Jaw, Edentulous, Partially
Conditions
Keywords
Jaw, Edentulous, Partially (posterior mandible)
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 mandible 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 mandible, Kennedy class I or class 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. * 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 will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants. |
| Implant Stability | At 1 year follow-up | Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. |
| Marginal Bone Adaptation | At 5 year follow-up | Marginal bone adaptation will be 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 will be 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. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | OsseoSpeed |
|---|---|
| Age Continuous | 57 years STANDARD_DEVIATION 10 |
| Region of Enrollment Germany | 15 participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 17 / 45 |
Outcome results
Primary
Implant Stability
Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.
Time frame: At 1 year follow-up
Population: Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed | Implant Stability | 77.4 ISQ | Standard Deviation 7.1 |
Primary
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be 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 (134 implants in 44 patients).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OsseoSpeed | Implant Survival Rate | 100 Percentage of implants |
Primary
Marginal Bone Adaptation
Marginal bone adaptation will be 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 will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
Time frame: At 5 year follow-up
Population: Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed | Marginal Bone Adaptation | -0.05 Millimeter | Standard Deviation 1.96 |