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Sponsor and PI mutual agreement to discontinue study early due to change in statistical analysis of data.
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The revised purpose of this study is to compare and evaluate the stability of the implant body, survival rate, bone-level changes, and the implant's soft-tissue outcomes over a period of 1 year. Only 1 tooth is studied per participant.
In July of 2024, the revised protocol and revised Statistical Analysis plan were amended post-hoc, and the revised protocol and statistical analysis plan were approved by the IRB review committee in July of 2024.
As a result, the study has been terminated due to a change in the study's data analysis, and so the study will only analyze data up to and including the 1-year point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery | Device | At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement. | For participants that had permanent restoration of the final crown performed, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 1 year of having the permanent final crown placement. Note: Only 1 implant was placed per participant. | 1 year after permanent final crown placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Barwacz, DDS | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23845297 | Background | Alkan EA, Parlar A, Yildirim B, Senguven B. Histological comparison of healing following tooth extraction with ridge preservation using enamel matrix derivatives versus Bio-Oss Collagen: a pilot study. Int J Oral Maxillofac Surg. 2013 Dec;42(12):1522-8. doi: 10.1016/j.ijom.2013.06.002. Epub 2013 Jul 8. | |
| 18546808 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery | Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery: At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis population differs from the final results, because 3 subjects were lost to follow-up over the course of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery | Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery: At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed. |
| 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 |
| 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 | Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement. | For participants that had permanent restoration of the final crown performed, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 1 year of having the permanent final crown placement. Note: Only 1 implant was placed per participant. | Posted | Count of Participants | Participants | 1 year after permanent final crown placement |
|
up to 1 year
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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 | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery | Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery: At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Barwacz | University of Iowa | (319) 384-3002 | chris-barwacz@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2024 | Aug 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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|
| Araujo M, Linder E, Wennstrom J, Lindhe J. The influence of Bio-Oss Collagen on healing of an extraction socket: an experimental study in the dog. Int J Periodontics Restorative Dent. 2008 Apr;28(2):123-35. |
| 24621203 | Background | Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12. |
| 20070748 | Background | Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x. |
| 28429394 | Background | Arora H, Khzam N, Roberts D, Bruce WL, Ivanovski S. Immediate implant placement and restoration in the anterior maxilla: Tissue dimensional changes after 2-5 year follow up. Clin Implant Dent Relat Res. 2017 Aug;19(4):694-702. doi: 10.1111/cid.12487. Epub 2017 Apr 21. |
| 24966231 | Background | Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25. |
| 18672985 | Background | Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628. |
| Background | Barwacz, C. & Hernandez, M. (2013) Maximizing Esthetics of Fixed Interim Restorations via Direct Extrinsic Characterization. Journal of Cosmetic Dentistry 29, 122-131. |
| 28572416 | Background | Barwacz CA, Pantzlaff E, Allareddy V, Avila-Ortiz G. Graduate Periodontics Programs' Integration of Implant Provisionalization in Core Curricula: Implementation of CODA Standard 4-10.2.d. J Dent Educ. 2017 Jun;81(6):696-706. doi: 10.21815/JDE.016.033. |
| 30231101 | Background | Barwacz CA, Stanford CM, Diehl UA, Cooper LF, Feine J, McGuire M, Scheyer ET. Pink Esthetic Score Outcomes Around Three Implant-Abutment Configurations: 3-Year Results. Int J Oral Maxillofac Implants. 2018 Sep/Oct;33(5):1126-1135. doi: 10.11607/jomi.6659. |
| 30695089 | Background | Cooper LF, Reside G, Stanford C, Barwacz C, Feine J, Nader SA, Scheyer T, McGuire M. Three-Year Prospective Randomized Comparative Assessment of Anterior Maxillary Single Implants with Different Abutment Interfaces. Int J Oral Maxillofac Implants. 2019 Jan/Feb;34(1):150-158. doi: 10.11607/jomi.6810. |
