Jaw, Edentulous, Partially
Conditions
Keywords
Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))
Brief summary
The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.
Interventions
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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 * A minimum of 20 stable intra occlusal contacts after planned restoration * In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25
Exclusion criteria
* Untreated rampant caries and uncontrolled periodontal disease * Use of smoking tobacco at time of inclusion * History of pre-surgical bone augmentation, within 4 months, in the planned implant area * History of extraction without augmentation, within 3 months in the planned implant area * Absence of opposing dentition * Absence of adjacent (mesial and/or distal) natural tooth * Uncontrolled diabetes * Known pregnancy at time of inclusion * Present alcohol or drug abuse * 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 * Unable or unwilling to return for follow-up visits for a period of 5 years * Unrealistic esthetical demands * Unlikely to be able to comply with study procedures according to Investigators judgment * Already included in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival | 12 months after implant placement | 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. |
Countries
Belgium, Germany, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extraction Sockets Immediate loading of implants placed in extraction sockets.
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. | 55 |
| Healed Ridges Immediate loading of implants placed in healed ridges.
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. | 58 |
| Grafted Sites Immediate loading of implants placed in grafted sites (four months healing after grafting).
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. | 19 |
| Total | 132 |
Baseline characteristics
| Characteristic | Extraction Sockets | Healed Ridges | Grafted Sites | Total |
|---|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 14 | 42 years STANDARD_DEVIATION 15 | 40 years STANDARD_DEVIATION 17 | 42 years STANDARD_DEVIATION 17 |
| Sex: Female, Male Female | 33 Participants | 33 Participants | 7 Participants | 73 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 12 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 58 | 0 / 19 |
| serious Total, serious adverse events | 2 / 55 | 2 / 58 | 0 / 19 |
Outcome results
Primary
Implant Survival
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: 12 months after implant placement
Population: Per protocol analysis presented, this includes implants immediately loaded (Group A: 55 implants in 55 subjects, Group B: 58 implants in 58 subjects, Group C: 19 implants in 19 subjects), of these 5 implants in total failed within 12 months after implant placement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extraction Sockets | Implant Survival | 94.55 percentage of implants |
| Healed Ridges | Implant Survival | 98.28 percentage of implants |
| Grafted Sites | Implant Survival | 94.73 percentage of implants |