Mandibular Overdenture Clinical Trial Comparing Parallel Sided and Tapered Dental Implants

Overseen By Mary Kathlees Hagstrom, RDA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Chemotherapy, Corticosteroids, Blood thinners, Psychopharmacological

Disqualifiers: Radiation to head/neck, Alcohol/drug abuse, others

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

Compensation: Varies

Number of Visits: 1

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two types of dental screws to help hold removable false teeth in place for people without lower teeth. It aims to see which screw design works better for stability and function. The screws are placed in the jawbone to act like roots for the dentures, making them more secure and improving quality of life.

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.

Is the treatment using Nobel Biocare titanium dental implants generally safe for humans?

Titanium dental implants are generally considered safe, but there are some concerns about the release of titanium particles, which can cause inflammation and other reactions in the surrounding tissues. Studies have shown that these particles can lead to inflammatory responses and potential genotoxic effects, although these effects are not always significant. ^{1 2 3 4 5}

How do Nobel Biocare titanium dental implants differ from other treatments for dental implants?

Nobel Biocare titanium dental implants are unique due to their use of titanium, which is known for its low elastic modulus, corrosion resistance, and minimal potential toxicity. These implants are designed to enhance osseointegration (the process by which the implant integrates with the bone), potentially leading to better stability and faster healing compared to other materials. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Nobel Biocare titanium dental implants?

Research shows that Nobel Biocare dental implants have been used in various studies, with factors like implant location and radiotherapy affecting their success. While some studies report bone resorption (loss of bone), others focus on long-term outcomes and risk factors for implant failure, indicating mixed results. ^{11 12 13 14 15}

Research Team

Mats Kronstrom, DDS, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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.

Timeline

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

Treatment Details

Interventions

• Nobel Biocare titanium dental implants

Participant Groups

Group I: Parallel sided implant Group Active Control 1 Intervention

A Parallel sided titanium dental implant will be placed in the edentulous mandible.

Group II: Tapered shaped implant Group Active Control 1 Intervention

A tapered shaped titanium dental implant will be placed in the edentulous mandible.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

References

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

Two-year outcome with Nobel Direct implants: a retrospective radiographic and microbiologic study in 10 patients. [2022]

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

All-on-4® Treatment Concept for the Rehabilitation of the Completely Edentulous Mandible: A 7-Year Clinical and 5-Year Radiographic Retrospective Case Series with Risk Assessment for Implant Failure and Marginal Bone Level. [2022]

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

Survival of NobelDirect implants: an analysis of 550 consecutively placed implants at 18 different clinical centers. [2013]

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

Implant location and radiotherapy are the only factors linked to 2-year implant failure. [2014]

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

Implant location and radiotherapy are the only factors linked to 2-year implant failure. [2012]

6. Denmark pubmed.ncbi.nlm.nih.gov

What is the impact of titanium particles and biocorrosion on implant survival and complications? A critical review. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Micronucleus assay assessment of possible genotoxic effects in patients treated with titanium alloy endosseous implants or miniplates. [2021]

8. Sweden pubmed.ncbi.nlm.nih.gov

Hypersensitivity to titanium: clinical and laboratory evidence. [2022]

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

Can degradation products released from dental implants affect peri-implant tissues? [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Titanium implants and silent inflammation in jawbone-a critical interplay of dissolved titanium particles and cytokines TNF-α and RANTES/CCL5 on overall health? [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Cytocompatibility and early osseointegration of nanoTiO2-modified Ti-24 Nb-4 Zr-7.9 Sn surfaces. [2015]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Bone regeneration around N-acetyl cysteine-loaded nanotube titanium dental implant in rat mandible. [2013]

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

Vertical distraction osteogenesis using a titanium nitride-coated distractor. [2016]

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

Porous titanium and Ti-35Nb alloy: effects on gene expression of osteoblastic cells derived from human alveolar bone. [2018]

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

The effects of the coupling of titanium implants and dissimilar metal abutments on osteoblast differentiation in vitro. [2013]