Dental Implants for Complete Lower Dentures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess satisfaction with lower dentures secured by one or two dental implants. The primary goal is to determine if one implant is as effective and satisfying as two. Participants will receive either one implant surgically placed in the middle of the lower jaw or two implants near the corners. Suitable candidates have worn full lower dentures for at least six months and are satisfied with their appearance and fit. As an unphased trial, this study allows participants to contribute to innovative dental research and potentially enhance future denture solutions.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have certain medical conditions like recent heart issues or are on medications that affect bleeding, you might not be eligible to participate.
What prior data suggests that these dental implant techniques are safe for patients?
Research has shown that using a single implant in the middle of the lower jaw is generally safe. Studies report high success rates for these implants, ranging from 90.9% to 100%, indicating they are well-tolerated by most patients. Some risks include possible damage to nearby teeth or tissues and infection at the implant site, but these are common in most dental procedures.
For two implants placed where the canine teeth are in the lower jaw, studies have demonstrated that this method provides good stability for dentures. While risks such as gum swelling or bone loss around the implant exist, these issues are not unique to this treatment. Overall, both one and two implants have demonstrated promising safety, with high satisfaction rates among patients.12345Why are researchers excited about this trial?
Researchers are excited about these dental implant treatments because they offer innovative solutions for stabilizing complete lower dentures. Unlike traditional dentures, which can slip and cause discomfort, these treatments involve surgically placing implants in the lower jaw. With one treatment option, a single implant is placed in the midline of the lower jaw, while the other involves two implants in the canine sites. This approach enhances denture stability and retention, potentially improving comfort and function for individuals who struggle with loose-fitting dentures.
What evidence suggests that this trial's treatments could be effective for improving tolerance to complete lower dentures?
Research has shown that using either one or two implants can significantly enhance the experience of wearing lower dentures. In this trial, participants in one group will receive a single implant placed in the center of the lower jaw. Studies have demonstrated that this approach helps dentures stay in place better and feel more comfortable, with the implant lasting over 90% of the time. Participants in another group will receive two implants, which studies suggest can make chewing easier and reduce the number of maintenance visits compared to using just one implant. Both methods result in higher satisfaction than traditional dentures, offering promising options for those seeking more stable and comfortable dentures.34678
Who Is on the Research Team?
Joanne N. Walton, DDS
Principal Investigator
University of British Columbia
Stephen R. Bryant, DDS, PhD
Principal Investigator
University of British Columbia
Michael I. MacEntee, LDS, PhD
Principal Investigator
University of British Columbia
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Initial surgical and prosthetic treatment for the mandibular implant overdenture intervention
Prosthetic Maintenance
Prosthetic maintenance treatment for the mandibular implant overdenture including adjustments and repairs
Follow-up
Participants are monitored for satisfaction and implant survival
What Are the Treatments Tested in This Trial?
Interventions
- 1 implant placed surgically in the mandibular midline
- 2.25mm ball patrices placed on 2 healed implants
- 2.25mm ball patrix placed on 1 healed implant
- 2 implants placed surgically in the mandibular canine sites
- Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower denture
- Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower denture
- Soft reline (Coe Comfort) of the existing complete lower denture
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Straumann Canada Ltd.
Collaborator
ITI International Team for Implantology, Switzerland
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Citations
Single versus two implant-supported mandibular overdentures
Additionally, AlSourori et al. reported that the placement of a single implant in the mandibular midline improves denture retention [14].
Long‐Term Outcomes of Single‐Implant Mandibular ...
A single midline implant was placed in the edentulous mandible; 93.2% of implants were immediately loaded, and outcomes were followed for 8–10 ...
Single mandibular midline-implant supported overdentures
The present study investigated for the first time the long-term clinical outcome of 11 single midline implants retaining full dentures in the edentulous ...
NCT02117856 | Complete Lower Dentures on 1 or 2 Implants
This study is a randomized clinical trial to compare patient satisfaction and prosthetic outcomes with lower dentures retained by one or two implants.
The Single Midline Implant in the Edentulous Mandible— ...
Single implants with modern rough implant surfaces in the edentulous mandible reveal high implant survival rates of between 90.9 and 100%.
The midline mandibular lingual canal
Implants in the position of lower central incisors are regarded as a safe procedure. Clinicians should however take note of the position of the midline ...
Dental Implants: What You Should Know
Risks Associated with Dental Implant Systems: · Damage to surrounding natural teeth during implant placement · Injury to the surrounding tissues ...
Dental implant surgery
Risks · Infection at the implant site. · Injury or damage to surrounding structures, such as other teeth or blood vessels. · Nerve damage, which ...
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