Immediate vs Delayed Dental Implant Placement for Tooth Loss

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for placing dental implants after tooth loss. It compares the immediate placement of the Straumann Bone Level Tapered Implant right after tooth extraction with placement after 16-18 weeks of healing. The trial focuses on individuals needing a single tooth replacement in the front and pre-molar areas of the upper and lower jaw. Ideal participants have healthy neighboring teeth, no major oral health issues, and are prepared to commit to follow-ups.

As an unphased trial, this study allows participants to contribute to dental research and potentially benefit from advanced implant techniques.

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 prior data suggests that this dental implant technique is safe?

Research has shown that the Straumann Bone Level Tapered Implant is generally safe and effective for dental use. Studies have found this implant to be a reliable choice for small gaps between teeth due to its 2.9 mm diameter design. It can be used immediately after tooth extraction, as it fits securely into the bone socket. This secure fit helps maintain implant stability, reducing the risk of complications.

The implant is approved for both single-tooth and multiple-tooth applications, confirming its safety. Although specific side effects are not detailed, its use in various dental procedures supports its safety.

Overall, evidence suggests that the Straumann Bone Level Tapered Implant is a safe option for tooth replacement, whether used immediately or after the area has healed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the immediate versus delayed dental implant placement trial because it explores the optimal timing for dental implants after tooth loss. Unlike the typical approach where implants are placed after a healing period of 16-18 weeks, the immediate placement method involves inserting the implant right after tooth extraction. This could potentially reduce the overall treatment time and improve patient convenience. If successful, immediate placement might offer a quicker and more efficient solution, maintaining bone structure and aesthetics without the extended waiting period associated with traditional methods.

What evidence suggests that this trial's treatments could be effective for tooth loss?

This trial will compare immediate versus delayed placement of the Straumann Bone Level Tapered Implant for tooth loss. Research has shown that using the Straumann Bone Level Tapered Implant immediately after tooth removal is generally effective. In one study, 96% of these implants lasted about five years. Another study found that all implants survived when placed immediately after tooth extraction. Additionally, a one-year follow-up showed a very high survival rate of 98.3%, with few complications. The implant's design allows it to fit securely in the bone right away, supporting its effectiveness. Overall, these findings suggest that immediate placement can be a reliable option for replacing missing teeth. Meanwhile, the trial will also evaluate the delayed placement approach, where the implant is placed after 16-18 weeks of healing, to determine its effectiveness compared to immediate placement. ^{1 4 6 7 8}

Who Is on the Research Team?

David L. Cochran, DDS, PhD, MS

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38454439/

Clinical outcomes of 3-5 years follow-up of immediate ... Results: It was found that 24 out of the 25 (96%) dental implants survived for an average of 57 ± 8.07 months. All of the 24 surviving dental ...

2. withpower.com withpower.com/trial/phase-tooth-loss-2-2016-9a32d

Immediate vs Delayed Dental Implant Placement for Tooth ... Research shows that immediate dental implant placement using Straumann tapered implants is generally safe, with studies reporting a 100% implant survival rate ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jerd.13206

Immediately versus early placed bone‐level‐tapered ... The study demonstrated overall high 1-year implant survival rates (98.3%) and low complication rates. Outcomes between the university setting ...

4. straumann.com straumann.com/content/dam/media-center/straumann/en/documents/scientific-documentation/scientific-review/490.674-en_low.pdf

Straumann® Bone Level Tapered Implant The tapered implant is designed to facilitate immediate placement as it engages the socket bone at the apical and palatal/lingual por- tions of the alveolar ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10509112/

Evaluation of the clinical safety and performance of a narrow ... A systematic review by González-Valls G et al. reported implant survival, success rate, and marginal bone loss at 36 months as 97% (95%-CI: 95.7 ...

6. straumann.com straumann.com/content/dam/media-center/straumann/en/documents/smart/490.192-SmartM-Bone-Level-Tapered-Implant-en.pdf

Bone Level Tapered Implant The Bone Level Tapered Implant (BLT) is a Bone Level Implant suitable for implant treatments at bone level in combination with transmu- cosal or submucosal ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K162890.pdf

Straumann Ø2.9 mm Bone Level Tapered Implants, SC ... Implants can be placed with immediate function on single-tooth or multiple-tooth applications when good primary stability is achieved and with ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/71/NCT02569671/Prot_000.pdf

lstraumann This randomized, controlled, multi-center study will evaluate the clinical and radiographic outcomes of immediate placement of the Straumann® Bone Level Tapered ...