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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 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.

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.

Find a Location

Who is running the clinical trial?

Straumann Canada Ltd.UNKNOWN
University of British ColumbiaLead Sponsor
1,472 Previous Clinical Trials
2,489,534 Total Patients Enrolled
ITI International Team for Implantology, SwitzerlandOTHER
23 Previous Clinical Trials
955 Total Patients Enrolled

Media Library

1 implant placed surgically in the mandibular midline Clinical Trial Eligibility Overview. Trial Name: NCT02117856 — N/A
Tooth Loss Research Study Groups: 1 implant, 2 implants
Tooth Loss Clinical Trial 2023: 1 implant placed surgically in the mandibular midline Highlights & Side Effects. Trial Name: NCT02117856 — N/A
1 implant placed surgically in the mandibular midline 2023 Treatment Timeline for Medical Study. Trial Name: NCT02117856 — N/A
~8 spots leftby Jun 2027