Tooth LossNCT04255342

Azento IIS 3 Year Outcomes Implant Study

A study testing Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery in people with Tooth Loss, run by Christopher Barwacz at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 95 yearsHealthy volunteers can take part
Conditions the study is for: Tooth Loss
What is being tested?: Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 29 Jan 2020to 30 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 95 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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).

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Clinical, Radiographic, and Histomorphometric Analysis of AstraTech Implant EV Placed and Immediately Provisionalized Into Preserved Alveolar Ridges: A Prospective 3-Year Outcomes Study

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.

Conditions: Tooth Loss
Being tested: Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery
Keywords: alveolar bone, alveolar ridge, bone grafting, bone resorption, dental implant
Medical subject headings: Tooth Loss, Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown DeliveryDevice
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.

Study groups in NCT04255342
Study group	Role	What they receive
Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery	Experimental	Not described Receives: Device: Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year after permanent final crown placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 202030 Jan 2024

First posted5 Feb 2020
Study start29 Jan 2020
Primary completion30 Jan 2024
Study completion30 Jan 2024

Why it stopped: Sponsor and PI mutual agreement to discontinue study early due to change in statistical analysis of data.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Tooth LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04255342
Sponsor's protocol ID: 201911024
Status last verified: Sep 2024
First submitted: 31 Jan 2020
Last updated: 3 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 23845297
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.
PubMed 18546808
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.
PubMed 24621203
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.
PubMed 20070748
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.
PubMed 28429394
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.
PubMed 24966231
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.
PubMed 18672985
Barwacz, C. & Hernandez, M. (2013) Maximizing Esthetics of Fixed Interim Restorations via Direct Extrinsic Characterization. Journal of Cosmetic Dentistry 29, 122-131.
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.
PubMed 28572416
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.
PubMed 30231101
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.
PubMed 30695089
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.
PubMed 27560668
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.
PubMed 29513776
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.
PubMed 19302238
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.
PubMed 16307569

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
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Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
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RecruitingObservational study
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Recruiting
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All Tooth Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical, Radiographic, and Histomorphometric Analysis of AstraTech Implant EV Placed and Immediately Provisionalized Into Preserved Alveolar Ridges: A Prospective 3-Year Outcomes Study
ClinicalTrials.gov ID: NCT04255342
Acronym / sponsor ID: 201911024
Conditions: Tooth Loss
Keywords: alveolar bone, alveolar ridge, bone grafting, bone resorption, dental implant
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor and PI mutual agreement to discontinue study early due to change in statistical analysis of data.
Enrolment: 25 participants (actual)
Lead sponsor: Christopher BarwaczUniversity, hospital or other
Study start: 29 Jan 2020 (actual)
Primary completion: 30 Jan 2024 (actual)
Study completion: 30 Jan 2024 (actual)
First posted: 5 Feb 2020 (actual)
Results: Posted 3 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery	Experimental	Device: Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown DeliveryAt 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.	Device	Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery

Primary outcome

Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement.
Time frame: 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.

Results and safety

Results posted to the registry on 3 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery	25	22

Primary outcome: Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement.

Time frame: 1 year after permanent final crown placement. Count of participants. Unit: Participants

Measure	Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery n = 22
Value	22

Adverse events

Time frame: up to 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23845297Alkan 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.
Background: PubMed 18546808Araujo 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.
Background: PubMed 24621203Araujo 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.
Background: PubMed 20070748Araujo 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.
Background: PubMed 28429394Arora 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.
Background: PubMed 24966231Avila-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.
Background: PubMed 18672985Barone 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.
BackgroundBarwacz, C. & Hernandez, M. (2013) Maximizing Esthetics of Fixed Interim Restorations via Direct Extrinsic Characterization. Journal of Cosmetic Dentistry 29, 122-131.
Background: PubMed 28572416Barwacz 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.
Background: PubMed 30231101Barwacz 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.
Background: PubMed 30695089Cooper 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.
Background: PubMed 27560668Cooper 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.
Individual participant dataSharing planned: No

Related trials for Tooth Loss

Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Recruiting
Effect of Collagen Membrane on Ridge Preservation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher Barwacz, DDS principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery in people with Tooth Loss, run by Christopher Barwacz at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement. (time frame: 1 year after permanent final crown placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04255342, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.