What side effects are associated with this type of intervention?

Common side effects of dental implants, such as the Straumann® Bone Level Tapered implant, include infection at the implant site, injury or damage to surrounding structures like teeth or blood vessels, nerve damage that can cause pain, numbness, or tingling in natural teeth, gums, lips, or chin, and sinus problems when implants placed in the upper jaw protrude into the sinus cavities. Additionally, there may be discomfort and swelling in the gums and face, minor bleeding, and bruising. Long-term complications can include implant failure due to poor osseointegration or peri-implantitis, an inflammatory condition affecting the soft and hard tissues around the implant.

What prior FDA approvals exist?

The FDA has approved various dental implants for the treatment of tooth loss, which provide a stable foundation for dental prosthetics. These implants, including those similar to the Straumann® Bone Level Tapered implant, are designed for both immediate and delayed implantation scenarios. They are typically made of biocompatible materials like titanium and are used to support crowns, bridges, or dentures, thereby restoring function and aesthetics for patients with missing teeth.

What other types of research exist?

Promising novel alternatives to the Straumann® Bone Level Tapered implant for tooth loss patients in 2024 include: 1) Nobel Biocare's N1™ system, which offers a biologically driven design for enhanced osseointegration and reduced healing times; 2) Dentsply Sirona's Astra Tech Implant System EV, known for its unique OsseoSpeed surface for faster bone integration; and 3) Neodent's Acqua hydrophilic surface implants, which improve initial stability and early bone healing. These alternatives provide stable foundations for dental prosthetics in both immediate and delayed implantation scenarios.

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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 below

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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.

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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:

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My dental implant site has a gap or hole larger than 3 mm.

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I smoke more than 10 cigarettes or 1 cigar a day, or I use chewing tobacco.

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I have severe teeth grinding or jaw problems.

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I cannot have surgery in my mouth due to health risks.

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I have untreated gum disease or tooth root issues near where my implant will go.

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I have a condition that makes dental implant surgery unsafe for me.

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I have a condition that makes it hard for me to take care of my dental health.

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I have received IV or under-the-skin medication for bone loss.

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I have had radiation therapy in my head or neck area.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 24, 36, 48 and 60 months post-loading for reporting.

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 more

Other 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 more

Awards & 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.

0 / 14Eligibility criteria met

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.