Dental Implants
Conditions
Brief summary
The study is designed as a retrospective and multi-center study. The study population is US individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments. The study includes retrospective data collection from the medical records and data collection from one prospective study visit with a clinical examination.The primary objective is to evaluate success. Success is defined as that the study implant and abutment are in situ and no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant tissues are reported during the study.
Interventions
DEVICEATLANTIS Abutment
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having received one or more ATLANTIS abutments included in one or more permanent prosthetic restoration(s): * during 2010, 2011, 2012 or 2013 * made of titanium or gold-shaded titanium * connected to implants from: BIOMET 3i; Straumann; Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System). * Being at least 18 years at day of enrollment * Having signed and dated the informed consent form
Exclusion criteria
* Unable to come for study visit * Not willing to participate in the study or not able to understand the content of the study. * Involvement in the planning and conduct of the study (applies to both DENTSPLY Implants staff and staff at the study site). * Simultaneous participation in another clinical study that may interfere with the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Success Rate | Minium of 2 years and a maximum of 8 years of use. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Position Implant and Abutment Survival | Minium of 2 years and a maximum of 8 years of use. | 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. |
| Presence of Plaque | Minium of 2 years and a maximum of 8 years of use. | 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. |
| Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | Minium of 2 years and a maximum of 8 years of use. | 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. |
| Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP | Minium of 2 years and a maximum of 8 years of use. | 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. |
| Marginal Bone Level Change | Minium of 2 years and a maximum of 8 years of use. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ATLANTIS Abutment ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration. | 142 |
| ATLANTIS Abutment ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration. | 259 |
| Total | 401 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Eligibility criteria not fulfilled | 2 |
Baseline characteristics
| Characteristic | ATLANTIS Abutment |
|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 11.85 |
| Region of Enrollment United States | 142 Participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 142 |
| other Total, other adverse events | 0 / 142 |
| serious Total, serious adverse events | 0 / 142 |
Outcome results
Primary
Overall Success Rate
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ATLANTIS Abutment | Overall Success Rate | 240 Abutments |
Comparison: Only descriptive statistics The implant success rate is analyzed on an implant level (i.e. percent of successful implants) as well as subject level (i.e. percentage of subjects with no unsuccessful implants). This proportion is presented together with a 95% confidence interval (using the exact Binomial approach) and an average follow-up time.95% CI: [88.8, 95.5]
Secondary
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ATLANTIS Abutment | Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP | 124 Positions |
Secondary
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATLANTIS Abutment | Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | 3.11 Millimeter | Standard Deviation 1 |
Secondary
Marginal Bone Level 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATLANTIS Abutment | Marginal Bone Level Change | -0.30 Millimeter | Standard Deviation 0.93 |
Secondary
Presence of Plaque
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ATLANTIS Abutment | Presence of Plaque | 96 Positions |
Secondary
Study Position Implant and Abutment Survival
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.
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ATLANTIS Abutment | Study Position Implant and Abutment Survival | 256 Abutments |