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The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement
The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Submerged healing | Active Comparator | The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment |
|
| Trans-mucosal healing | Active Comparator | The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straumann Bone Level Implant | Device | Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) | The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | The percentage of implants that remain in place in the jaw. | 6 months |
| Implant Survival Rate | The percentage of implants that remain in place in the jaw. |
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Inclusion Criteria:
Exclusion Criteria:
Secondary Exclusion Criteria at Implant Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Hammerle | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Jeffery Ganeles | Boca Raton | Florida | 33431 | United States | ||
| Dr. William C. Martin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21722188 | Result | Hammerle CHF, Jung RE, Sanz M, Chen S, Martin WC, Jackowski J; this multicenter study group; Ivanoff CJ, Cordaro L, Ganeles J, Weingart D, Wiltfang J, Gahlert M. Submerged and transmucosal healing yield the same clinical outcomes with two-piece implants in the anterior maxilla and mandible: interim 1-year results of a randomized, controlled clinical trial. Clin Oral Implants Res. 2012 Feb;23(2):211-219. doi: 10.1111/j.1600-0501.2011.02210.x. Epub 2011 Jul 4. | |
| 22697581 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Submerged Healing | The dental implants will be placed using a submerged healing treatment |
| FG001 | Trans-mucosal Healing | The dental implants will be placed using a trans-mucosal healing treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 12 months |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Dr. Stephen T. Chen | Melbourne | 3123 | Australia |
| Prof. Wiltfang | Kiel | Schleswig-Holstein | 24105 | Germany |
| Michael Gahlert | München | 80333 | Germany |
| Katharinenhospital | Stuttgart | 70174 | Germany |
| Private Universität Witten/ Herdecke | Witten/ Herdecke | Germany |
| Dr. Luca Cordaro | Rome | 00198 | Italy |
| Prof. Mariano Sanz | Madrid | 28040 | Spain |
| Dr. Carl-Johan Ivanoff | Mölndal | 43180 | Sweden |
| Christoph Hämmerle | Zurich | 8032 | Switzerland |
| Result |
| Cordaro L, Torsello F, Chen S, Ganeles J, Bragger U, Hammerle C. Implant-supported single tooth restoration in the aesthetic zone: transmucosal and submerged healing provide similar outcome when simultaneous bone augmentation is needed. Clin Oral Implants Res. 2013 Oct;24(10):1130-6. doi: 10.1111/j.1600-0501.2012.02521.x. Epub 2012 Jun 15. |
| 6 Months |
|
| 1 Year |
|
| 2 Year |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Submerged Healing | The dental implants will be placed using a submerged healing treatment |
| BG001 | Trans-mucosal Healing | The dental implants will be placed using a trans-mucosal healing treatment |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) | The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder. | ITT population | Posted | Jun 2011 | Mean | Standard Deviation | millimeters | Baseline and 6 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Implant Survival Rate | The percentage of implants that remain in place in the jaw. | Posted | Jun 2011 | Number | % of implants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Implant Survival Rate | The percentage of implants that remain in place in the jaw. | Posted | Jun 2011 | Number | % of implants | 12 months |
|
|
6 Months
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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 | Submerged Healing | The dental implants will be placed using a submerged healing treatment | 2 | 73 | 8 | 73 | ||
| EG001 | Trans-mucosal Healing | The dental implants will be placed using a trans-mucosal healing treatment | 0 | 72 | 10 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine Cancer | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant or site related complications | General disorders | Non-systematic Assessment |
| ||
| Implant mobility | General disorders | Non-systematic Assessment |
| ||
| Dehiscence at implant site | General disorders | Non-systematic Assessment |
| ||
| Gingival/Mucosal Problems | General disorders | Non-systematic Assessment |
| ||
| Fistula | General disorders | Non-systematic Assessment |
| ||
| Prosthetic Related Complications | General disorders | Non-systematic Assessment |
| ||
| Lost/Failure (fracture) of an Abutment | General disorders | Non-systematic Assessment |
| ||
| Loosening of Occlusal Screw | General disorders | Non-systematic Assessment |
| ||
| Aesthetic Problems | General disorders | Non-systematic Assessment |
| ||
| Failure of Prosthetic Part (framework) | General disorders | Non-systematic Assessment |
| ||
| Acrylic or Porcelain Fractures | General disorders | Non-systematic Assessment |
| ||
| Uterine Cancer | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Local discomfort/pain around the implant site | General disorders | Non-systematic Assessment |
| ||
| Allergic reaction | General disorders | Non-systematic Assessment |
| ||
| Membrane Exposure | General disorders | Non-systematic Assessment |
| ||
| Hyperthyreosis | Endocrine disorders | Non-systematic Assessment |
| ||
| General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Hotze, PhD | Institut Straumann | +4161965 | 1235 | michael.hotze@straumann.com |
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
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| >=65 years |
|
| Male |
|
| Spain |
|
| Australia |
|
| Germany |
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| Switzerland |
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| Italy |
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| Sweden |
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