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Dental Implant

Dental Implant Healing Times for Tooth Loss

N/A

Waitlist Available

Led By Christopher Barwacz, DDS

Research Sponsored by Christopher Barwacz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with a healed, single-rooted tooth (except mandibular incisors) that has previously undergone ARP-SG with anorganic bovine bone mineral graft

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years post implant loading

Awards & highlights

Study Summary

This trial is comparing different time intervals for healing before getting an implant. Subjects will visit the University of Iowa College of Dentistry 9 times over 42-48 months.

Who is the study for?

This trial is for adults with a healed single-rooted tooth (except lower front teeth) that's had bone grafting. They must be healthy enough for dental procedures, have signed consent, and commit to multiple visits at the University of Iowa College of Dentistry. Pregnant women, nursing mothers, or those with severe bone diseases or on certain medications affecting bone metabolism cannot participate.Check my eligibility

What is being tested?

The study evaluates the AstraTech Implant System Evolution implants' stability and tissue outcomes over three years when immediately fitted with a temporary crown after grafting. Participants will undergo various assessments including oral hygiene checks and pain evaluation across nine visits spanning up to four years.See study design

What are the potential side effects?

Potential side effects may include discomfort or pain from dental procedures, infection risks around the implant site, inflammation of gums, bleeding during probing of gums, possible recession of gum tissue around the implant area, and issues related to occlusion (bite) adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tooth (not a lower front tooth) that was treated with a specific bone graft.

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My teeth near the implant site are healthy and free from major dental issues.

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I am getting a dental implant to replace my extracted tooth.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years post implant loading

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years post implant loading

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post implant loading for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Implant survival

Secondary outcome measures

% of vital bone via histomorphotmetric evaluation of bone core biopsies at 3 months

% of vital bone via histomorphotmetric evaluation of bone core biopsies at 6 months

% of vital bone via histomorphotmetric evaluation of bone core biopsies at 9 months

+1 more

Trial Design

3Treatment groups

Active Control

Group I: Group 1Active Control21 Interventions

Group 1: 3 months post-ARP-SG and dental implant placement using Azento® with an Astra Tech Implant® EV implant and immediate implant provisionalization using Azento®. At 3 months post-DIP&P, a definitive all-ceramic crown, fabricated using a digital workflow (CoreFile), will be placed

Group II: Group 3Active Control22 Interventions

Group 3: 9 months post-ARP-SG and dental implant placement using Azento® with an Astra Tech Implant® EV implant and immediate implant provisionalization using Azento®. At 3 months post-DIP&P, a definitive all-ceramic crown, fabricated using a digital workflow (CoreFile), will be placed

Group III: Group 2Active Control22 Interventions

Group 2: at 6 months post-ARP-SG and dental implant placement using Azento® with an Astra Tech Implant® EV implant and immediate implant provisionalization using Azento®. At 3 months post-DIP&P, a definitive all-ceramic crown, fabricated using a digital workflow (CoreFile), will be placed.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Christopher BarwaczLead Sponsor

3 Previous Clinical Trials

130 Total Patients Enrolled

Christopher Barwacz, DDSPrincipal InvestigatorUniversity of Iowa

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

AstraTech Implant System (ATIS) Evolution (EV) implants (Dental Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04255342 — N/A

Tooth Loss Research Study Groups: Group 1, Group 3, Group 2

Tooth Loss Clinical Trial 2023: AstraTech Implant System (ATIS) Evolution (EV) implants Highlights & Side Effects. Trial Name: NCT04255342 — N/A

AstraTech Implant System (ATIS) Evolution (EV) implants (Dental Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04255342 — N/A

Tooth Loss Patient Testimony for trial: Trial Name: NCT04255342 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively seeking participants?

"From the data hosted on clinicaltrials.gov, it appears that recruitment for this particular trial has concluded as of June 23rd 2022. Although no longer accepting candidates to this study, there are 33 other medical studies which currently have open slots available."

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