Dental Implants for Complete Lower Dentures

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

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

Compensation: Varies

Number of Visits: Unknown

86 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment involving dental implants for complete lower dentures?

Research shows that using implants to support mandibular overdentures can lead to minimal bone loss and good implant stability over time. For example, one study found that implants placed in the canine areas of the mandible had low bone resorption and high implant survival rates over two years, suggesting that similar implant-supported treatments can be effective. ^{1 2 3 4 5}

Is it safe to use dental implants for complete lower dentures?

Dental implants are generally safe, but there are risks such as bone loss, accidental displacement, and potential bleeding during surgery. These complications are rare but important to consider. ^{6 7 8 9 10}

How does the treatment of placing implants in the mandibular midline and canine sites for complete lower dentures differ from other treatments?

This treatment involves placing one implant in the mandibular midline and two in the canine sites, which is less invasive and more affordable compared to other methods that may require more implants or complex procedures. It offers a balance of simplicity and effectiveness, providing good retention and stability for dentures, similar to other implant-supported overdentures but with potentially fewer implants needed. ^{6 11 12 13 14}

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

Eligibility Criteria

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 can communicate in English or have someone who can translate for me.

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Early versus late loading of unsplinted TiUnite surface implants supporting mandibular overdentures: a 2-year report from a prospective study. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Implant Position on Clinical and Radiographic Outcomes of Locator-Retained Mandibular Overdentures: A 1-Year Prospective Study. [2019]

3. Denmark pubmed.ncbi.nlm.nih.gov

5-year randomized multicenter clinical trial on single dental implants placed in the midline of the edentulous mandible. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Comparison between Two Design Concepts of Four Implants Placement Used to Support Telescopic Mandibular Overdenture: A Prospective Study of Implant Marginal Bone Height Changes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Differences two years after tooth extraction in mandibular bone reduction in patients treated with immediate overdentures or with immediate complete dentures. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of edentulous mandibles by means of four TiUnite implants after one-stage surgery: a 1-year retrospective study of 75 patients. [2019]

7. Scotland pubmed.ncbi.nlm.nih.gov

Accidental displacement of a dental implant into the submandibular space during explantation. [2018]

8. Scotland pubmed.ncbi.nlm.nih.gov

Lingual concavities in the mandible: a morphological study using cross-sectional analysis determined by CBCT. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Hemorrhage of the floor of the mouth resulting from lingual perforation during implant placement: a clinical report. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

The midline mandibular lingual canal: importance in implant surgery. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Mandibular implant-retained complete overdenture using retentive abutments: a case report. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Case report: prosthodontic treatment for the transmandibular implant. [2004]

13. United States pubmed.ncbi.nlm.nih.gov

Implant-supported overdentures. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

Implant reconstruction of the jaws and craniofacial skeleton. [2022]