Dental Implants for Complete Lower Dentures

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Steroids, Coumadin

Disqualifiers: Systemic disease, Bone disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{3 4 6 7 8}

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

I can agree to and follow the treatment plan.

I am happy with my current complete dentures, and a dental specialist agrees they fit well.

I have no natural teeth and have used dentures for at least 6 months.

Exclusion Criteria

I need a new set of complete dentures.

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

I have had radiation therapy on my head or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Initial surgical and prosthetic treatment for the mandibular implant overdenture intervention

6 weeks

Multiple visits for surgical and prosthetic procedures

Prosthetic Maintenance

Prosthetic maintenance treatment for the mandibular implant overdenture including adjustments and repairs

1 year

Regular visits for maintenance

Follow-up

Participants are monitored for satisfaction and implant survival

10 years

Annual follow-up visits

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?

Group I: 1 implant Active Control 4 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 implants Active Control 4 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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Straumann Canada Ltd.

Collaborator

Trials

1

Recruited

90+

ITI International Team for Implantology, Switzerland

Collaborator

Trials

24

Recruited

1,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474779/

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].

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/clr.70065?af=R

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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S030057122500212X

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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02117856

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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10253984/

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%.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23631770/

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 ...

7. fda.gov fda.gov/medical-devices/dental-devices/dental-implants-what-you-should-know

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 ...

8. mayoclinic.org mayoclinic.org/tests-procedures/dental-implant-surgery/about/pac-20384622

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 ...