2 implants for Denture, Complete

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Denture, Complete+4 More
1 implant placed surgically in the mandibular midline - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Denture, Complete
  • Complete Lower Denture
  • Mouth, Edentulous
  • Tooth Lost

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement

Year 10
Self-assessed VAS satisfaction with the mandibular denture
Year 1
Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture
Time to provide prosthetic maintenance treatment for the mandibular implant overdenture
Year 10
The frequency of prosthetic maintenance events for the mandibular implant overdenture
Year 10
Cumulative Implant Survival
Year 10
Change in self-assessed VAS satisfaction with the mandibular denture
Week 6
Costs to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention
Time to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention

Trial Safety

Trial Design

2 Treatment Groups

2 implants
1 of 2
1 implant
1 of 2
Active Control

86 Total Participants · 2 Treatment Groups

Primary Treatment: 2 implants · No Placebo Group · N/A

2 implantsActiveComparator Group · 4 Interventions: 2 implants placed surgically in the mandibular canine sites, 2.25mm ball patrices placed on 2 healed implants, Soft reline (Coe Comfort) of the existing complete lower denture, Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower denture · Intervention Types: Procedure, Device, Procedure, Procedure
1 implantActiveComparator Group · 4 Interventions: 1 implant placed surgically in the mandibular midline, Soft reline (Coe Comfort) of the existing complete lower denture, 2.25mm ball patrix placed on 1 healed implant, Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower denture · Intervention Types: Procedure, Procedure, Device, Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,310 Previous Clinical Trials
1,267,933 Total Patients Enrolled
Straumann Canada Ltd.UNKNOWN
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,221 Previous Clinical Trials
24,403,171 Total Patients Enrolled
ITI International Team for Implantology, SwitzerlandOTHER
17 Previous Clinical Trials
727 Total Patients Enrolled
Stephen R. Bryant, DDS, PhDPrincipal InvestigatorUniversity of British Columbia
Joanne N. Walton, DDSStudy DirectorUniversity of British Columbia
Michael I. MacEntee, LDS, PhDStudy DirectorUniversity of British Columbia

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A person who is edentulous and has at least six months experience with conventional complete dentures is a suitable candidate for dental implants.
Currently wearing dentures that are both aesthetically pleasing to the patient and meet the technical standards of the study prosthodontist.
The text states that the participants are available for the duration of the study.
You are able to consent to, and participate in, the treatment provided.
You are medically/psychologically suitable for implant surgery in the judgment of the study dentists.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.