Jaw, Edentulous, Partially
Conditions
Brief summary
The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
Interventions
DEVICEASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
DEVICE3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent * Age 18 - 75 years * Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid * Edentulous in the area/s if implant placement for more than 2 months
Exclusion criteria
* Untreated caries and/or periodontal disease of residual dentition * Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s. * Absence of occlusal stability in centric occlusion * Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * Pregnancy * Present alcohol or drug abuse * Tobacco smoking during the last 6 months * Unable or unwilling to return for follow-up visits for a period of 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level Changes | 3 years after implant placement (baseline) | 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 the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ASTRA TECH Implant System; Fixture ST Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. | 18 |
| Biomet 3i; Osseotite® Implants Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | ASTRA TECH Implant System; Fixture ST | Biomet 3i; Osseotite® Implants | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 12 | 51 years STANDARD_DEVIATION 11 | 53 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 1 / 18 | 1 / 18 |
Outcome results
Primary
Marginal Bone Level Changes
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 the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
Time frame: 3 years after implant placement (baseline)
Population: Per protocol analysis presented and this includes 86 implants in 36 patients. At 3-year follow-up, 74 implants in 31 patients were still in the study and thus evaluable for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASTRA TECH Implant System; Fixture ST | Marginal Bone Level Changes | -0.25 millimeter | Standard Deviation 0.6 |
| Biomet 3i; Osseotite® Implants | Marginal Bone Level Changes | -0.50 millimeter | Standard Deviation 0.93 |