What side effects are associated with this type of intervention?

Implant-retained dentures, which involve securing dentures with one or two implants, are a common treatment for toothlessness. Known side effects of this treatment can include discomfort or pain at the implant site, infection, implant failure, and the need for maintenance of the dentures and prosthetic attachments. Additionally, there may be a risk of bone loss around the implant if not properly maintained. Overall, patient satisfaction is generally high, but individual experiences can vary based on factors such as age, health, and socioeconomic status.

What prior FDA approvals exist?

The FDA has approved various treatments for toothlessness, including implant-retained dentures, which are designed to improve the stability and comfort of dentures. These treatments involve the use of dental implants, which are surgically placed into the jawbone to provide a secure anchor for dentures. The clinical trial mentioned compares the efficacy of lower dentures retained by one or two implants, indicating that both single and multiple implant strategies are recognized and utilized in clinical practice. These implant-retained dentures have been shown to enhance patient satisfaction by improving the fit and function of dentures.

What other types of research exist?

Promising novel alternatives to implant-retained dentures for toothless patients in 2024 include: 1) Digital dentures, which utilize advanced 3D printing technology for a precise fit and faster production times. 2) Milled dentures, offering high accuracy and durability through computer-aided design and manufacturing (CAD/CAM). 3) Bioengineered dental implants, which are in development to use stem cells and tissue engineering for natural tooth regeneration. These alternatives aim to improve patient comfort, reduce treatment time, and enhance overall satisfaction.

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Dental Implants for Complete Lower Dentures

N/A

Waitlist Available

Led By Stephen R. Bryant, DDS, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

able to consent to, and participate in, the treatment provided

Be older than 18 years old

Must not have

need for new complete dentures

systemic or neurological disease, including: American Society of Anesthesiologists (ASA) Class 3 with recently diagnosed severe systemic disease, e.g. recent (within 6 months) myocardial infarction or stroke; risks associated with bacteraemia, e.g. immune compromise, steroids, in-dwelling catheters, stents, prosthetic heart valves, etc.; Type 1 diabetes, pituitary and adrenal insufficiency, and untreated hypothyroidism; chronic granulomatous disease, e.g. tuberculosis and sarcoidosis; bone disease, e.g. histiocytosis X, Paget's disease, fibrous dysplasia; history of congenital or acquired uncontrolled bleeding, e.g. coumadin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if using one implant to hold lower dentures is as good as using two implants. It aims to see if patients are just as happy with one implant over time. The study will also check how well the implants last and how often they need maintenance.

Who is the study for?

This trial is for people who have no teeth and are currently using complete lower dentures that look good and work well. They must be able to consent, stay available for the study duration, speak English or have a translator, and be fit for dental implant surgery.

What is being tested?

The study tests patient satisfaction with lower dentures held by either one or two implants over five years. It will compare how satisfied patients feel, how long the implants last, and how often the dentures need maintenance.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, swelling, bruising, bleeding during or after surgery; there might also be issues with denture fit and function requiring adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can agree to and follow the treatment plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need a new set of complete dentures.

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I have a severe health condition like heart issues, immune problems, or uncontrolled bleeding.

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I have had radiation therapy on my head or neck.

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I have had dental implants before.

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I need more surgery before getting a prosthesis.

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My jawbone is too short for dental implants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-assessed VAS satisfaction with the mandibular denture

Secondary study objectives

Change in self-assessed VAS satisfaction with the mandibular denture

Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture

Costs to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: 1 implantActive Control4 Interventions

Participants receive the following: 1 implant placed surgically in the mandibular midline; Soft reline of the existing complete lower denture; 2.25mm ball patrix placed on 1 healed implant; and Reline with 1 retentive matrix in the lower denture.

Group II: 2 implantsActive Control4 Interventions

Participants receive the following: 2 implants placed surgically in the mandibular canine sites; Soft reline of the existing complete lower denture; 2.25mm ball patrices placed on 2 healed implants; and Reline with 2 retentive matrices in the lower denture.

0 / 7Eligibility 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

Implant-retained dentures use dental implants to anchor the dentures securely in the mouth, providing mechanical retention and stability. This method involves placing one or two implants in the jawbone, which act as a stable foundation for the dentures. This approach significantly improves the comfort, chewing efficiency, and overall satisfaction for patients compared to traditional dentures, which can often be unstable and uncomfortable. The enhanced stability from implants helps in better distribution of biting forces, reducing the risk of sore spots and improving the patient's ability to eat and speak confidently.