Jaw, Edentulous, Partially
Conditions
Keywords
Jaw, Edentulous, Partially (posterior maxilla)
Brief summary
The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.
Interventions
DEVICEOsseoSpeed™
OsseoSpeed™, all dimensions
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent * 18 years of age and over * Edentulous in the posterior maxilla, Kennedy classes I or II. Last natural tooth, or previously restored implant in function is canine or first bicuspid. * Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading
Exclusion criteria
* Untreated caries and/or periodontal disease of residual dentition * History of edentulism in the area of implant placement of less than two months * Current need for pre-surgical bone or soft tissue augmentation in the planned implant area. * History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area. * Sinus floor thickness of less than 5 mm, verified by periapical radiographs. * Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * Present alcohol or drug abuse * Unable or unwilling to return for follow-up visits for a period of 5 years * Current use of smoking tobacco * Pregnancy or lactation at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | At 5 year follow-up | An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants. |
| Implant Stability | At 1 year follow-up | Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (\<60) indicate low stability, medium values (60-70) indicate medium stability and high values (\>70) indicate high stability. |
| Marginal Bone Adaptation | At baseline (loading) and at 5 year follow-up | Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss. |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsseoSpeed Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Implant lost | 2 |
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | OsseoSpeed |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 11 |
| Region of Enrollment Germany | 2 participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 3 / 47 |
Outcome results
Primary
Implant Stability
Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (\<60) indicate low stability, medium values (60-70) indicate medium stability and high values (\>70) indicate high stability.
Time frame: At 1 year follow-up
Population: Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed | Implant Stability | 68.3 units on a scale | Standard Deviation 6.7 |
Primary
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Time frame: At 5 year follow-up
Population: Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OsseoSpeed | Implant Survival Rate | 96.25 percentage of implants |
Primary
Marginal Bone Adaptation
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
Time frame: At baseline (loading) and at 5 year follow-up
Population: Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed | Marginal Bone Adaptation | 0.3 Millimeter | Standard Deviation 0.9 |