Trial Outcomes & Findings for Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants (NCT NCT02496091)
NCT ID: NCT02496091
Last Updated: 2020-04-28
Results Overview
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.
COMPLETED
144 participants
Minium of 2 years and a maximum of 8 years of use.
2020-04-28
Participant Flow
Unit of analysis: Abutments
Participant milestones
| Measure |
ATLANTIS Abutment
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Overall Study
STARTED
|
144 263
|
|
Overall Study
COMPLETED
|
142 259
|
|
Overall Study
NOT COMPLETED
|
2 4
|
Reasons for withdrawal
| Measure |
ATLANTIS Abutment
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Overall Study
Eligibility criteria not fulfilled
|
2
|
Baseline Characteristics
Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants
Baseline characteristics by cohort
| Measure |
ATLANTIS Abutment
n=259 Abutments
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 11.85 • n=142 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=142 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=142 Participants
|
|
Region of Enrollment
United States
|
142 Participants
n=142 Participants
|
PRIMARY outcome
Timeframe: Minium of 2 years and a maximum of 8 years of use.Population: 144 subjects (263 implant positions) were signed informed consent and were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled. As a result, a total of 142 subjects (259 implant positions) are included in the analysis.
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.
Outcome measures
| Measure |
ATLANTIS Abutment
n=259 Abutments
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Overall Success Rate
|
240 Abutments
|
SECONDARY outcome
Timeframe: Minium of 2 years and a maximum of 8 years of use.Population: 144 subjects (263 implant positions) were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled giving a per protocol population of 142 subjects (259 positions).
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.
Outcome measures
| Measure |
ATLANTIS Abutment
n=259 Abutments
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Study Position Implant and Abutment Survival
|
256 Abutments
|
SECONDARY outcome
Timeframe: Minium of 2 years and a maximum of 8 years of use.Population: 144 subjects (263 implant positions) were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled giving a per protocol population of 142 subjects (259 positions) . Plaque assessment was not completed for 4 positions. As a result, a total of 255 positions are included in the Plaque analysis.
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.
Outcome measures
| Measure |
ATLANTIS Abutment
n=255 Positions
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Presence of Plaque
|
96 Positions
|
SECONDARY outcome
Timeframe: Minium of 2 years and a maximum of 8 years of use.Population: 144 subjects (263 implant positions) were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled giving a per protocol population of 142 subjects (259 positions) . PPD assessment was not completed for 4 positions. As a result, a total of 255 positions are included in the PPD analysis.
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.
Outcome measures
| Measure |
ATLANTIS Abutment
n=255 Position
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
|
3.11 Millimeter
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Minium of 2 years and a maximum of 8 years of use.Population: 144 subjects (263 implant positions) were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled giving a per protocol population of 142 subjects (259 positions) . PPD assessment was not completed for 4 positions. As a result, a total of 255 positions are included in the PPD analysis.
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.
Outcome measures
| Measure |
ATLANTIS Abutment
n=255 Positions
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP
|
124 Positions
|
SECONDARY outcome
Timeframe: Minium of 2 years and a maximum of 8 years of use.Population: Per protocol population is 142 subjects (259 positions) . For 39 subjects (94 positions) there were no baseline radiographs available for analysis. As a result, a total of 165 positions are included in the analysis of MBL 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.
Outcome measures
| Measure |
ATLANTIS Abutment
n=103 Participants
ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
|
|---|---|
|
Marginal Bone Level Change
|
-0.30 Millimeter
Standard Deviation 0.93
|
Adverse Events
ATLANTIS Abutment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Manager Global Clinical Research
Dentsply Sirona Implants, Mölndal, SWEDEN
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60