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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
Must not have
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])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after permanent final crown placement
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I have a tooth (not a lower front tooth) that was treated with a specific bone graft.
Select...
My teeth near the implant site are healthy and free from major dental issues.
Select...
I am getting a dental implant to replace my extracted tooth.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have dental issues near where my implant will be placed.
Select...
I do not have major health issues that could affect treatment or healing.
Select...
I am not on medications that majorly affect bone health.
Select...
I do not have severe bone or thyroid conditions like osteoporosis or Paget's disease.
Select...
I have an infection in or around the tooth that needs to be removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after permanent final crown placement
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after permanent final crown placement
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement.
Secondary study objectives
% 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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown DeliveryExperimental Treatment1 Intervention
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am healthy enough for dental surgery, including tooth removal and implants.I have a tooth (not a lower front tooth) that was treated with a specific bone graft.My teeth near the implant site are healthy and free from major dental issues.I have dental issues near where my implant will be placed.I do not have major health issues that could affect treatment or healing.I am not on medications that majorly affect bone health.I am getting a dental implant to replace my extracted tooth.I am part of the University of Iowa study 201806050 or I identify as male, female, or intersex.I do not have severe bone or thyroid conditions like osteoporosis or Paget's disease.I am willing to attend all required visits.I identify as male, female, or intersex.I am 18 years old or older.I have an infection in or around the tooth that needs to be removed.
Research Study Groups:
This trial has the following groups:- Group 1: Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tooth Loss Patient Testimony for trial: Trial Name: NCT04255342 — N/A
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