Dental Implants for Mandibular Overdentures

MK
MK
Overseen ByMary Kathlees Hagstrom, RDA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of dental implants to determine which better secures dentures in individuals without lower teeth. Participants will receive either a parallel-sided or tapered-shaped titanium implant in the middle of their lower jaw. It targets those with full dentures on both the upper and lower jaws who can open their mouth at least 30 millimeters. This trial suits individuals who have no remaining teeth and are in good health without major ongoing medical treatments. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance dental care options.

Will I have to stop taking my current medications?

If you are currently taking chemotherapy, corticosteroids, blood thinners, or psychopharmacological drugs, you will need to stop these medications to participate in the trial.

What prior data suggests that these dental implants are safe for supporting dentures?

Studies have shown that both straight and tapered titanium dental implants are generally safe. For straight implants, research indicates a survival rate of over 99% in the first year. However, tiny titanium particles might be released, potentially causing inflammation in some cases.

A five-year study on tapered implants showed a high survival rate and stable bone levels. Some patients experienced bone loss, with 14.8% losing more than 2 mm of bone after five years. Despite this, the implants did not show further problems over time.

Overall, both types of implants are well-tolerated by most people. However, like any medical procedure, there are risks. Discuss these with a healthcare provider before deciding to join a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about these dental implants because they offer new design options that could improve outcomes for those needing mandibular overdentures. Unlike traditional dental implants which often have a uniform shape, this trial explores both parallel-sided and tapered-shaped titanium implants. The parallel-sided implants could potentially provide more stability in the jaw, while the tapered implants might better mimic the natural shape of tooth roots, allowing for a snugger fit and possibly faster integration with the bone. These design variations might offer patients a more customized and effective solution compared to conventional options.

What evidence suggests that this trial's dental implants could be effective for supporting dentures in the edentulous mandible?

This trial will compare two types of Nobel Biocare titanium dental implants: parallel-sided and tapered-shaped. Studies have shown that both straight and tapered titanium dental implants by Nobel Biocare effectively support dentures. For straight implants, research indicates that more than 95% last for many years, demonstrating long-term success. Similarly, tapered implants are safe and reliable, with minimal bone loss over five years. Both types of implants feature a special TiUltra™ surface that helps form a strong seal with the gums, protecting the jawbone from bacteria. Overall, evidence supports their effectiveness in providing a stable base for dentures.12356

Who Is on the Research Team?

MK

Mats Kronstrom, DDS, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

Inclusion Criteria

The teeth were examined for evidence of pathology, such as cysts, infections in the gum tissue or bone, and remaining roots
Be at least 20 years old and no more than 75 years old.
A patient who is currently present with ASA I or ASA II and does not have any medical contraindications to implant treatment is a candidate for dental implant treatment.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implant Placement and Immediate Loading

A dental implant is placed in the mandible and immediately loaded with the modified denture

1 day
1 visit (in-person)

Follow-up

Participants are monitored for implant stability and bone loss

5 years
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Nobel Biocare titanium dental implants
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Parallel sided implant GroupActive Control1 Intervention
Group II: Tapered shaped implant GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Citations

Highest-level evidence: meta-analysis of a single implant ...A new systematic review and meta-analysis provides the strongest evidence to date confirming the high efficacy of Nobel Biocare implants with the TiUnite ...
Mandibular Overdenture Clinical Trial Comparing Parallel ...Research shows that Nobel Biocare dental implants have been used in various studies, with factors like implant location and radiotherapy affecting their success ...
TiUnite sets the standard for implant surface evidenceEarly implant- and patient-level survival rates both exceed 99% at one year, and late implant-level survival rate is estimated at 95.1% (91.5% at patient-level) ...
Successful clinical outcomes with TiUltra™ surfaceSoft tissue seal. Soft tissue attachment at implant/abutment system protects the underlying bone from the bacteria present in the oral environment.
Evaluation of Stability Changes in Tapered and Parallel ...The aim of this clinical study was to determine the primary stability and to assess changes in implant stability during the early phase of healing, applying the ...
Xeal™ and TiUltra™ | Nobel Biocare United StatesSuccessful clinical outcomes with TiUltra™ surface: Emerging data ... Quantitative in vitro comparison of the thrombogenicity of commercial dental implants.
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