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The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance.
The primary endpoint was the change in marginal bone levels (in mm) from the time of implant insertion to follow-up visits (3, 6, 12, 36 and 60 months).
Further endpoints were:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shorty implants | Other | Brånemark System Mk III Shorty and/or NobelSpeedy Shorty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shorty implants | Device | Dental implant insertion to maxilla or mandible |
|
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Remodeling | Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline. Missing data was not imputed and not included in evaluation. | from implant insertion to 6, 12, 36 and 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Survival Rates of the Implants | An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument). |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Shorty Implants | Brånemark System Mk III Shorty and/or NobelSpeedy Shorty Shorty implants: Dental implant insertion to maxilla or mandible |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Shorty Implants | Brånemark System Mk III Shorty and/or NobelSpeedy Shorty Shorty implants: Dental implant insertion to maxilla or mandible |
| 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 | Marginal Bone Remodeling | Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline. Missing data was not imputed and not included in evaluation. | Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation. | Posted | Mean | Standard Deviation | mm | from implant insertion to 6, 12, 36 and 60 months | implants | Participants |
|
Adverse events were collected during the course of the study up to 5-years follow up.
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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 | Shorty Implants | Brånemark System Mk III Shorty and/or NobelSpeedy Shorty Shorty implants: Dental implant insertion to maxilla or mandible |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant mobile | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Trial Management | Nobel Biocare | +41 43 211 42 00 | isabelle.arrighi@nobelbiocare.com |
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| implant insertion to follow-up visits (6, 12, 36 and 60 months) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Cumulative Survival Rates of the Implants | An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument). | Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation. | Posted | Number | percentage of surviving implants | implant insertion to follow-up visits (6, 12, 36 and 60 months) | implants | Participants |
|
|
|
| 0 |
| 38 |
| 9 |
| 38 |
| Implant Out | Surgical and medical procedures | Non-systematic Assessment |
|
| Prosthesis retaining screw fracture | Surgical and medical procedures | Non-systematic Assessment |
|
| Prosthesis retaining screw loosening | Surgical and medical procedures | Non-systematic Assessment |
|
| Hyperplasia | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Swelling | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Moving quick temporary abutment | Surgical and medical procedures | Non-systematic Assessment |
|
| Bridge loosening | Surgical and medical procedures | Non-systematic Assessment |
|
| Phoenetic difficulties | Surgical and medical procedures | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| 6 months |
|