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Immediate vs Delayed Dental Implant Placement for Tooth Loss
N/A
Waitlist Available
Led By David L. Cochran, DDS, PhD, MS
Research Sponsored by Institut Straumann AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be males or females who are a minimum of 18 years of age
Subjects who are in need of a single tooth extraction in the pre-molar or anterior region of the maxilla or mandible (ADA tooth positions 4-13 and 20-29) and replacement with a dental implant.
Must not have
Any implant sites where there will be a buccal dehiscence greater than 3 mm or there will be a fenestration of the implant
Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew tobacco
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 24, 36, 48 and 60 months post-loading
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a dental implant that can be placed soon after a tooth is removed. It focuses on patients who need extractions in specific areas of their jaws. The goal is to see if this placement helps maintain bone levels and provides stable support for new teeth. This method was introduced to limit bone loss and reduce the number of surgical procedures following tooth extraction.
Who is the study for?
Adults needing a single tooth extraction and implant in the front or premolar area of their upper or lower jaw, with healthy adjacent teeth and sufficient bone for stability. Participants must be in good health, able to perform oral hygiene, not pregnant, non-heavy smokers (less than 10 cigarettes/day), without severe bruxism or TMJ issues, and committed to follow-up visits.
What is being tested?
The study compares outcomes of placing Straumann Bone Level Tapered implants immediately after tooth extraction versus delayed placement in healed sites. It's randomized and controlled across multiple centers to assess clinical performance and x-ray results.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with dental implant surgery such as infection, swelling, pain at the implant site, bleeding, nerve damage leading to numbness or tingling sensation, and possible failure of the implant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old.
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I need a tooth removed and replaced with an implant in the front part of my mouth.
Select...
I have natural teeth next to where my implant will go.
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I have opposing teeth, whether natural or with dental work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My dental implant site has a gap or hole larger than 3 mm.
Select...
I smoke more than 10 cigarettes or 1 cigar a day, or I use chewing tobacco.
Select...
I have severe teeth grinding or jaw problems.
Select...
I cannot have surgery in my mouth due to health risks.
Select...
I have untreated gum disease or tooth root issues near where my implant will go.
Select...
I have a condition that makes dental implant surgery unsafe for me.
Select...
I have a condition that makes it hard for me to take care of my dental health.
Select...
I have received IV or under-the-skin medication for bone loss.
Select...
I have had radiation therapy in my head or neck area.
Select...
I have a skin condition like erosive lichen planus near where the study device will be placed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 24, 36, 48 and 60 months post-loading
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 24, 36, 48 and 60 months post-loading
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean crestal bone level change
Secondary study objectives
Buccal bone dimensional changes
Change in implant stability
Change in soft tissue - gingival margin
+7 moreOther study objectives
Buccal bone dimensional changes over long term
Change in soft tissue - gingival margin over long term
Change in soft tissue - papilla margin over long term
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Immediate Placement - TestExperimental Treatment1 Intervention
Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.
Group II: Delayed Placement - ControlExperimental Treatment1 Intervention
Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Dental implants, such as the Straumann® Bone Level Tapered implant, are a common treatment for tooth loss. These implants act as artificial tooth roots, providing a stable foundation for dental prosthetics like crowns, bridges, or dentures.
The implant is surgically placed into the jawbone, where it undergoes osseointegration, a process where the bone fuses with the implant, ensuring stability and durability. This is crucial for tooth loss patients as it restores functionality, improves aesthetics, and prevents bone loss that can occur when teeth are missing.
Immediate implantation can be done right after tooth extraction, while delayed implantation is performed after the site has healed, offering flexibility based on the patient's condition.
Prognostic factors affecting periodontal regenerative therapy using recombinant human fibroblast growth factor-2: A 3-year cohort study.
Prognostic factors affecting periodontal regenerative therapy using recombinant human fibroblast growth factor-2: A 3-year cohort study.
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Who is running the clinical trial?
Institut Straumann AGLead Sponsor
53 Previous Clinical Trials
2,616 Total Patients Enrolled
8 Trials studying Tooth Loss
431 Patients Enrolled for Tooth Loss
David L. Cochran, DDS, PhD, MSPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Subjects must be committed to the study and the required follow-up visits.My dental implant site has a gap or hole larger than 3 mm.My bone is thick enough for a stable implant.I smoke more than 10 cigarettes or 1 cigar a day, or I use chewing tobacco.I have severe teeth grinding or jaw problems.I have opposing teeth, whether natural or with dental work.I cannot have surgery in my mouth due to health risks.I am at least 18 years old.I have untreated gum disease or tooth root issues near where my implant will go.I have a condition that makes dental implant surgery unsafe for me.I need a tooth removed and replaced with an implant in the front part of my mouth.I have natural teeth next to where my implant will go.I have a condition that makes it hard for me to take care of my dental health.I have received IV or under-the-skin medication for bone loss.I have had radiation therapy in my head or neck area.I have a skin condition like erosive lichen planus near where the study device will be placed.My dental implant will be placed right after tooth removal or in a healed area not grafted before.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Placement - Test
- Group 2: Delayed Placement - Control
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: NCT02569671 — N/A
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