Trial Outcomes & Findings for Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles (NCT NCT01871220)
NCT ID: NCT01871220
Last Updated: 2022-06-14
Results Overview
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.
COMPLETED
NA
61 participants
Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
2022-06-14
Participant Flow
Participant milestones
| Measure |
Divergent Abutment
Divergent Transition Profile
Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile
|
Concave Abutment
Concave Transition Profile
Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
|
Overall Study
COMPLETED
|
25
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Concave
n=32 Participants
Participants were missing a single-rooted tooth on the upper jaw and were randomly-assigned to receive a concave-shaped implant abutment.
|
Divergent
n=29 Participants
Participants were missing a single-rooted tooth on the upper jaw and were randomly assigned to receive a divergent-shaped implant abutment.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=32 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=32 Participants
|
26 Participants
n=29 Participants
|
52 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=32 Participants
|
3 Participants
n=29 Participants
|
9 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=32 Participants
|
10 Participants
n=29 Participants
|
29 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=32 Participants
|
19 Participants
n=29 Participants
|
32 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration DeliveryDetermine 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.
Outcome measures
| Measure |
Divergent Abutment
n=25 Participants
Divergent Transition Profile
Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile
|
Concave Abutment
n=29 Participants
Concave Transition Profile
Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
|
|---|---|---|
|
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
Delivery
|
9.860 millimeters
Standard Deviation 1.148
|
9.770 millimeters
Standard Deviation 1.146
|
|
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
1 Month After Delivery
|
9.684 millimeters
Standard Deviation 1.203
|
9.618 millimeters
Standard Deviation 1.160
|
|
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
3 Months after Delivery
|
9.674 millimeters
Standard Deviation 1.231
|
9.610 millimeters
Standard Deviation 1.174
|
|
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
6 Months after Delivery
|
9.652 millimeters
Standard Deviation 1.166
|
9.599 millimeters
Standard Deviation 1.160
|
|
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
12 Months after Delivery
|
9.622 millimeters
Standard Deviation 1.258
|
9.596 millimeters
Standard Deviation 1.167
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration DeliveryPopulation: 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.
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.
Outcome measures
| Measure |
Divergent Abutment
n=27 Participants
Divergent Transition Profile
Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile
|
Concave Abutment
n=31 Participants
Concave Transition Profile
Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
|
|---|---|---|
|
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
|
2.814 millimeters
Standard Deviation 1.1291
|
|
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
|
2.597 millimeters
Standard Deviation 0.6248
|
|
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
|
2.468 millimeters
Standard Deviation 0.5764
|
|
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
|
2.517 millimeters
Standard Deviation 0.5796
|
|
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
|
2.500 millimeters
Standard Deviation 0.5000
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration DeliveryPopulation: 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.
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.
Outcome measures
| Measure |
Divergent Abutment
n=27 Participants
Divergent Transition Profile
Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile
|
Concave Abutment
n=31 Participants
Concave Transition Profile
Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
|
|---|---|---|
|
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
Baseline
|
2.704 millimeters
Standard Deviation 1.1373
|
3.307 millimeters
Standard Deviation 1.8425
|
|
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
1 month after delivery
|
3.407 millimeters
Standard Deviation 1.1522
|
3.936 millimeters
Standard Deviation 1.7212
|
|
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
3 months after delivery
|
3.620 millimeters
Standard Deviation 0.8930
|
4.177 millimeters
Standard Deviation 1.6711
|
|
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
6 months after delivery
|
3.478 millimeters
Standard Deviation 0.9946
|
4.067 millimeters
Standard Deviation 1.6439
|
|
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
12 months after delivery
|
3.560 millimeters
Standard Deviation 1.0832
|
4.035 millimeters
Standard Deviation 1.8609
|
Adverse Events
Divergent Abutment
Concave Abutment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christopher Barwacz
University of Iowa College of Dentistry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place