Dental Implants with Bone Grafts for Toothless Patients

JC
RH
Overseen ByRobin Henderson, DDS, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new types of bone grafts for individuals receiving dental implants, especially those missing teeth. The goal is to determine if these new dentin grafts, made from tooth material, perform as well as or better than standard cadaver-derived bone grafts. Researchers will divide participants into groups to receive either the new grafts or the standard ones. Ideal participants are adults missing teeth with well-controlled health conditions. As an unphased trial, this study allows participants to contribute to innovative dental research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using bisphosphonates, you cannot participate.

What prior data suggests that these dental implant and bone graft techniques are safe for toothless patients?

Research shows that using one's own tooth material for grafts, such as the partially demineralized and mineralized dentin grafts under study, is generally safe in dentistry. One study with 16 patients using partially demineralized dentin for dental implants reported no complications, either in the body or at the implant site, indicating the treatment was well-tolerated.

For mineralized tooth grafts, studies also show they are safe. Over time, these grafts have successfully integrated into the jawbone with minimal bone loss. Comparisons with other treatments have found them equally effective and safe.

Overall, current evidence suggests that both types of dentin grafts have been used safely in previous studies, with no major side effects reported. However, individual experiences can vary, so discussing any concerns with a healthcare provider is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these dental graft treatments because they offer innovative approaches for patients needing dental implants. Unlike traditional options such as synthetic bone grafts, these treatments use mineralized and demineralized dentin grafts derived from the patient's own teeth. This method could potentially enhance compatibility and reduce the risk of rejection. Additionally, using partially-demineralized tooth grafts might promote better integration with the jawbone, leading to more successful and stable implant placements. Overall, these treatments represent a promising step forward in dental implant technology by leveraging natural materials for improved outcomes.

What evidence suggests that this trial's treatments could be effective for toothless patients?

Research has shown that partially-demineralized tooth grafts, one of the treatment options in this trial, can effectively preserve bone for dental implants. These grafts help maintain or improve bone levels, similar to other common graft materials. One study found they are a good option for preserving the bone that holds teeth in place.

For mineralized tooth grafts, another treatment option in this trial, studies have highlighted their potential to help regrow bone for implant placement. Specifically, research found these grafts led to about 44% new bone growth. They performed well compared to other materials, showing promising results for dental implants.

This trial studies both types of grafts as alternatives to traditional methods, aiming to provide effective results with fewer complications.678910

Who Is on the Research Team?

RH

Robin Henderson, DDS, MS

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 with well-controlled health conditions, who need dental implants and can consent to study requirements. It's not for those with recent head/neck radiation, active gum disease, uncontrolled health issues, heavy smokers, bisphosphonate users, or pregnant/lactating women.

Inclusion Criteria

I am 18 years or older and considering dental implants.
My chronic illness is well-managed.
You are able to understand and sign a written informed consent form and willing to fulfill all study requirements.

Exclusion Criteria

You smoke more than 10 cigarettes per day.
I am currently using or have used bisphosphonates.
I have active gum disease.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Surgical Intervention

Surgical intervention for implant placement for all groups

1 day
1 visit (in-person)

Follow-up

Participants are monitored for implant stability and bone level changes

6 months
5 visits (in-person)

Restoration

Restoration of the implant by the restorative dentist

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Autogenous Mineralized and Demineralized Dentin Grafts
  • Dental Implant Placement
Trial Overview The trial tests if mineralized or partially demineralized dentin grafts used in dental implant placement are as effective as the standard cadaver bone graft (FDBA) in terms of implant stability and success rates without requiring a second surgical site.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: mineralized tooth graftExperimental Treatment1 Intervention
Group II: Partially-demineralized tooth graftExperimental Treatment1 Intervention
Group III: Freeze-Dried Bone AllograftExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Zimmer Biomet

Industry Sponsor

Trials
383
Recruited
67,800+
Dr. Nitin Goyal profile image

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos profile image

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Citations

Evaluation of the Efficacy of Mineralized Dentin Graft in ...This study evaluates the efficacy of autogenous mineralized dentin graft (AMDG) alone or with xenograft and compares it with those of various graft materials.
Immediate Implantation with Autologous Mineralized ...The purpose of this study was to compare the effectiveness of an autogenous mineralized dentin graft or a deproteinized bovine bone in horizontal gap ...
Clinical Efficacy of Tooth-Bone Graft: A Systematic Review...The objective of this systematic review was to assess the clinical efficacy of the tooth-bone graft as a bone substitute in the oral and maxillofacial ...
Simultaneous implant placement and bone grafting with ...Single-stage implant placement and simultaneous grafting with mineralized particulate allograft showed promising outcome in correcting small and medium sized ...
Regenerating Alveolar Bone for Implant PlacementThe findings suggest that AMD grafts resulted in an average (and 95% confidence interval) of 43.8% [36.6%, 50.8%] newly formed bone, and delayed implant ...
Advances in autogenous dentin matrix graft as a promising ...Autogenous dentin matrix (ADM), derived from a patient's extracted tooth, can be repurposed as an autologous grafting material in reconstructive dentistry.
Long‐term follow‐up of autogenous tooth bone graft blocks ...ABTB is well incorporated and remodelled into cortico‐cancellous bone with dental implant. The shape and volume were maintained with little marginal bone loss.
Immediate Implantation with Autologous Mineralized ...The purpose of this study was to compare the effectiveness of an autogenous mineralized dentin graft or a deproteinized bovine bone in horizontal gap ...
Eighty-Four-Month Clinical Outcomes of Autologous Dentin ...The purpose of the present retrospective study was to evaluate the clinical and radiographic outcome with CBCT, at 84 months of follow-up, of 31 patients with ...
Safety and Efficacy Evaluation of the Ivory Dentin Graft ...Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen Os) for alveolar ridge preservation following tooth extraction.
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