delivery | 2.840 millimeters | Standard Deviation 0.7176 |
| Divergent Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | 12 months after delivery | 2.740 millimeters | Standard Deviation 0.7654 |
| Concave Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | 12 months after delivery | 2.500 millimeters | Standard Deviation 0.5 |
| Concave Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | 3 months after delivery | 2.468 millimeters | Standard Deviation 0.5764 |
| Concave Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | Baseline | 2.814 millimeters | Standard Deviation 1.1291 |
| Concave Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | 6 months after delivery | 2.517 millimeters | Standard Deviation 0.5796 |
| Concave Abutment | Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery | 1 month after delivery | 2.597 millimeters | Standard Deviation 0.6248 |