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To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Immediate loading | Experimental | Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing |
|
| Immediate loading | Other | Historic cohort subjected to immediate loading |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate loading, fully guided surgery and 3D printed restoration | Procedure | Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Implant Survival | Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction | 12 months |
| MBL | Marginal bone loss MBL, measured in mm from implant abutment junction. | 12 months |
| Pink Esthetic Score | Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome. | 12 months |
| White Esthetic Score | White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome. | 12 months |
| Oral Health Impact Profile - 14 | Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Wennerberg, PhD | Göteborg University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Dental Specialist Care | Lund | Skåne County | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Immediate Loading | Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded. |
| FG001 | Immediate Loading | Immediate loading: Only subjected to immediate loading. Conventional procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Immediate Loading | Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded. |
| 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 | Number of Participants With Implant Survival | Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction | Posted | Number | participants | 12 months |
|
1 year
Serious events: loss of dental implant. Other adverse event: prosthetic restoration complications.
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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 | Digital Immediate Loading | Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental implant loss | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Björn Gjelvold | Folktandvården Skåne AB | +46709467870 | bjorn.gjelvold@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2015 | Feb 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2019 | Mar 13, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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| Immediate loading | Procedure | Only subjected to immediate loading. Conventional procedure. |
|
| BG001 | Immediate Loading | Immediate loading: Only subjected to immediate loading. Conventional procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
|
| Primary | MBL | Marginal bone loss MBL, measured in mm from implant abutment junction. | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
|
| Primary | Pink Esthetic Score | Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Primary | White Esthetic Score | White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Primary | Oral Health Impact Profile - 14 | Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 0 |
| 21 |
| 2 |
| 21 |
| 0 |
| 21 |
| EG001 | Immediate Loading | Immediate loading: Only subjected to immediate loading. Conventional procedure. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |