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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extraction Sockets | Experimental | Immediate loading in extraction sockets. |
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| Healed Ridges | Experimental | Immediate loading in healed ridges. |
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| Grafted Sites | Experimental | Immediate loading of implants placed in grafted sites (four months healing after grafting). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTRA TECH Implant System, OsseoSpeed™ | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after implant placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Cooper, Prof, DDS, PhD | School of Dentistry, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry | Chapel Hill | North Carolina | 27599-7450 | United States | ||
| Dental School Department Periodontology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21197501 | Result | Cooper LF, Raes F, Reside GJ, Garriga JS, Tarrida LG, Wiltfang J, Kern M, de Bruyn H. Comparison of radiographic and clinical outcomes following immediate provisionalization of single-tooth dental implants placed in healed alveolar ridges and extraction sockets. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1222-32. | |
| 21504481 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extraction Sockets | Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. |
| FG001 | Healed Ridges |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ghent |
| B-9000 |
| Belgium |
| Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel | Kiel | 241 05 | Germany |
| Universitat Internacional de Catalunya, Department de Odontología | Barcelona | 08190 | Spain |
| Raes F, Cooper LF, Tarrida LG, Vandromme H, De Bruyn H. A case-control study assessing oral-health-related quality of life after immediately loaded single implants in healed alveolar ridges or extraction sockets. Clin Oral Implants Res. 2012 May;23(5):602-8. doi: 10.1111/j.1600-0501.2011.02178.x. Epub 2011 Apr 19. |
| 22469026 | Result | De Bruyn H, Raes F, Cooper LF, Reside G, Garriga JS, Tarrida LG, Wiltfang J, Kern M. Three-years clinical outcome of immediate provisionalization of single Osseospeed() implants in extraction sockets and healed ridges. Clin Oral Implants Res. 2013 Feb;24(2):217-23. doi: 10.1111/j.1600-0501.2012.02449.x. Epub 2012 Apr 2. |
| 24818212 | Result | Cooper LF, Reside GJ, Raes F, Garriga JS, Tarrida LG, Wiltfang J, Kern M, De Bruyn H. Immediate provisionalization of dental implants placed in healed alveolar ridges and extraction sockets: a 5-year prospective evaluation. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):709-17. doi: 10.11607/jomi.3617. |
Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
| FG002 | Grafted Sites | Immediate loading of implants placed in grafted sites (four months healing after grafting). OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of implants | 12 months after implant placement | Implants | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extractions Sockets | Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. | 2 | 55 | 0 | 55 | ||
| EG001 | Healed Ridges | Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. | 2 | 58 | 0 | 58 | ||
| EG002 | Grafted Sites | Immediate loading of implants placed in grafted sites (four months healing after grafting). OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm. | 0 | 19 | 0 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute lymphangitis | Blood and lymphatic system disorders |
| |||
| Prostate cancer | Reproductive system and breast disorders |
| |||
| Lung cancer | Respiratory, thoracic and mediastinal disorders |
| |||
| Stomach cancer | Gastrointestinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Global Clinical Research | DENTSPLY Implants | +46313763500 | clinicalresearchmolndal@dentsply.com |
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
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| Male |
|