| Primary | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | | This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants. | Posted | | Mean | Standard Deviation | mm | | Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery | Implants | Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
| | Units | Counts |
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| Participants | | | Implants | |
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.82± 0.89
- OG0010.56± 0.73
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| Primary | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | | This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants. | Posted | | Mean | Standard Deviation | mm | | Change in crestal bone level from surgery (baseline) to 1 year post-surgery | Implants | Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Primary | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | | This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants. | Posted | | Mean | Standard Deviation | mm | | Change in crestal bone level from surgery (baseline) to 2 years post-surgery | Implants | Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Primary | Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. | | This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants. | Posted | | Mean | Standard Deviation | mm | | Change in crestal bone level from surgery (baseline) to 3 years post-surgery | Implants | Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Implant Survival | Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation | | Posted | | Number | | implants | | 20-23 Weeks post-surgery | Implants | Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Implant Survival | Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation | Number of implants placed. Implants from drop-outs are not included | Posted | | Number | | implants | | 1 year post-surgery | Number of implants | Number of implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Implant Survival | Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation | | Posted | | Number | | implants | | 2 years post-surgery | Number of Implants | Number of Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Implant Survival | Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation | | Posted | | Number | | implants | | 3 years post-surgery | Number of Implants | Number of Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected | Patients affected by AE Patients affected by related/ unknown AE | All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled | Posted | | Number | | patients affected | | until the 3 year post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Implant Success | Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant | | Posted | | Number | | implants | | 20-23 weeks post-surgery | Number of Implants | Number of Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Implant Success | Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant | | Posted | | Number | | implants | | 1 years post-surgery | Number of Implants | Number of Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Implant Success | Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant | The analysis was based on implants as observational unit. The 2-year data was analyzed together with the 3-year data. Our statistical analysis for 2-year time point included how many implants were available but not how many participants. | Posted | | Number | | implants | | 2 years post-surgery | Number of Implants | Number of Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Implant Success | Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant | | Posted | | Number | | implants | | 3 years post-surgery | Number of Implants | Number of Implants | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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| Secondary | Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events | Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs) | All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled | Posted | | Number | | number of events | | until the 3 year post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Immediate Loading | Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant | | OG001 | Early Loading | Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant |
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