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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATLANTIS Abutment | The investigational product (ATLANTIS abutment) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATLANTIS Abutment | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Minium of 2 years and a maximum of 8 years of use. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Having received one or more ATLANTIS abutments included in one or more permanent prosthetic restoration(s):
Being at least 18 years at day of enrollment
Having signed and dated the informed consent form
Exclusion Criteria:
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The study population is individuals who received ATLANTIS abutments, between 2010 and 2013, connected to implants from BIOMET 3i, Straumann, Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System) replacing one or more teeth, in any position in the mouth, as part of a permanent prosthetic restoration. The partially dentate individuals have received either single-unit crowns or fixed partial or full dentures. The abutments need to be titanium or gold-shaded titanium.
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| Name | Affiliation | Role |
|---|---|---|
| Dr Ingeborg J. Dr De Kok, DDS | University of North Carolina, School of Dentistry, Chapel Hill, NC 27599, US | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, Division of Prosthodontics | Birmingham | Alabama | 35294-0007 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | ATLANTIS Abutment | ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ATLANTIS Abutment | ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | 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. | Posted | Count of Units | Abutments | Minium of 2 years and a maximum of 8 years of use. | Abutments | Abutments |
|
Minium of 2 years and a maximum of 8 years
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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 | ATLANTIS Abutment | ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Research | Dentsply Sirona Implants, Mölndal, SWEDEN | 0046313763500 | ClinicalResearchMolndal@dentsplysirona.com |
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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 6, 2014 | Dec 4, 2019 | Prot_SAP_000.pdf |
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| Minium of 2 years and a maximum of 8 years of use. |
| 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. | Minium of 2 years and a maximum of 8 years of use. |
| 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. | Minium of 2 years and a maximum of 8 years of use. |
| 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. | Minium of 2 years and a maximum of 8 years of use. |
| 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. | Minium of 2 years and a maximum of 8 years of use. |
| University of California, Los Angeles, School of Dentistry |
| Los Angeles |
| California |
| 90095 |
| United States |
| Nova Southeastern University, College of Dental Medicine | Fort Lauderdale | Florida | 33328 | United States |
| University of Iowa, College of Dentistry | Iowa City | Iowa | 52242 | United States |
| Columbia University, College of Dental Medicine | New York | New York | 10032 | United States |
| University of North Carolina, School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
| Abutments |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Abutments |
|
|
|
| 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. | 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). | Posted | Count of Units | Abutments | Minium of 2 years and a maximum of 8 years of use. | Abutments | Abutments |
|
|
|
| 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. | 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. | Posted | Count of Units | Positions | Minium of 2 years and a maximum of 8 years of use. | Positions | 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. | 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. | Posted | Mean | Standard Deviation | Millimeter | Minium of 2 years and a maximum of 8 years of use. | Position | Position |
|
|
|
| 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. | 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. | Posted | Count of Units | Positions | Minium of 2 years and a maximum of 8 years of use. | Positions | Positions |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Millimeter | Minium of 2 years and a maximum of 8 years of use. |
|
|
|
| 0 |
| 142 |
| 0 |
| 142 |
| 0 |
| 142 |
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