Complete Edentulism, Partial Edentulism
Conditions
Keywords
Short implants, prospective multicenter study, maxilla & mandible
Brief summary
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.
Detailed description
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: * cumulative survival rates of the implants * soft tissue parameters (papilla index, bleeding on probing) * plaque formation
Interventions
DEVICEShorty implants
Dental implant insertion to maxilla or mandible
Sponsors
Nobel Biocare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm. * The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm. * The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization. * Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion. * The implants site(s) should be free from extraction remnants. * The subject should be healthy and compliant with good oral hygiene. * The subject should be available for the 5-year term of the investigation. * Favorable and stable occlusal relationship
Exclusion criteria
* Alcohol or drug abuse as noted in patient records or in patient history. * Health conditions, which do not permit the surgical procedure. * Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history. * The subject is not able to give her/his informed consent to participate. * Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation. * Severe bruxism or other destructive habits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Remodeling | from implant insertion to 6, 12, 36 and 60 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Survival Rates of the Implants | implant insertion to follow-up visits (6, 12, 36 and 60 months) | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shorty Implants Brånemark System Mk III Shorty and/or NobelSpeedy Shorty
Shorty implants: Dental implant insertion to maxilla or mandible | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Shorty Implants |
|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 4.39 |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
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.
Time frame: from implant insertion to 6, 12, 36 and 60 months
Population: Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shorty Implants | Marginal Bone Remodeling | implant insertion to 6 months | -1.34 mm | Standard Deviation 1.1 |
| Shorty Implants | Marginal Bone Remodeling | implant insertion to 12 months | -1.38 mm | Standard Deviation 1.12 |
| Shorty Implants | Marginal Bone Remodeling | implant insertion to 36 months | -1.37 mm | Standard Deviation 1.02 |
| Shorty Implants | Marginal Bone Remodeling | implant insertion to 60 months | -1.65 mm | Standard Deviation 1.11 |
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).
Time frame: implant insertion to follow-up visits (6, 12, 36 and 60 months)
Population: Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shorty Implants | Cumulative Survival Rates of the Implants | 60 months | 96.5 percentage of surviving implants |
| Shorty Implants | Cumulative Survival Rates of the Implants | 36 months | 97.7 percentage of surviving implants |
| Shorty Implants | Cumulative Survival Rates of the Implants | 12 months | 98.8 percentage of surviving implants |
| Shorty Implants | Cumulative Survival Rates of the Implants | 6 months | 98.8 percentage of surviving implants |