| 27560668 | Background | Cooper LF, Tarnow D, Froum S, Moriarty J, De Kok IJ. Comparison of Marginal Bone Changes with Internal Conus and External Hexagon Design Implant Systems: A Prospective, Randomized Study. Int J Periodontics Restorative Dent. 2016 Sep-Oct;36(5):631-42. doi: 10.11607/prd.2433. |
| 29513776 | Background | Crespi R, Cappare P, Crespi G, Gastaldi G, Romanos GE, Gherlone E. Tissue Remodeling in Immediate Versus Delayed Prosthetic Restoration in Fresh Socket Implants in the Esthetic Zone: Four-Year Follow-up. Int J Periodontics Restorative Dent. 2018;38(Suppl):s97-s103. doi: 10.11607/prd.3123. Epub 2018 Mar 7. |
| 19302238 | Background | De Rouck T, Collys K, Wyn I, Cosyn J. Instant provisionalization of immediate single-tooth implants is essential to optimize esthetic treatment outcome. Clin Oral Implants Res. 2009 Jun;20(6):566-70. doi: 10.1111/j.1600-0501.2008.01674.x. Epub 2009 Mar 3. |
| 16307569 | Background | Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x. |
| 19040436 | Background | Heberer S, Al-Chawaf B, Hildebrand D, Nelson JJ, Nelson K. Histomorphometric analysis of extraction sockets augmented with Bio-Oss Collagen after a 6-week healing period: a prospective study. Clin Oral Implants Res. 2008 Dec;19(12):1219-25. doi: 10.1111/j.1600-0501.2008.01617.x. No abstract available. |
| 22244384 | Background | Heinemann F, Hasan I, Schwahn C, Bourauel C, Mundt T. Bone level change of extraction sockets with Bio-Oss collagen and implant placement: a clinical study. Ann Anat. 2012 Nov;194(6):508-12. doi: 10.1016/j.aanat.2011.11.012. Epub 2011 Dec 23. |
| 12931761 | Background | Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990. |
| 23163915 | Background | Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19. |
| 12608666 | Background | Kan JY, Rungcharassaeng K, Lozada J. Immediate placement and provisionalization of maxillary anterior single implants: 1-year prospective study. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):31-9. |
| 12747463 | Background | Kan JY, Rungcharassaeng K, Umezu K, Kois JC. Dimensions of peri-implant mucosa: an evaluation of maxillary anterior single implants in humans. J Periodontol. 2003 Apr;74(4):557-62. doi: 10.1902/jop.2003.74.4.557. |
| 9203100 | Background | Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563. |
| 27335267 | Background | Nart J, Barallat L, Jimenez D, Mestres J, Gomez A, Carrasco MA, Violant D, Ruiz-Magaz V. Radiographic and histological evaluation of deproteinized bovine bone mineral vs. deproteinized bovine bone mineral with 10% collagen in ridge preservation. A randomized controlled clinical trial. Clin Oral Implants Res. 2017 Jul;28(7):840-848. doi: 10.1111/clr.12889. Epub 2016 Jun 22. |
| 16515093 | Background | Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29. |
| 26300062 | Background | Noelken R, Oberhansl F, Kunkel M, Wagner W. Immediately provisionalized OsseoSpeed() Profile implants inserted into extraction sockets: 3-year results. Clin Oral Implants Res. 2016 Jun;27(6):744-9. doi: 10.1111/clr.12651. Epub 2015 Aug 24. |
| 21691604 | Background | Ponsi J, Lahti S, Rissanen H, Oikarinen K. Change in subjective oral health after single dental implant treatment. Int J Oral Maxillofac Implants. 2011 May-Jun;26(3):571-7. |
| 21504481 | Background | 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. |
| 26800389 | Background | Roccuzzo M, Gaudioso L, Lungo M, Dalmasso P. Surgical therapy of single peri-implantitis intrabony defects, by means of deproteinized bovine bone mineral with 10% collagen. J Clin Periodontol. 2016 Mar;43(3):311-8. doi: 10.1111/jcpe.12516. Epub 2016 Mar 9. |
| 27617409 | Background | Scheyer ET, Heard R, Janakievski J, Mandelaris G, Nevins ML, Pickering SR, Richardson CR, Pope B, Toback G, Velasquez D, Nagursky H. A randomized, controlled, multicentre clinical trial of post-extraction alveolar ridge preservation. J Clin Periodontol. 2016 Dec;43(12):1188-1199. doi: 10.1111/jcpe.12623. Epub 2016 Oct 21. |
| 19961991 | Background | Spyropoulou PE, Razzoog M, Sierraalta M. Restoring implants in the esthetic zone after sculpting and capturing the periimplant tissues in rest position: a clinical report. J Prosthet Dent. 2009 Dec;102(6):345-7. doi: 10.1016/S0022-3913(09)60189-X. |
| 27447160 | Background | Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869. |
| 24438506 | Background | Strietzel FP, Neumann K, Hertel M. Impact of platform switching on marginal peri-implant bone-level changes. A systematic review and meta-analysis. Clin Oral Implants Res. 2015 Mar;26(3):342-58. doi: 10.1111/clr.12339. Epub 2014 Jan 20. |
| 20664835 | Background | Su H, Gonzalez-Martin O, Weisgold A, Lee E. Considerations of implant abutment and crown contour: critical contour and subcritical contour. Int J Periodontics Restorative Dent. 2010 Aug;30(4):335-43. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |