Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: A
|
Device: OsseoSpeed™
OsseoSpeed™, all dimensions
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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:
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Untreated caries and/or periodontal disease of residual dentition
-
History of edentulism in the area of implant placement of less than two months
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Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
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History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
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Sinus floor thickness of less than 5 mm, verified by periapical radiographs.
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Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
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Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
-
Present alcohol or drug abuse
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Unable or unwilling to return for follow-up visits for a period of 5 years
-
Current use of smoking tobacco
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Pregnancy or lactation at the time of enrollment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Iowa, College of Dentistry, Dow's Institute for Dental Research | Iowa City | Iowa | United States | 52242-1010 |
2 | UTHSCSA | San Antonio | Texas | United States | 78229 |
3 | Universitetsklinik Mainz, Klinik fur ZMK | Mainz | Germany | D-551 31 |
Sponsors and Collaborators
- Dentsply Sirona Implants
Investigators
- Principal Investigator: James T Mellonig, D.D.S., M.S, University of Texas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YA-OSS-0001
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | OsseoSpeed |
---|---|
Arm/Group Description | 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. |
Period Title: Overall Study | |
STARTED | 47 |
COMPLETED | 36 |
NOT COMPLETED | 11 |
Baseline Characteristics
Arm/Group Title | OsseoSpeed |
---|---|
Arm/Group Description | 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. |
Overall Participants | 32 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
59
(11)
|
Sex: Female, Male (Count of Participants) | |
Female |
19
59.4%
|
Male |
13
40.6%
|
Region of Enrollment (participants) [Number] | |
United States |
30
93.8%
|
Germany |
2
6.3%
|
Outcome Measures
Title | Implant Survival Rate |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | OsseoSpeed |
---|---|
Arm/Group Description | 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. |
Measure Participants | 32 |
Measure Implants | 80 |
Number [percentage of implants] |
96.25
|
Title | Implant Stability |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | OsseoSpeed |
---|---|
Arm/Group Description | 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. |
Measure Participants | 32 |
Measure Implants | 80 |
Mean (Standard Deviation) [units on a scale] |
68.3
(6.7)
|
Title | Marginal Bone Adaptation |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | OsseoSpeed |
---|---|
Arm/Group Description | 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. |
Measure Participants | 27 |
Measure Implants | 68 |
Mean (Standard Deviation) [Millimeter] |
0.3
(0.9)
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | OsseoSpeed | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
OsseoSpeed | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
OsseoSpeed | ||
Affected / at Risk (%) | # Events | |
Total | 3/47 (6.4%) | |
Cardiac disorders | ||
Heart attack | 1/47 (2.1%) | 2 |
Vascular disorders | ||
Subdural hematoma | 1/47 (2.1%) | 1 |
Blod clot in lower leg | 1/47 (2.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
OsseoSpeed | ||
Affected / at Risk (%) | # Events | |
Total | 0/47 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Manager Global Clinical Operations |
---|---|
Organization | DENTSPLY Implants |
Phone | +46313763500 |
- YA-OSS-0001