Study Results
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-01-29
Study Completion Date
2024-01-30
Brief Summary
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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.
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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Detailed Description
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Conditions
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Tooth Loss
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery
Group Type
EXPERIMENTAL
Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery
Intervention Type
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.
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Subjects may identify as either male, female, or intersex
* Age: 18 years or older
* Subjects with a healed, single-rooted tooth (except mandibular incisors) that has previously undergone ARP-SG with particulate allograft material within the past 2 months.
* Subjects must have stable occlusion, with absence of caries or other known acute pathology (i.e., untreated endodontic lesion, periodontal abscess, external/internal resorption, etc.) on teeth proximal to the implant site that would negatively influence implant outcomes
* Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
* Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
* Subjects must have read, understood and signed an informed consent form
* Subjects must be willing to return for the required number of visits
* Subjects' tooth must be a permanent tooth, not a primary tooth (also known as baby tooth).
* Age: 18 years or older
* Subjects with a healed, single-rooted tooth (except mandibular incisors) that has previously undergone ARP-SG with particulate allograft material within the past 2 months.
* Subjects must have stable occlusion, with absence of caries or other known acute pathology (i.e., untreated endodontic lesion, periodontal abscess, external/internal resorption, etc.) on teeth proximal to the implant site that would negatively influence implant outcomes
* Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
* Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
* Subjects must have read, understood and signed an informed consent form
* Subjects must be willing to return for the required number of visits
* Subjects' tooth must be a permanent tooth, not a primary tooth (also known as baby tooth).
Exclusion Criteria
* Mandibular incisors
* Acute infection associated with the tooth to be extracted or with adjacent teeth
* Unstable occlusion, presence of caries or other acute pathology on teeth adjacent to the implant site
* History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use \[\>10 cigs/day\]), history of head/neck radiation, history of chemotherapy within the last 5 years
* Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
* Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
* Pregnant women or nursing mothers
* Subjects that are unwilling or unable to sign the informed consent
* History of lack of compliance with dental visits
* Subjects unwilling to return for the required number of visits
* Subject currently undergoing orthodontic treatment
* Acute infection associated with the tooth to be extracted or with adjacent teeth
* Unstable occlusion, presence of caries or other acute pathology on teeth adjacent to the implant site
* History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use \[\>10 cigs/day\]), history of head/neck radiation, history of chemotherapy within the last 5 years
* Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
* Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
* Pregnant women or nursing mothers
* Subjects that are unwilling or unable to sign the informed consent
* History of lack of compliance with dental visits
* Subjects unwilling to return for the required number of visits
* Subject currently undergoing orthodontic treatment
Minimum Eligible Age
18 Years
Maximum Eligible Age
95 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Christopher Barwacz
OTHER
Sponsor Role
lead
Responsible Party
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Christopher Barwacz
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Christopher Barwacz, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa
Iowa City, Iowa, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Barwacz, C. & Hernandez, M. (2013) Maximizing Esthetics of Fixed Interim Restorations via Direct Extrinsic Characterization. Journal of Cosmetic Dentistry 29, 122-131.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201911024
Identifier Type: -
Identifier Source: org_study_id
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