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Different Interventions for Complete Lower Dentures
Department of Oral Health Sciences, University of British Columbia, Vancouver, Canada
Targeting 4 different conditionsSoft reline (Coe Comfort) of the existing complete lower denture +6 moreN/AWaitlist AvailableLed by Stephen R. Bryant, DDS, PhDResearch Sponsored by University of British ColumbiaEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
edentulous and with at least six month's experience with conventional complete dentures
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will compare patient satisfaction with lower dentures retained by one or two implants. The main aim is to investigate patient satisfaction between and within groups with mandibular dentures retained by one or two implants over five years.
Eligible Conditions
- Toothless
- Tooth Loss
- Dentures
- Complete Lower Dentures
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have no natural teeth and have been wearing full dentures for at least six months.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-assessed VAS satisfaction with the mandibular denture
Secondary outcome measures
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 moreAwards & 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: 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.
Group II: 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.
Find a Location
Who is running the clinical trial?
Straumann Canada Ltd.UNKNOWN
University of British ColumbiaLead Sponsor
1,381 Previous Clinical Trials
1,944,900 Total Patients Enrolled
ITI International Team for Implantology, SwitzerlandOTHER
21 Previous Clinical Trials
879 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain health conditions that may increase your risk for complications during the study, such as recent heart attack or stroke, weakened immune system, certain hormonal imbalances, chronic tuberculosis, and bone diseases. Additionally, if you are taking blood thinners, you must have your bleeding under control before participating in the study.The study dentists believe that you are not physically or mentally able to undergo the required surgery.You require new dentures to replace all your teeth.You require surgery before getting prosthetics.You have no natural teeth and have been wearing full dentures for at least six months.You have received radiation treatment on your head or neck in the past.You have had dental implants in the past.
Research Study Groups:
This trial has the following groups:- Group 1: 2 implants
- Group 2: 1 implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any enrolment opportunities open to participants in this trial?
"Data provided on clinicaltrials.gov shows that, although initially posted in November 2002 and last updated June 2019, this trial is no longer recruiting participants. However, there are still 61 other trials looking for volunteers at the moment."
Answered by AI
Who else is applying?
What site did they apply to?
Department of Oral Health Sciences, University of British Columbia
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am having difficulty with my current dentures. From improper fit, loss of taste in food & overall I am not happy with the overall aesthetic of me teeth.
PatientReceived 2+ prior treatments
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