Immediate vs Delayed Dental Implant Placement for Tooth Loss

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institut Straumann AG

Must not be taking: Antiresorptive agents

Disqualifiers: Systemic disease, Mucosal diseases, Untreated periodontal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

53 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving intravenous or subcutaneous antiresorptive agents like bisphosphonates, you may not be eligible to participate.

What data supports the effectiveness of the treatment Straumann Bone Level Tapered Implant for immediate vs delayed dental implant placement?

Research shows that immediate dental implant placement results in less bone loss compared to delayed placement. Additionally, studies indicate that fully tapered implants used for immediate placement have high success rates and maintain good bone stability, making them effective for replacing missing teeth. ^{1 2 3 4 5}

Is immediate or delayed dental implant placement safe for humans?

Research shows that immediate dental implant placement using Straumann tapered implants is generally safe, with studies reporting a 100% implant survival rate and successful integration in patients over a 1-year period. ^{3 4 5 6 7}

How does immediate dental implant placement differ from delayed placement for tooth loss?

Immediate dental implant placement is unique because it involves placing the implant right after tooth extraction, which reduces the number of surgeries and overall treatment time. This approach also results in less bone loss compared to delayed placement, where the implant is placed 1-2 months after extraction, leading to more significant bone volume loss over time. ^{1 2 3 4 8}

Research Team

David L. Cochran, DDS, PhD, MS

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

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.

Inclusion Criteria

Subjects must have voluntarily signed the informed consent form before any study related procedures

Subjects must be committed to the study and the required follow-up visits.

My bone is thick enough for a stable implant.

Exclusion Criteria

Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implant Placement

Implant is placed at the time of tooth extraction or after 16-18 weeks of healing

Immediate or 16-18 weeks

1 visit (in-person)

Loading

Implant loading occurs 10-12 weeks after implant surgery

10-12 weeks post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for clinical and radiographic outcomes, including implant success and survival, up to 12 months post-loading

12 months

Multiple visits (in-person)

Long-term Follow-up

Long-term monitoring of clinical and radiographic outcomes, including subject satisfaction and adverse events, up to 60 months post-loading

24, 36, 48, and 60 months post-loading

Treatment Details

Interventions

• Straumann Bone Level Tapered Implant - Delayed Placement
• Straumann Bone Level Tapered Implant - Immediate Placement

Trial Overview 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.

Participant Groups

Group I: Immediate Placement - Test Experimental Treatment 1 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 - Control Experimental Treatment 1 Intervention

Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.

Who Is Running the Clinical Trial?

Institut Straumann AG

Lead Sponsor

Trials

54

Recruited

2,700+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Different Timings of Implant Insertion on the Bone Remodeling Volume around Patients' Maxillary Single Implants: A 2-3 Years Follow-Up. [2020]

2. Denmark pubmed.ncbi.nlm.nih.gov

Immediate loading of a fully tapered implant with deep apical threads placed in healed alveolar ridges vs. immediate extraction sockets. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Immediate Implant Placement in the Esthetic Zone Using a Novel Tapered Implant Design and a Digital Integrated Workflow: A Case Series. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical and Radiologic Evaluation of a Fully Tapered Implant with Immediate Placement in the Esthetic Zone: A Prospective Case Series Study. [2022]

5. Egypt pubmed.ncbi.nlm.nih.gov

Immediate Placement and Restoration of a New Tapered Implant System in the Aesthetic Region: A Report of Three Cases. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

An experimental study on the effects of the cortical thickness and bone density on initial mechanical anchorage of different Straumann® implant designs. [2021]

7. Denmark pubmed.ncbi.nlm.nih.gov

Immediate and early loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: 1-year results from a prospective multicenter study. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Immediate dental implant placement with immediate loading following extraction of natural teeth. [2020]